Destiny Pharma. Regulatory News (DEST)

Destiny Pharma plc

("Destiny Pharma" or "the Company")

Significant clinical and commercial opportunity of NTCD-M3 confirmed by positive data from US research study and new market research

· US Department of Veterans Affairs study confirms the potential of NTCD-M3 as a novel treatment to prevent the recurrence of CDI that can be used alongside all standard-of-care antibiotic treatments

· US and European market research underpins clinical support and market opportunity

Brighton, United Kingdom, 24 January 2022 - Destiny Pharma plc (AIM: DEST), a clinical stage innovative biotechnology company focused on the development of novel medicines that can prevent life threatening infections, today announces the successful outcome of the Cooperative R&D agreement with the US Department of Veterans Affairs with NTCD-M3, a novel microbiome therapeutic being developed to reduce the recurrence of Clostridioides difficile infections (CDI) in the gut. The research results confirmed NTCD-M3's ability to colonise the gut after antibiotic administration, which strengthens the market opportunity as it supports its use following commonly used antibiotic treatments. The Company also announces findings from North American and European market research which reinforce the clinical support and market potential of NTCD-M3.

Oral antibiotics kill beneficial bacteria in the gut, causing unintentional and harmful collateral damage. This allows Clostridioides difficile to grow in the gut and release toxins which cause disease. 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. It is estimated that CDIs result in an additional US$6 billion in healthcare costs per year in the US alone. Destiny Pharma's late‑stage asset NTCD-M3, which has already completed successful Phase 2 clinical trials, has been shown to prevent recurrence following the normal standard-of-care antibiotic treatment with only a 5% recurrence rate - the Company believes this is the biggest reported reduction in CDI recurrence from clinical studies.

Some antibiotics used for the treatment of CDI, including fidaxomicin (Dificid®), can remain in the gut for a prolonged period after treatment, potentially impacting the ability of NTCD-M3 to colonise and prevent infection recurrence. The US Department of Veterans Affairs conducted a preclinical study using the best accepted CDI research model. The study demonstrated successful (100%) gut colonisation of NTCD-M3 following treatment with fidaxomicin (Dificid®). In addition, successful (100%) NTCD-M3 gut colonisation was also demonstrated following pre-treatment with vancomycin, the most commonly used first-line antibiotic treatment for CDI. These results provide further support and rationale for the use of NTCD-M3 as an adjunct to both current standard-of-care treatments, vancomycin and fidaxomicin, for the prevention of CDI recurrence.

Neil Clark, Chief Executive Officer of Destiny Pharma, said: "We are very pleased with the outcome of our collaboration with the expert CDI team at the Edward Hines, Jr. VA Hospital. We are encouraged by these latest findings that support the administration of NTCD-M3 to the broadest CDI patient population receiving any approved antibiotic treatment and strengthens our planning for the NTCD-M3 Phase 3 study, which we aim to start later this year. The market research further supports these findings and will be invaluable in helping to position NTCD-M3 for the prevention of CDI, as well as development and commercial considerations critical to determining the product's market potential. There is significant value potential in our NTCD-M3 asset, and we look forward to providing further updates on the regulatory and development plans throughout 2022."

Destiny Pharma collaborated on this research project with the Edward Hines, Jr. VA Hospital in Hines, Illinois, which has long been recognized for its advanced research into the diagnosis, epidemiology, prevention, and treatment of CDI.

Stuart Johnson, M.D. Professor of Medicine, Loyola Stritch School of Medicine who leads the team at the Edward Hines, Jr. VA Hospital, said: "These results provide support and rationale for the use of NTCD-M3 as an adjunct to both current standard of care treatments, vancomycin and fidaxomicin, for the prevention of recurrence of CDI."

North American and European market research has also been completed to understand the commercial implications of the clinical and market access landscape in CDI for NTCD-M3. Interviews were conducted with High-Volume Prescribers (HVPs) and reimbursement experts across the US and Europe. The findings provide powerful external validation for Destiny Pharma's product NTCD-M3 from clinicians and payers in both the US and Europe.

Key findings from the market research include:

1. Physicians were very optimistic about NTCD-M3's potential given the very low recurrence rate of 5% seen in the Phase 2 study, its mechanism of action, and safety profile. NTCD-M3 has low cost of goods, long shelf life, and if it can replicate the 5% recurrence rate in a Phase 3 study, would be much more efficacious in preventing recurrence when compared to products in development and on the market. A simple administration profile of one capsule per day for 7 days to achieve colonisation was also seen as beneficial over the competitors.

2. There is significant interest in using the product to prevent recurrence after a primary episode (a first infection) and first recurrence (those who have had a first infection and then subsequently a recurrence) patients. These are patient groups with significant medical need and where it is necessary to disrupt the recurrence escalator early on before patients get into a terrible cycle of cure and recurrence which leads to increased morbidity and increased mortality. 

3. Taking all the benefits together including cost and ease of use, the clinicians could see significant benefit of NTCD-M3's approach over FMT (Faecal Microbiota Transplant) or bacterial consortia products. Payers in both the US and EU anticipate strong reimbursement potential given NTCD-M3's profile and at a price to encourage uptake in the primary episode and first recurrence patients. They could see the benefit of using the product early to reduce the cycle of recurrence and in turn reduce the significant healthcare burden managing this infection places on hospitals and healthcare systems.

ENDS

For further information, please contact:

Destiny Pharma plc

Neil Clark, CEO

Shaun Claydon, CFO

pressoffice@destinypharma.com 

+44 (0)1273 704 440

Optimum Strategic Communications

Mary Clark, Manel Mateus, Vici Rabbetts

DestinyPharma@optimumcomms.com 

+44 (0) 208 078 4357

www.optimumcomms.com

finnCap Ltd (Nominated Advisor Joint Broker)

Geoff Nash / Kate Bannatyne, Corporate Finance

Alice Lane, Corporate Broking

+44 (0) 207 220 0500

WG Partners (Joint Broker)

Nigel Barnes / Claes Spång/Satheesh Nadarajah

+44 (0) 203 705 9330

MC Services AG

Anne Hennecke / Andreas Burckhardt

+49-211-529252-0

Notes to Editors

About NTCD-M3

NTCD-M3 is a novel microbiome therapeutic being developed to reduce the recurrence of C. difficile 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 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: 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

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-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 www.destinypharma.com

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