Tag Archives: Clostridioides difficile clinical trials

Acurx Announces that All Patients Demonstrated Clinical and Sustained Cure in Ph2A Open-Label Trial of Ibezapolstat for the Treatment of a C. difficile Infection

 

 

 

 

– Ibezapolstat is the first of an entirely new class of antibiotics with a novel mechanism of action, a DNA polymerase IIIC inhibitor, to enter clinical efficacy trials

– 10 of 10 patients enrolled in the Ph2A trial met the study’s primary and secondary efficacy 

– No C. difficile was detected in any of the 65 fecal samples tested by Day 3 of treatment and thereafter

– Compelling evidence of efficacy allows early termination of Segment 2A and advancement to Segment 2B

C. difficile bacteria remain on CDC Urgent Threat list, highlighting the need for new CDI treatments

– Ibezapolstat is FDA QIDP and Fast Track Designated for priority review

Acurx Pharmaceuticals, LLC,  a privately held, clinical-stage biopharmaceutical company developing an entirely new class of antibiotics for difficult-to-treat bacterial infections, announced today (November 5, 2020) that all 10 patients (100%) with mild-to-moderate CDI enrolled in this Ph2A open-label clinical trial met the study’s primary and secondary efficacy endpoints following treatment with orally administered ibezapolstat given 450 mg twice daily for 10 days.  FDA has granted Qualified Infectious Disease Product (QIDP) designation and Fast-Track status to ibezapolstat for patients with CDI.

In this Phase 2 clinical trial, Segment 2A was designed to enroll up to 20 patients with a data review planned by a Trial Oversight Committee after 10 patients completed the trial. All 10 patients enrolled in the trial met the study’s primary and secondary efficacy endpoints of Clinical Cure at end of treatment and Sustained Clinical Cure of no recurrence of CDI at the 28-day follow-up visit.  Ibezapolstat was well-tolerated, with no serious adverse events (SAEs) reported in the trial. Based on these successful treatment results, and in consultation with the Company’s medical advisors, the Company has terminated enrollment in Segment 2A early and will advance to Segment 2B.   These results also represent the first-ever clinical validation of DNA polymerase IIIC as a therapeutically relevant antibacterial target.

Dr. Kevin Garey, Professor and Chair, University of Houston College of Pharmacy and the Principal Investigator for the microbiome aspects of the trial stated, “Data from my laboratory confirm that ibezapolstat eradicated C. difficile in all fecal samples tested by Day 3 of treatment in this patient population with mild or moderate CDI.  Our ongoing work will characterize the effects of ibezapolstat on the intestinal microbiome in these CDI patients.  A strength of this development program will be the ability to compare the microbiome results in CDI patients to our prior favorable effects relative to vancomycin previously demonstrated in the Phase 1 healthy volunteer trial.”

Stuart Johnson, MD, Professor of Medicine at Loyola University, a CDI expert and an Acurx Scientific Advisory Board (SAB) member, noted, “After reviewing Segment 2A , the SAB is encouraged by the promising results and fully support early termination and advancement to the Ph2B Segment with the next enrolled patient.  The SAB looks forward to successful results from Segment 2B that could pave the way for an important new antibiotic class for the treatment of CDI which remains an area of clear medical need.”

These data will be presented at the 8th Annual International C. diff.  Virtual Conference and Virtual Health Expo on November 14, 2020, https://cdiff2020.com which coincides with the US Centers for Disease Control and Prevention (CDC) declaration of November as Clostridioides difficile Awareness Month.

Robert J. DeLuccia, Co-Founder & Managing Partner of Acurx, stated, “We are very excited by these excellent results allowing early termination of our Phase 2A Segment at 10 patients. We are looking forward to starting our Phase 2B Segment early next year with expectation for completion by the end of next year”.   He further stated, “since ibezapolstat is the first DNA polymerase IIIC inhibitor to advance into clinical trials, this achieves the first human validation of our bacterial target and will enable further development of our pipeline of novel oral and I.V. antibiotics with the same bacterial target and mechanism of action.  Our new compounds are in pre-clinical development to treat other Gram-positive life-threatening infections in skin/skin structure, community-acquired pneumonia, bone & joint, and bacteremia. The spectrum of activity of Acurx’s DNA pol IIIC inhibitors includes pathogens resistant to currently available antibiotics and classified as priority pathogens by the WHO, CDC, and FDA, all of whom emphasize the need for new classes of antibiotics to prepare for the next global infectious disease pandemic, antimicrobial resistance.”

