Destiny Pharma plc
(“Destiny Pharma” or “the Company”)
Positive update on microbiome therapeutic NTCD-M3 for recurrent C. difficile infections
· Preparations for Phase 3 study progressing to plan
· Established world leading clinical advisory board
· Partnering discussions ongoing
Brighton, United Kingdom – 2nd June 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 positive progress with its lead clinical programme, NTCD-M3.
NTCD-M3 is a novel microbiome therapeutic being developed to reduce the recurrence of C. difficile infections (CDI) 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 appears to deliver clear advantages to both existing CDI treatment options and also to those currently in clinical development.
The benefits of NTCD-M3 include:
· Single bacterial strain: a naturally occurring, single strain of a non-toxigenic bacteria
· Good safety: well-defined treatment
· Strong clinical data: CDI recurrence rate for NTCD-M3 treated patients with the best dose in previous Phase 2 trial of only 5% is “class leading”
· Convenient treatment option: can be taken alongside all current standard of care antibiotic treatments as a single capsule taken 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
· Fast Track designation by the FDA
Destiny Pharma is progressing the planning for the single Phase 3 clinical study that 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.
Key development and manufacturing activities undertaken to date include:
· Completed the technology transfer of information into the new contract drug manufacturing organisation (CDMO) that will produce NTCD-M3 in its specialised biotherapeutic fermentation plant
· Completed the set-up of key analytical viability methods that will be used to assess the quality and purity of the spores of NTCD-M3 produced in the manufacturing process
· Initiated process development work on fermentation to achieve a high and reproducible NTCD-M3 concentration
· Preliminary work underway to define a matrix and method of drying to isolate NTCD-M3 within a solid matrix for formulation as an easy to use, stable, oral capsule
Clinical trial planning is progressing well and activities already underway include:
· Establishment of a NTCD-M3 clinical advisory board consisting of Professor Dale Gerding MD US, who discovered NTCD-M3, Professor Mark Wilcox MD, UK key opinion leader in CDI and other medical and drug development experts with recent experience of running and designing international Phase 3 clinical studies in CDI
· Initiated the supplier selection of a clinical trial organisation (CRO) for the Phase 3 study
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 help fund the planned Phase 3 clinical study and participate in the future commercial launch of NTCD-M3.
Neil Clark, Chief Executive Officer of Destiny Pharma, commented:
“We have made significant progress since closing the £10.4 million equity funding in December 2020 that enabled the NTCD-M3 acquisition. NTCD-M3 is a potential breakthrough in CDI treatment targeting a market that is forecast to grow to $1.7 billion by 2026 and is a very valuable, late-stage asset. We look forward to making further progress this year and to finalising the Phase 3 study design and manufacturing set up.”
For further information, please contact:
Destiny Pharma plc
Neil Clark, CEO
Shaun Claydon, CFO
+44 (0) 127 370 4440
Optimum Strategic Communications
Mary Clark/ Shabnam Bashir/ Manel Mateus
+44 (0) 203 174 1789
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 / Nigel Birks
+44 (0) 203 705 9330
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 on the company, please visit www.destinypharma.com