Tag Archives: CoDiFy Trial Study Ridinilazole

Summit Therapeutics Doses First Patient in Global Phase 3 Clinical Trials Oral Antibiotic ridinilazole for C.difficile Infection Treatment

Summit Doses First Patient in Phase 3 Clinical Trials of Precision Antibiotic Ridinilazole for C. Difficile Infection

  • Trials Aim to Show Superiority of Ridinilazole Over Standard of Care Treatment Vancomycin
  • Health Economic Outcomes Included to Support Commercialisation

FROM PRESS RELEASE:

Oxford, UK, and Cambridge, MA, US, 13 February 2019 – Summit Therapeutics plc (NASDAQ: SMMT, AIM: SUMM), a leader in new mechanism antibiotic innovation, today announces it has dosed the first patient in the global Phase 3 clinical trials of its precision oral antibiotic, ridinilazole, for C. difficile infection (‘CDI’). The trials aim to show superiority of ridinilazole over the standard of care, vancomycin, in a measure that combines CDI cure and recurrence called sustained clinical response (‘SCR’). Ridinilazole achieved statistical superiority over vancomycin in SCR in a Phase 2 clinical trial.

“Starting our Phase 3 programme is an important milestone for Summit,” commented Mr Glyn Edwards, Chief Executive Officer of Summit. With positive results, we believe ridinilazole could be positioned as the drug of choice in the front-line treatment of CDI, which potentially provides patients with sustained cures and hospitals with compelling cost savings.”

“Ridinilazole is the trail-blazer in our growing pipeline of innovative product candidates targeting serious infectious diseases,” added Dr David Roblin, President of R&D of Summit. “Our Phase 3 programme exemplifies our broader strategy of demonstrating significant advantages over current standards of care by gathering a carefully considered package of clinical and economic data to address the needs of physicians, regulators, healthcare providers, payors and, above all, patients.”

The Phase 3 clinical programme comprises two global, randomised, double-blind, active-controlled clinical trials called Ri-CoDIFy 1 and Ri-CoDIFy 2. The trials will be run concurrently with each expected to enrol approximately 680 patients at sites in North America, Latin America, Europe, Australia and Asia. Upon confirmation of a positive CDI toxin test, patients will be randomised to receive either ridinilazole (200mg twice a day) or vancomycin (125mg four times a day) for ten days. The primary endpoint of both clinical trials will test for superiority in SCR, defined as cure at the end of treatment and no recurrence of CDI within 30 days post-treatment. Secondary endpoints include cure at the end of treatment and SCR at 60 days and 90 days post-treatment. Additional endpoints will evaluate the impact of ridinilazole and vancomycin on the gut microbiome, which is known to protect against CDI. The Phase 3 clinical trials also include health economic outcome measures, such as readmission rates and length of hospital stay, to help support the commercialisation of ridinilazole, if approved.

Top-line data from the Phase 3 programme are expected to be reported in the second half of 2021.

The clinical and regulatory development of ridinilazole is being funded in part with Federal funds from the US Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority (‘BARDA’), under Contract No. HHS0100201700014C. Summit is eligible to receive up to $62 million in funding from BARDA to support the clinical and regulatory development of ridinilazole.

About Ridinilazole
Ridinilazole is an oral small molecule new mechanism antibiotic that is designed to selectively kill C. difficile, thereby preserving patients’ protective gut microbiome and leading to sustained CDI cures. In a Phase 2 proof of concept trial in CDI patients, ridinilazole showed statistical superiority in sustained clinical response (‘SCR’) rates compared to the standard of care, vancomycin. In that trial, SCR was defined as clinical cure at end of treatment and no recurrence of CDI within 30 days of the end of therapy. Ridinilazole was also shown to be highly preserving of the gut microbiome in the Phase 2 proof of concept trial, which was believed to be the reason for the improved clinical outcome for the ridinilazole-treated patients. In addition, ridinilazole preserved the gut microbiome to a greater extent than the marketed narrow-spectrum antibiotic fidaxomicin in an exploratory Phase 2 clinical trial. Ridinilazole has received Qualified Infectious Disease Product (‘QIDP’) designation and has been granted Fast Track designation by the US Food and Drug Administration. The QIDP incentives are provided through the US GAIN Act and include a potential extension of marketing exclusivity for an additional five years upon FDA approval.

About Summit Therapeutics
Summit Therapeutics is a leader in antibiotic innovation. Our new mechanism antibiotics are designed to become the new standards of care for the benefit of patients and create value for payors and healthcare providers. We are currently developing new mechanism antibiotics for infections caused by C. difficile, N. gonorrhoeae and ESKAPE pathogens and are using our proprietary Discuva Platform to expand our pipeline.

For more information, visit www.summitplc.com

Summit Therapeutics PLC Is Granted A “Composition Of Matter” Patent By U.S. Patent and Trademark Office

In The News:

C. difficile Infection–  Treatment On The Horizon

Summit Therapeutics PLC

summit

The US patent and trademark office have granted a “composition of matter” patent.