About the Phase 2 Clinical Trial.  In Segment 2A of this trial, 10 subjects with diarrhea caused by C. difficile were treated with ibezapolstat 450 mg orally for 10 days and evaluated for clinical cure. All cured subjects were followed for a sustained clinical cure at 28 ± 2 days. In Segment 2B, approximately 64 additional subjects with CDI will be enrolled and randomized in a 1:1 ratio to either ibezapolstat 450 mg every 12 hours or vancomycin 125 mg orally every 6 hours for 10 days and will be followed for 28 ± 2 days for recurrence. The two treatments will be identical in appearance, dosing times, and the number of capsules administered to maintain the blind. Subjects in both segments will be evaluated for clinical and sustained clinical cure, safety, and tolerability. All subjects in both segments will have stool samples tested for microbiome profiles.  Additional information about the trial, including eligibility criteria, can be found at www.clinicaltrials.gov (Study identifier: NCT04247542).

About Clostridioides Difficile Infection (CDI).  Clostridioides (formerly Clostridium) difficile, also known as C. difficile or C. diff, is one of the most common causes of healthcare-associated infections in U.S. hospitals (Lessa, et al, 2015, New England Journal of Medicine).  Recent estimates suggest C. difficile approaches 500,000 infections annually in the United States and are associated with approximately 20,000 deaths. (Guh, 2020, New England Journal of Medicine).  Based on internal estimates including a recurrence rate of approximately 20%, we believe the annual incidence in the U.S. approaches 600,000.

About the C Diff Foundation:  The Company recognizes the month of November as                    C. Difficile Awareness Month as designated by the US Centers for Disease Control and Prevention (CDC) and supports the work of the C Diff Foundation in educating and advocating for the Prevention, Treatments, Clinical Trials, and Environmental Safety of Clostridioides difficile (C.difficile) Infections worldwide. https://cdifffoundation.org/.  The C Diff Foundation recently announced the release of the C diff and You app, available from the Apple Store (apple.com) and Google Store (play.google.com).  Developed with patients, family members, and caregivers in mind, the app provides information about C. difficile infection prevention, treatments, clinical trials, support, guidelines, environmental safety, and nutrition.

The U.S. Center for Diseases Control 2019 Update on Antimicrobial Resistance.  https://www.cdc.gov/drugresistance/pdf/threats-report/2019-ar-threats-report-508.pdf  CDC reported that more than 2.8 million antibiotic-resistant infections occur in the U.S. each year and more than 35,000 people die as a result, nearly twice as many annual deaths as previously reported by CDC in 2013. These deaths are attributed to antimicrobial-resistant pathogens including Enterococcus (including vancomycin-resistant strains or VRE), Staphylococcus (including methicillin-resistant strains or MRSA), and Streptococcus (including antibiotic-resistant strains), which are the targets of the Company’s antibiotic pipeline currently in preclinical development and also eligible for QIDP and FDA-Fast-Track-Designation for priority review.

About ibezapolstat, FDA QIDP, and Fast Track Designation.  In June 2018, FDA granted Qualified Infectious Disease Product (QIDP) designation to ibezapolstat as an oral treatment for patients with CDI.  In addition, in January 2019, FDA granted Fast Track designation to ibezapolstat for the oral treatment for patients with CDI.

FDA’s QIDP Designation provides that ibezapolstat will be eligible to benefit from certain incentives for the development of new antibiotics provided under the Generating Antibiotic Incentives Now Act (the GAIN Act). These incentives include Priority Review and eligibility for Fast Track status, the latter of which Acurx has already applied for and been granted by the FDA.  Further, if ultimately approved by the FDA, ibezapolstat is eligible for an additional five-year extension of Hatch-Waxman marketing exclusivity.

FDA Fast Track Designation is a process designed to facilitate the development and expedite the regulatory pathway of new drugs to treat serious or life-threatening conditions and that fill a high unmet medical need. Ibezapolstat is a novel, first-in-class, orally administered antibacterial. It is the first of a new class of DNA polymerase IIIC inhibitors in clinical development by Acurx to treat bacterial infections.

