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 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.”
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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 the 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.
For further information, please visit https://www.destinypharma.com