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July 20, 2021: Prevent CDI: Boost Immunity, Restore Microbiome, Replace the Bug
Neil Clark, Chief Executive Officer, Destiny Pharma, PLC
Mr. Clark qualified as an accountant with PwC in Cambridge, UK and worked for over ten years on a variety of national and international assignments in audit, corporate finance and consultancy. In 1997, Mr Clark joined CeNeS Pharmaceuticals plc, a venture capital backed private UK biotech company. Following the successful flotation of CeNeS in 1999, he was appointed CFO. In 2005, he became CEO and led the company through to its sale in 2008. He then joined Ergomed in January 2009 and was CFO during its IPO in July 2014. Mr. Clark joined Destiny Pharma as CEO in early 2017. Mr. Clark is a Fellow of the Institute of Chartered Accountants in England and Wales and has a BSc in Bioscience from the University of Nottingham.
Dale Gerding, MD, FACP, FIDSA, FSHEA
Dr. Dale Gerding is Research Physician at the Edward Hines Jr. VA Hospital and Professor of Medicine (Retired) at Loyola University Chicago Stritch School of Medicine. He is an infectious diseases specialist and hospital epidemiologist, past president of the Society for Healthcare Epidemiology of America. He is a fellow of the Infectious Diseases Society of America, is a Master of the American College of Physicians and the 2013 recipient of the William Middleton Award, the highest research award given by the Department of Veterans Affairs. He is board certified in Internal Medicine and Infectious Diseases. His major research interest is in the epidemiology, prevention and treatment of Clostridioides difficile infection and he is the discoverer of non-toxigenic C. difficile strain M3. (NTCD-M3)
Neil Clark, Chief Executive Officer, Destiny Pharma PLC and Dale Gerding, MD, FACP, FIDSA, FSHEA, with our Guest Host: Kevin Hersh, shared a robust discussion which touched upon important topics focused on the what, why, and how to Prevent a C. diff. infection: Boost Immunity, Restore Microbiome, Replace the Bug. Our guests exchanged a dialogue about the science to answer the many questions about a C. difficile infection, prevention, treatments, what is recurrent C. diff., and the immune system, and how the microbiome plays a part in everything. Click on the link provided above to access the archived episode and expand your basic CDI knowledge today.
Scientific Advisor Prof Dale Gerding to chair C. diff. Foundation
C. diff. Patient, Family, and Caregiver Symposium
July 16th – Live-Online beginning at 1:00 p.m. – 3:00 p.m. EDT
Brighton, United Kingdom – 02 July 2021 – Destiny Pharma plc (AIM: DEST), a clinical stage innovative biotechnology company focused on the development of novel medicines to prevent life-threatening infections, is pleased to announce that its Scientific Advisory Board member, Professor Dale Gerding, a world-leading expert in C. difficile infections (CDI) and the discoverer of NTCD-M3, will be chairing the “C. diff. Patient, Family, and Caregiver” Symposium, to be held virtually on 16 July 2021.
The Symposium, hosted by the C Diff Foundation, will be a gathering of healthcare professionals, practitioners, thought leaders, and C. diff. survivors focused on transforming the patient experience of people living with C. diff. infections worldwide.
Distinguished members and keynote speakers will provide insight on how to identify, evaluate, and prioritize innovations that can quickly touch the lives of patients battling C. diff. infections.
Destiny Pharma’s late-stage asset, NTCD-M3, is a novel microbiome therapeutic being developed to reduce the recurrence of C. diff. infections in the gut. CDI is the leading cause of hospital acquired infection in the US and current treatments lead to significant recurrence. In the US, there are approximately 500,000 cases of CDI each year; many of these initial cases then recur leading to 29,000 deaths per year.
NTCD-M3 has the potential to become the leading treatment for CDI, as it has shown to deliver clear advantages to both existing CDI treatment options and also to those currently in clinical development.
About Destiny Pharma plc Destiny Pharma is a UK based, clinical stage, innovative biotechnology company focused on the development of novel medicines that can prevent life-threatening infections. Its pipeline has novel microbiome-based biotherapeutics and XF drug clinical assets including NTCD-M3, a Phase 3 ready treatment for the prevention of C. difficile infection (CDI) recurrence, which is the leading cause of hospital acquired infection in the US and also XF-73 nasal gel, which has recently completed a positive Phase 2b clinical trial targeting the prevention of post-surgical staphylococcal hospital infections including MRSA. It is also co-developing SPOR-COV, a novel, biotherapeutic product for the prevention of COVID-19 and other viral respiratory infections, and has earlier grant funded XF research projects.