About DNA polymerase IIIC (pol IIIC).  Working in scientific collaboration with WuXi AppTec, Acurx has identified additional potential therapeutic candidates to add to its pipeline of DNA pol IIIC inhibitors. Nonclinical research has established the mechanism of action of ibezapolstat as the selective inhibition of the enzyme DNA polpol IIIC, which is required for bacterial replication and pathogenesis. This enzyme is found only in certain Gram-positive bacteria, including C. difficile as well as the pathogens Enterococcus (including vancomycin-resistant strains or VRE), Staphylococcus (including methicillin-resistant strains or MRSA), and Streptococcus (including antibiotic-resistant strains). Accordingly, chemically related molecules with the same mechanism of action as ibezapolstat have the potential to treat a variety of serious systemic Gram-positive infectious diseases.

About Acurx Pharmaceuticals, LLC.  Acurx Pharmaceuticals is a privately-held clinical-stage biopharmaceutical company focused on developing new antibiotics for difficult-to-treat infections. Acurx’s approach is to develop antibiotic candidates that target the DNA polymerase IIIC enzyme and its R&D pipeline includes early-stage antibiotic candidates that target other Gram-positive bacteria, including Methicillin-Resistant Staphylococcus aureus (MRSA), Vancomycin-Resistant Enterococcus (VRE), and Penicillin-Resistant Streptococcus pneumoniae (PRSP).

For more information, please visit our website at www.acurxpharma.com.

Any statements in this press release about our future expectations, plans, and prospects, including statements regarding our strategy, future operations, prospects, plans and objectives, and other statements containing the words “believes,” “anticipates,” “plans,” “expects,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including whether ibezapolstat will benefit from the QIDP designation; whether ibezapolstat will advance through the clinical trial process on a timely basis; whether the results of the clinical trials of ibezapolstat will warrant the submission of applications for marketing approval, and if so, whether ibezapolstat will receive approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies where approval is sought; whether, if ibezapolstat obtains approval, it will be successfully distributed and marketed; and other factors. In addition, the forward-looking statements included in this press release represent our views as of November 5, 2020.  We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so.

Investor Contact:
Acurx Pharmaceuticals, LLC
David P. Luci, Co-Founder & Managing Partner
917-533-1469; davidluci@acurxpharma.com

SOURCE Acurx Pharmaceuticals, LLC

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DEINOVE: DNV3837 Antibiotic Candidate: the Phase II Clinical Trial to Treat CDI Continues in the USA

DEINOVE is a French biotech company that uses its lead generation platform to develop innovative anti-infective drugs, is pursuing the Phase II clinical trial of its antibiotic candidate DNV3837, in a context where U.S. hospitals are still fighting the COVID-19 pandemic. The Company thanks the clinicians for their commitment to this trial, as they face an unprecedented health crisis.

DNV3837 targets the treatment of Clostridioides difficile gastrointestinal infections (CDI), a pathogen classified as urgent threat by the U.S. Centers for Disease Control and Prevention (CDC). A Phase II clinical trial, launched in early 2020 in the United States, is evaluating the efficacy of DNV3837 in patients, following promising Phase I data. To date, DEINOVE is the only French biotech with a small molecule in clinical development, fully owned by the company, in the field of antibiotics.

This trial continues in the United States despite the COVID-19 outbreak. Several of the investigation centers have maintained their clinical research activities and continue to screen and include patients. DEINOVE scientific team and the CRO Medpace are closely monitoring the situation.

« We are grateful to the clinicians for doing their utmost to ensure that the clinical trial runs smoothly. We are surrounded by a team that is aware of the therapeutic stakes and the potential of our solution in development, and we thank them for this. In the current health conditions in the United States, where hospitals are overcrowded, we could have feared a suspension of the trial, » says Dr. Yannick Plétan, Acting Chief Medical Officer responsible for the clinical trial. «Conversely, the COVID-19 outbreak – which mainly affects the elderly – and the heavy antibiotic treatments administered to combat possible bacterial co-infections, are factors conducive to the development of severe Clostridioides difficile infections targeted by DNV3837. We are concerned, however, about the irrational use of antibiotics, which would have long-term public health consequences. »

On June 1st of this year, the WHO warned of the increasing rates of antimicrobial resistance, boosted by the current health crisis. ” The COVID19 pandemic has led to an increased use of antibiotics, which ultimately will lead to higher bacterial resistance rates that will impact the burden of disease and deaths during the pandemic and beyond,”worried Dr Tedros Adhanom Ghebreyesus, WHO Director-General1. According to him, the threat of antimicrobial resistance is “one of the most urgent challenges of our time “. He also recalled that only small proportion of COVID-19 patients need antibiotics to treat subsequent bacterial infections.

