TIDMDEST
RNS Number : 4863A
Destiny Pharma PLC
02 June 2021
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 - 2(nd) 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 GBP10.4
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
pressoffice@destinypharma.com
Optimum Strategic Communications
Mary Clark/ Shabnam Bashir/ Manel Mateus
+44 (0) 203 174 1789
destinypharma@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 / 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
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
RNS may use your IP address to confirm compliance with the terms
and conditions, to analyse how you engage with the information
contained in this communication, and to share such analysis on an
anonymised basis with others as part of our commercial services.
For further information about how RNS and the London Stock Exchange
use the personal data you provide us, please see our Privacy
Policy.
END
RESUPUPAQUPGGAG
(END) Dow Jones Newswires
June 02, 2021 02:00 ET (06:00 GMT)
Destiny Pharma (LSE:DEST)
Historical Stock Chart
From Apr 2024 to May 2024
Destiny Pharma (LSE:DEST)
Historical Stock Chart
From May 2023 to May 2024