Update on the recently acquired NTCD-M3 biotherapeutic clinical programme for prevention of recurrence of C. difficile infections
Press release by Destiny Pharma:
Brighton, United Kingdom – 22 December 2020: Destiny Pharma plc (AIM: DEST) a clinical-stage innovative biotechnology company focused on the development of novel medicines that can prevent life-threatening infections, announces it is making good progress with preparations for the clinical development of NTCD-M3, a Phase 3 ready biotherapeutic for the prevention of C. difficile infection (CDI) recurrence.
Following the successful fundraising of £10.4 million in November 2020 and completion of the acquisition of NTCD-M3, Destiny Pharma has commenced the work required to prepare for the Phase 3 clinical study that is scheduled to start in 2022.
Also, Professor Dale Gerding has joined Destiny Pharma’s Scientific Advisory Board (SAB) and is working as a key consultant. His world-leading expertise in C. difficile infections and many years of research and clinical work on NTCD-M3 will be invaluable and he is an important addition to our team.
Destiny Pharma has also signed a major new contract with a leading biotherapeutics manufacturing company for the establishment of a new NTCD-M3 process for the production of the Phase 3 clinical trial doses. Establishing the new manufacturer will deliver a more efficient process and a lower-cost product and is an important investment in the overall NTCD-M3 project. The Company is also starting business development efforts and will reach out to potential commercial partners and grant funding bodies to raise awareness of the re-activated NTCD-M3 clinical programme.
In the US, there are approximately 500,000 cases of CDI each year; around 25% of these initial cases then recur leading to 29,000 deaths per year. Current CDI treatment options are limited with lower efficacy observed when patients are retreated with the same antibiotic for recurrence of CDI. The extra costs of care in the US per CDI patient range from $10,000 to $20,000 and the total annual CDI-attributable cost in the US alone is estimated in 2016 at $6.3 billion.
Dr. Bill Love, Chief Scientific Officer of Destiny Pharma, said, “We are very pleased to have started activities immediately on our new NTCD-M3 project. Setting up the new manufacturing process is a key step to deliver the doses of NTCD-M3 product required for the single, 800 patient Phase 3 study required by the US FDA. The work will also look at scaling up the process towards commercial supply. We look forward to announcing further progress in 2021.”
Professor Dale Gerding, the discoverer of NTCD-M3, and member of Destiny Pharma’s SAB, added: “I am enthusiastic about the resumption of the final phase of development of NTCD-M3 and welcome the opportunity to work with Destiny Pharma to bring it to patients. As a C. difficile clinician and researcher for nearly 40 years, my mission has been to see this terrible infection prevented. Everything that has been done to date suggests that NTCD-M3 will provide the preventive strategy needed to not only prevent recurrence of C. difficile infection but to also prevent it from ever occurring in the most vulnerable patients.”
Destiny Pharma plc
Neil Clark (Chief Executive Officer)
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NTCD-M3 (non-toxigenic C. difficile strain M3) was developed by the US infectious diseases physician, Professor Dale Gerding, who is a world-leading specialist in C. difficile infection, with more than 400 peer-reviewed journal publications, book chapters, and review articles in the area. NTCD-M3 has successfully completed Phase 1 and Phase 2b trials. The Phase 1 study demonstrated a strong safety/toxicology profile and Phase 2b showed that the best dose delivered a 95% prevention of CDI recurrence. The Phase 2b NTCD-M3 data was published in the prestigious Journal of the American Medical Association (Gerding DN et al JAMA
C. difficile NTCD-M3 is a naturally occurring non-toxigenic strain of C. difficile bacteria, which lacks the genes that can express C. difficile toxins. It is an oral formulation of NTCD-M3 spores and patients who have taken NTCD-M3 were found to be protected from recurrence of C. difficile infections. NTCD-M3 acts as a safe “ground cover” preventing toxic strains of C. difficile proliferating in the colon after antibiotic treatment. NTCD-M3 temporarily colonizes the human gut without causing any symptoms allowing the gut microbiome time to recover following antibiotic treatment.
About Destiny Pharma
Destiny Pharma is a clinical-stage, innovative biotechnology company focused on the development of novel medicines that can prevent life-threatening infections. Its pipeline has novel microbiome-based biotherapeutics and XF drug clinical assets including NTCD-M3, a Phase 3 ready treatment for the prevention of C. difficile infection (CDI) recurrence which is the leading cause of hospital-acquired infection in the US, and also XF-73 nasal gel, which is in a Phase 2b clinical trial targeting the prevention of postsurgical Staphylococcal hospital infections including MRSA. It is also co-developing SPOR-COV, a novel, biotherapeutic product for the prevention of COVID-19 and other viral respiratory infections, and has earlier grant-funded XF research projects.