Destiny Pharma and US Department of Veterans Affairs enter into Cooperative Research and Development Agreement to further research NTCD-M3 for prevention of recurrence of Clostridioides difficile infections

Brighton, United Kingdom, 6 July 2021 – Destiny Pharma plc (AIM: DEST), a clinical stage innovative biotechnology company focused on the development of novel medicines that can prevent life threatening infections, is pleased to announce a Cooperative R&D agreement with the US Department of Veterans Affairs to support studies focusing on identifying new attributes for NTCD-M3, a novel microbiome therapeutic being developed to reduce the recurrence of Clostridioides difficile infections (CDI) in the gut.

Destiny Pharma will collaborate on this research project with the Edward Hines Jr. VA Hospital in Hines, Illinois, utilising their CDI research expertise to complete new preclinical studies that could support the administration of NTCD-M3 to a broader CDI patient population and therefore strengthen the market opportunity. The research project is planned to complete in Q4 2021. Financial terms are not disclosed.

Stuart Johnson, MD Professor of Medicine, Loyola Stritch School of Medicine, will lead the team conducting further studies of NTCD-M3 at the Edward Hines, Jr. VA Hospital, which has long been recognised for its advanced research into the diagnosis, epidemiology, prevention and treatment of CDI.

According to Prof. Johnson, “The potential for prevention of CDI with this non-toxigenic strain of C. difficile has been well-established. However, the mechanism of this protective effect has not been fully established. We are poised to conduct experiments that will help delineate the factors whereby NTCD-M3 prevents infection with toxigenic strains of this ubiquitous pathogen.”

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 prevention, as its Phase 2 data demonstrated a class leading 5% rate of recurrence compared to 30% with placebo.

The benefits of NTCD-M3 include:

• Single bacterial strain: a naturally occurring, single strain of a non-toxigenic bacteria;
• Excellent safety profile: well-defined treatment;
• Strong clinical data: NTCD-M3 recurrence rate of 5% versus 30% with placebo, which is “class leading”;
• Convenient treatment option: it is complementary to all current standard of care antibiotic treatments, administered as a single capsule once daily for seven days;
• Well-established manufacturing: will be manufactured at high volume and low cost with a long shelf life which should enable high uptake and a strong pharmacoeconomic position.

Destiny Pharma is progressing the plans for the single Phase 3 clinical study, the design of which has already been discussed with the US FDA, and which needs to be completed before submitting marketing authorisation applications in the US and Europe. The Phase 3 clinical study remains on schedule to commence in 2022.

Destiny Pharma has also commenced discussions with potential licensing partners and collaborators and is encouraged by the level of interest in the programme. The aim is to secure a partner to support the planned Phase 3 clinical study and participate in the future commercial launch of NTCD-M3.

Neil Clark, Chief Executive Officer of Destiny Pharma, said: “We are very pleased to be working with the expert CDI team at the Edward Hines, Jr. VA Hospital in Chicago. The planned study will help Destiny Pharma refine our planning for the NTCD-M3 Phase 3 study that we aim to start in 2022. There is a significant clinical and commercial opportunity for NTCD-M3 as a novel treatment to prevent the recurrence of CDI.”