TIDMDEST
RNS Number : 2140E
Destiny Pharma PLC
06 July 2021
Destiny Pharma plc
("Destiny Pharma" or "the Company")
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."
For further information, please contact:
Destiny Pharma plc
Neil Clark, CEO
Shaun Claydon, CFO
pressoffice@destinypharma.com
+44 (0) 127 370 4440
Optimum Strategic Communications
Mary Clark/ Hollie Vile/ Manel Mateus
DestinyPharma@optimumcomms.com
+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, please visit www.destinypharma.com
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