Destiny Pharma PLC Phase 2b trial of XF-73 completes recruitment (5179K)
January 05 2021 - 1:00AM
UK Regulatory
TIDMDEST
RNS Number : 5179K
Destiny Pharma PLC
05 January 2021
Destiny Pharma plc
("Destiny Pharma" or "the Company")
Phase 2b clinical trial of XF-73 completes patient
recruitment
Results expected in Q1 2021
Brighton, United Kingdom - 5th January 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, today announces that its XF-73 Phase 2b
clinical trial was fully recruited by 31 December 2020, meeting the
target timeline set for the programme.
Neil Clark, Chief Executive Officer of Destiny Pharma, said :
"We are very pleased to have completed enrollment in our Phase 2b
clinical trial testing XF-73 nasal gel as a novel product
preventing the incidence of post-surgical infections such as MRSA.
We previously reported excellent interim safety data in mid-2020
and are now looking forward to announcing the full results of this
study and planning the Phase 3 clinical programme. There is a
global need for better treatments to prevent post-surgical
infections in hospitals as recognized in the FastTrack status
awarded to XF-73 by the US FDA. There is also a significant
commercial opportunity for XF-73 in the hospital setting which we
estimate could generate peak annual product sales of $1 billion in
the US alone.
2020 was a transformational year for Destiny Pharma as we
accelerated our strategy to build a world leading anti-infection
company with a robust pipeline. We established a
biotherapeutic/microbiome pipeline alongside our existing XF
platform and are now co- developing SPOR-COV as a novel, preventive
treatment for COVID-19. We also raised GBP10.4 million to acquire
NTCD-M3, a Phase 3 ready biotherapeutic treatment for the
prevention of C. difficile infection recurrence. The news today on
our XF-73 Phase 2b study is another major milestone for the Company
and we continue to look forward to announcing the study results in
Q1 2021."
Details of Phase 2b Trial
XF-73 is a first-in-class drug candidate from Destiny Pharma's
XF platform, initially being developed for the prevention of
post-surgical staphylococcal infections, such as
methicillin-resistant Staphylococcus aureus (MRSA), which cause
significant complications and increased healthcare costs in the
hospital setting. It has been awarded both qualifying infectious
disease product (QIDP) and Fast Track status by the US FDA. The
Phase 2b trial is a multi-centre, randomised, blinded,
placebo-controlled study of multiple applications of a single
concentration of XF-73 nasal gel to assess the microbiological
effect of XF-73 on commensal Staphylococcus aureus nasal carriage
in up to 125 patients scheduled for open heart surgery.
The Phase 2b trial design is closely related to the successful
2016 clinical trial, which was funded by the National Institute of
Allergy and Infectious Disease (part of the US National Institute
of Health) and demonstrated the efficacy of XF-73 versus placebo in
reducing Staphylococcus aureus nasal carriage in healthy
volunteers. Previous clinical and scientific data supports XF-73 as
having a novel mechanism of action and being a safe, fast and
targeted anti-infective agent. In microbiological studies it has
also shown to not generate anti-microbial resistance (AMR) and
therefore has the potential to have a clear advantage over older
antibiotic treatments that can lead to the generation of drug
resistant "superbugs".
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, Shabnam Bashir, 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 is in a 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 https://www.destinypharma.com
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