It gives a period of exclusivity for ridinilazole in the United States until at least December 1, 2029, with the possibility of being extended.

It’s been a busy period for the firm and Glyn Edwards, Chief Executive said: “This new patent grant in one of our potential major commercial markets substantially strengthens our intellectual property estate protecting our novel CDI antibiotic ridinilazole and supports our efforts to maximize the potential of this promising compound.”

“We are focused on our CDI and DMD programmes and today’s news, combined with the recently announced expansion advancing  of our PhaseOut DMD trial, highlights their continuing excellent progress as we seek to have a meaningful impact on the lives of patients living with these serious diseases.”

In a Phase 2 clinical trial, ridinilazole showed statistical superiority over vancomycin – the standard of care medicine –  in rates of sustained clinical response, an endpoint that captures both initial cure and recurrence of the disease.

 

To read article in its entirety:

http://www.proactiveinvestors.co.uk/companies/news/125364/summit-therapeutics-plc-boosted-by-us-patent-for-c-diff-antibiotic-125364.html

 

*Please note – The C Diff Foundation does not endorse this product or any product and this posting is strictly for informational purposes only.

Summit Therapeutics To Present Further Data Showing Superiority Of Its New Antibiotic At the 26th ECCMID Conference

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Summit Therapeutics is to present further data showing the superiority of its new antibiotic for hospital superbug C.diff. over the standard of care medicine.

The additional data on Summit’s ridinilazole versus vancomycin comes from the from the Phase 2 CoDIFy trial and will be heard at the 26th European Congress of Clinical Microbiology and Infectious Diseases Conference  (ECCMID).

(ECCMID 2016  Will be hosted in Amsterdam from 9 – 12 April )

Taking the antibiotic ridinilazole resulted in a marked reduction in rates of C. diff. (CDI) recurrence as compared to vancomycin (14.3% versus 34.8%) the drug discovery firm will say.

This result comes on top of t previously reported statistical superiority in ‘sustained clinical response’ rates of ridinilazole over vancomycin (66.7% compared to 42.4%) for treating the disease.

Sustained clinical response is defined as clinical cure at the end of treatment and no recurrence of the condition in 30 days after therapy.

C. diff is a serious threat in hospitals and care homes and there are between 450000 and 700000 cases in the US annually.

Recurrence is a key problem as repeat episodes are typically more severe and associated with an increase in mortality rates and healthcare costs.

 

 

To read the total article, click on the following link:

http://www.menafn.com/1094678222/Summit-Therapeutics-to-present-further-data-showing-ridinilazoles-superiority

*Please note – The C Diff Foundation does not endorse this product or any product and this posting is strictly for informational purposes only.

 

 

 

C. difficile (CDI) Treatment Summit Therapeutics Has Reported Outstanding Results In the Phase II Trial of Ridinilazole

Summit Therapeutics  has reported ‘outstanding’ results in the phase II trial of ridinilazole, its new C.difficile (CDI) treatment.

During the trial, the new oral antibiotic significantly outperformed vancomycin, the current standard prescription, which was the primary objective said Summit.

Over two-thirds (66.7%) of those treated showed a sustained clinical response (SCR) against 42.4% for vancomycin.

The statistical superiority was driven by a large numerical reduction in recurrent disease compared with vancomycin, which Summit said was key as recurrence is one of the hardest things to stop.

C.difficile or CDI is a growing danger for patients in hospital, care homes and the wider community.

Annually, there are between 450,000 and 700,000 cases in the US alone, with the elderly and sick especially vulnerable.

One study has suggested it costs US$4.8bn to treat these people.

“The healthcare community is acutely aware of the major threat CDI poses, particularly given widespread antibiotic use and our aging population,” said Glyn Edwards, Summit’s chief executive.

The biggest unmet need in CDI treatment is reduce recurring cases, he added and the results from the latest trial had exceeded its ‘wildest expectations’.

“These outstanding clinical data from CoDIFy strongly support the profile of ridinilazole as a narrow spectrum antibiotic.

“There is a vital need for potent new antibiotics, and the potential of ridinilazole has attracted great interest.

Edwards added that the results from the CoDIFy trial were exceptionally encouraging and the aim no is to advance ridinilazole into Phase 3 clinical trials.

Here, the company would evaluate partnership opportunities against the benefit of it forward itself, he added.

Professor Mark Wilcox, at Leeds University and Public Health England’s lead consultant on C.difficile added that the latest data indicated ridinilazole could become an important new treatment option for CDI with the potential to reduce the high rates of recurrent disease that remain a key clinical challenge.

CoDIFy was a double blind, randomised, active controlled, multicentre, Phase II clinical trial that evaluated the efficacy of ridinilazole against vancomycin in 100 patients in the US and Canada.

Results from a second CoFIFy trail are due next year, though Edwards said the results announced today would provide the bulk of the quantitative data.

Ridinilazole has already received Qualified Infectious Disease Product, or QIDP, designation and has been granted Fast Track status from the US Food and Drug Administration

 

*Please note – The C Diff Foundation does not endorse this product or any product and this posting is strictly for informational purposes only.