26 July 2022 – Publication of new data on NTCD-M3

Destiny Pharma plc

(“Destiny Pharma” or “the Company”)

Publication of new data on NTCD-M3 confirms potential as an effective treatment for prevention of C. difficile infections

Brighton, United Kingdom – 26 July 2022 – Destiny Pharma plc (AIM: DEST), a clinical stage biotechnology company focused on the development of novel products to prevent life-threatening infections, today announces publication of new data on NTCD-M3, its novel treatment for the prevention of C. difficile infection (CDI) recurrence, in the peer reviewed journal  Public Library of Science One (PLOS ONE):  Absence of toxin gene transfer from Clostridioides difficile strain 630Δerm to nontoxigenic C. difficile strain NTCD-M3r in filter mating experiments | PLOS ONE).

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.

The study, carried out by Professor Dale Gerding and his team at the VA Hines laboratories (US), examined in vitro the potential for the transfer of the gene responsible for toxin production from a toxigenic strain of C. difficile to NTCD-M3. Such a transfer would be undesirable as it is the toxins produced that are responsible for causing serious gut irritation and major life-threatening symptoms of this common hospital gut infection.

The study demonstrated that attempted conjugations using a toxigenic C. difficile strain (630∆erm) as a gene donor, failed to show toxin gene transfer to NTCD-M3 but confirmed transfer to a different NTCD strain, namely CD37, which had previously been reported (Brouwer MSM, Roberts AP, Hussain H, Williams RJ, Allan E, Mullany P. Horizontal gene transfer converts non-toxigenic Clostridium difficile strains into toxin producers. Nat Commun. 2013;4: 2601 doi: 10.1038/ncomms3601. pmid:24131955).

Destiny Pharma is currently finalising preparations for the pivotal Phase 3 clinical trial of NTCD-M3 and seeking partners to help co-fund studies and lead commercialisation of this exciting biotherapeutic product. NTCD-M3 has previously reported very good Phase 2 clinical trial results.

Dr Bill Love, Chief Scientific Officer of Destiny Pharma, said: “This is an important finding for NTCD-M3 as it demonstrates the inability for the transfer of the genes which encode for toxin production into our novel biotherapeutic product. This gives us additional confidence that such transfer will not occur clinically and supports our view that NTCD-M3 will deliver an effective and safe treatment to the many thousands of patients who experience a C. difficile infection”.

Professor Dale Gerding, Scientific Advisory Board Member of Destiny Pharma, added: The transfer of the pathogenicity locus (PaLoc) which contains the toxin genes of toxigenic C difficile, has been found to occur in laboratory experiments with certain strains of C. difficile. We were unable to demonstrate this transfer to NTCD-M3 in multiple laboratory attempts, suggesting that NTCD-M3 possesses mechanisms that resist such transfer. More importantly, such transfers have never been observed in animal models or humans treated with NTCD-M3, indicating that PaLoc transfer is highly unlikely to occur in clinical practice”.

Dale N. Gerding, MD MACP FIDSA FSHEA

Dr Dale Gerding is a Professor of Medicine in the Division of Infectious Diseases at Loyola University Chicago Stritch School of Medicine, Maywood, IL (retired) and Research Physician at the Edward Hines Jr. Veterans Affairs Hospital, Hines, IL where he maintains his active research laboratory. He is board certified in internal medicine and infectious diseases and a Master of the American College of Physicians and a member of the American Society for Microbiology. Dr Gerding discovered and developed the NTCD-M3 preventive treatment for C. difficile through its Phase 2 programme.

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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 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-COVTM, a novel, biotherapeutic product for the prevention of COVID-19 and other viral respiratory infections and has earlier grant funded XF drug research projects.

For further information on the company, please visit www.destinypharma.com

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