ABOUT CLOSTRIDIOIDES DIFFICILE INFECTIONS (CDI)

40% of patients suffering a Clostridioides difficile infection (CDI) have severe forms, with mortality rates as high as 50%. Over the past 20 years, CDIs tended to increase significantly in incidence and severity, particularly due to the development of new hypervirulent strains and the high risk of recurrence. The US Center for Disease Control and Prevention (CDC) recently identified CDIs as one of the leading causes of healthcare-associated infections before Staphylococcus aureus (MRSA2) infections. In 2017, in the United States, there were an estimated 223,900 cases in hospitalized patients and 12,800 deaths3. This disease does not affect the United States only, recent studies4 show that the incidence of this type of infection is vastly underestimated in other parts of the world such as Europe and Asia.

To date, there are no therapeutic solutions for patients with severe gastrointestinal infections. Since the oral route is compromised, the available treatments, which are mostly oral treatments, struggle to reach the intestine because of the patient’s pathological condition (reduced gastrointestinal motility, intubation, intestinal perforation, etc.), and the few antibiotics that could be administered intravenously (IV), do not cross the gastrointestinal barrier and therefore do not reach the site of infection.

ABOUT THE DNV3837 ANTIBIOTIC CANDIDATE

DNV3837 – a prodrug5 of the DNV3681 molecule (also known as MCB3681) – is a narrow-spectrum, hybrid oxazolidinone-quinolone synthetic antibiotic targeting only Gram-positive bacteria. It is developed as a highly active 1st line treatment targeting Clostridioides difficile.

It has demonstrated significant efficacy and superiority to reference treatments (fidaxomicin in particular) against isolates of C. difficile, regardless of their virulence (including the hyper virulent BI/NAP1/027 strain).

DNV3837 is an intravenous antibiotic that, when converted to its active form DNV3681, crosses the gastrointestinal barrier and accumulates in the intestinal lumen, allowing it to precisely target the infection site. Several Phase I trials (on approx. a hundred healthy volunteers) have shown a high concentration of the antibiotic in stools, a strong marker of its presence in the intestine. It has also demonstrated its ability to eliminate Clostridioides bacteria without affecting the gut microbiota. It has also shown an acceptable tolerance profile.

FDA granted the DNV3837 drug with Qualified Infectious Disease Product (QIDP) designation and Fast Track status.

ABOUT THE PHASE II CLINICAL TRIAL TESTING DNV3837 IN CDI

The antibiotic candidate DNV3837 has been in a Phase II trial since the end of January 2020. The purpose of this trial is to evaluate its efficacy in CDI (through monitoring of symptoms, stool analysis, etc.), as well as to consolidate the safety and pharmacokinetic data.

This trial is taking place in the United States in two stages:

  • In the first phase, a cohort of 10 patients with moderate to severe CDI is treated with DNV3837. At the end of this phase, the DSMB6 has scheduled to review the interim results.
  • The second phase involves 30 patients with severe CDI. This is an open-label randomized trial testing DNV3837 (in 2/3 of patients) against an approved standard of care7 (1/3 of patients) for comparison purposes.

To read article in its entirety please click on the following link to be redirected:

https://www.businesswire.com/news/home/20200715005695/en/DEINOVE-DNV3837-Antibiotic-Candidate-Phase-II-Trial

Acurx Pharmaceuticals Phase 2 Clinical Trial of ibezapolstat Is In Progress

Acurx Pharmaceuticals, LLC (“Acurx” or the “Company”), a privately held, clinical stage biopharmaceutical company developing new antibiotics for difficult-to-treat bacterial infections, announced on July 27th, 2020 that a Phase 2 clinical trial of the Company’s lead antibiotic product candidate is in progress. In this trial, orally-administered ibezapolstat given 450 mg twice daily for 10 days will be evaluated for the treatment of patients with CDI. FDA has granted Qualified Infectious Disease Product (QIDP) designation and Fast-Track status to ibezapolstat for patients with CDI.

Up to 6 study centers in the U.S. will participate in the first segment (Segment 2A) of the trial. Additional information about the trial, including eligibility criteria, can be found at www.clinicaltrials.gov (Study identifier: NCT04247542). This Phase 2, multicenter, open-label single-arm segment (Segment 2A) will be followed by a double-blind, randomized, active-controlled segment (Segment 2B), and is designed to evaluate both clinical cure and sustained clinical cure, safety, and pharmacokinetics. All patients in both segments will have stool samples tested for ibezapolstat concentrations and microbiome effects. Pharmacokinetic testing for systemic exposure will be performed on blood samples in Segment 2A. All of the first 6 patients enrolled in the trial have met the study’s primary endpoint, Clinical Cure at end of treatment. All patients who have reached the 30-day follow-up milestone, no recurrence of CDI, have achieved Sustained Clinical Cure, the study’s secondary endpoint. Ibezapolstat has been well-tolerated in all patients to date. After the first 10 patients have completed treatment, the study’s Trial Oversight Committee will assess the ibezapolstat safety profile in relationship to treatment outcomes and will advise the company on any recommended trial modifications which could include early termination of Phase 2A and acceleration of the double-blind Segment 2B.

Robert J. DeLuccia, Co-Founder & Managing Partner of Acurx, stated “With today’s heightened awareness of antimicrobial resistance, even more so in the current Covid-19 environment, and the need for new classes of antibiotics to fight this global crisis, we are very excited to advance ibezapolstat to this stage of clinical development.” He further stated, “This is a significant value-creating development milestone for our Company. We believe this now clinically validated target of inhibition of bacterial DNA pol IIIC will pave the way forward for our pipeline of new oral/I.V. antibiotics in pre-clinical development to treat other Gram-positive life-threatening infections in skin/skin structure, community acquired pneumonia, bone & joint and bacteremia. This will include pathogens resistant to currently available antibiotics, and classified as priority pathogens by the WHO, CDC and FDA, all of whom emphasize the need for new classes of antibiotics to prepare for the next global infectious disease threat.”

Additionally, the U.S. Center for Diseases Control recently issued its 2019 update on antimicrobial resistance https://www.cdc.gov/drugresistance/pdf/threats-report/2019-ar-threats-report-508.pdf and reaffirmed that CDI remains an URGENT threat causing at least 12,800 deaths in 2017, highlighting the need for new antibiotics, particularly those with a novel mechanism of action. It further reported that more than 2.8 million antibiotic-resistant infections occur in the U.S. each year and more than 35,000 people die as a result, nearly twice as many annual deaths than previously reported by CDC in 2013. These deaths are attributed to antimicrobial-resistant pathogens including Enterococcus (including vancomycin-resistant strains or VRE), Staphylococcus (including methicillin-resistant strains or MRSA), and Streptococcus (including antibiotic-resistant strains), which are the targets of Company’s second antibiotic candidate currently in preclinical development.

About the Phase 2 Clinical Trial.  In Segment 2A of this trial, up to 20 subjects with diarrhea caused by C. difficile will be treated with ibezapolstat 450 mg orally for 10 days and evaluated for clinical cure. All cured subjects will be followed for sustained clinical cure at 28 ± 2 days. In Segment 2B, approximately 64 additional subjects with CDI will be enrolled and randomized in a 1:1 ratio to either ibezapolstat 450 mg every 12 hours or vancomycin 125 mg orally every 6 hours for 10 days and followed for 28 ± 2 days for recurrence. The two treatments will be identical in appearance, dosing times, and number of capsules administered to maintain the blind. Subjects in both segments will be evaluated for clinical and sustained clinical cure, safety, and tolerability. All subjects in both segments will have stool samples tested for microbiome profiles.
Additional information about the trial, including eligibility criteria can be found at: www.clinicaltrials.gov (Study identifier: NCT04247542).

About ibezapolstat, FDA QIDP and Fast Track Designation.  In June 2018, FDA granted Qualified Infectious Disease Product (QIDP) designation to ibezapolstat as an oral treatment for patients with CDI. In addition, in January 2019, FDA granted Fast Track designation to ibezapolstat for the oral treatment for patients with CDI. 

FDA Fast Track Designation is a process designed to facilitate the development and expedite the regulatory pathway of new drugs to treat serious or life-threatening conditions and that fill a high unmet medical need. Ibezapolstat is a novel, first-in-class, orally administered antibacterial. It is the first of a novel class of DNA polymerase IIIC inhibitors under development by Acurx to treat bacterial infections. Acurx acquired ibezapolstat from GLSynthesis, Inc. in February 2018.

FDA’s QIDP Designation provides that ibezapolstat will be eligible to benefit from certain incentives for the development of new antibiotics provided under the Generating Antibiotic Incentives Now Act (the GAIN Act). These incentives include Priority Review and eligibility for Fast Track status, the latter of which Acurx has already applied for and been granted by FDA. Further, if ultimately approved by the FDA, ibezapolstat is eligible for an additional five-year extension of Hatch-Waxman marketing exclusivity. Ibezapolstat is being developed as a targeted, narrow spectrum oral antibiotic for the treatment of patients with CDI. Acurx is planning to advance ibezapolstat into a Phase 2 clinical trial in first quarter 2020. The CDC (Centers for Disease Control & Prevention) has designated Clostridium difficile bacteria as an urgent threat highlighting the need for new antibiotics to treat CDI.

Summit Therapeutics plc Phase 2 Clinical Trial Ridinilazole In Development For the Treatment of C. difficile Infection

Summit Announces Publication of Phase 2 Clinical Analyses of Gut Microbiome Health

July 13, 2020 – Summit Therapeutics plc announced the publication of data from the Phase 2 clinical trial of the company’s precision antibiotic, ridinilazole, in development for the treatment of C. difficile infection (‘CDI’) in the American Journal of Physiology – Gastrointestinal and Liver Physiology. The data published in collaboration with researchers at Tufts University and Tufts Medical Center demonstrated that ridinilazole’s microbiome preservation resulted in a gut environment expected to inhibit the growth of C. difficile. In contrast, vancomycin treatment resulted in a gut environment that may more highly favor the growth of C. difficile. The difference in gut environment could explain the approximately 60% relative reduction in recurrence observed in patients treated with ridinilazole over vancomycin in the Phase 2 trial.

“This is the first scientific article ever to show the effect of antibiotics treating CDI on the bile acid composition in the human gut. In addition, CoDIFy is the first clinical study to highlight the differential effects of antibiotics on bile acids, which are known to create environments that can either promote or protect against CDI,” said Dr. Ventzislav Stefanov, Executive Vice President and President of Discuva. “The protective gut environment observed after ridinilazole treatment, compared to vancomycin, provides a strong rationale for the higher sustained clinical response observed in patients taking ridinilazole in the CoDIFy clinical trial.”

The Phase 2 clinical trial enrolled 100 patients, half of whom received ridinilazole and the other half vancomycin. The publication, “Ridinilazole, a narrow spectrum antibiotic for treatment of Clostridioides difficile infection, enhances preservation of microbiota-dependent bile acids,” was authored by X. Qian, K. Yanagi, A. Kane, N. Alden, M. Lei, D. Snydman, R. Vickers, K. Lee and C. Thorpe. In the published data, there was a higher ratio of pro-C. difficile to anti C.-difficile bile acids at the start of treatment for both ridinilazole- and vancomycin-treated patients. This was expected, as patients who get CDI have perturbed microbiomes. However, during treatment, patients treated with vancomycin showed a further decrease in anti-C. difficile bile acids and had stools dominated by pro-C. difficile bile acids. In contrast, this did not occur in ridinilazole-treated patients. By the end of the study period, ridinilazole-treated patients’ bile acid ratios trended towards a healthy, non-CDI state. These results support the data from the Phase 2 clinical trial, in which patients receiving ridinilazole showed a statistically significant improvement in sustained clinical responses.

SOURCE: https://seekingalpha.com/pr/17929120-summit-announces-publication-of-phase-2-clinical-analyses-of-gut-microbiome-health