RCS - Destiny Pharma PLC - Positive findings from recent SAB meeting

Destiny PharmaAnnouncement

06/07/2023 07:00

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RNS Number : 1054F  Destiny Pharma PLC  06 July 2023

Destiny Pharma plc

("Destiny Pharma" or "the Company")

 

Positive findings from recent Scientific Advisory Board meeting

Confirms proposed Phase 3 development pathway and identifies new life cycle
management targets for XF-73 Nasal

 

Brighton, United Kingdom - 6 July 2023 - Destiny Pharma (AIM: DEST), a
clinical stage biotechnology company focused on the development and
commercialisation of novel medicines to prevent life threatening infections,
recently held a meeting with its Scientific Advisory Board and a number of
international experts from the UK and US focused on the XF-73 Nasal
development programme.

The panel of surgeons and infectious disease experts concluded that:

·    The proposed XF-73 Nasal programme, consisting of two
placebo-controlled surgical phase 3 studies with a clinical endpoint, designed
around FDA input, reflects the utility of XF-73 Nasal in all surgeries.

·    The rapid antimicrobial action of XF-73 Nasal gives greater
flexibility in the scheduling of surgeries than existing offerings and
provides direct value to patients and institutions.

·    Antimicrobial resistance remains of global importance, with S. aureus
and resistant strains such as MRSA and MupRSA of great concern clinically.
XF-73 Nasal, through its unique and rapid mechanism of action, can play an
important role in antibiotic stewardship by reducing the need for post-op
systemic antibiotics. Additionally, XF-73 Nasal could prevent horizontal
transmission of S. aureus, thus further contributing to good antibiotic
stewardship.

·    New potential life cycle management indications are available for
Destiny to explore, particularly in children (and their families), where there
are concerns over the use of mupirocin and antiseptic approaches and a high
unmet medical need remains.

 

Dr. Raghbir Khakha, Consultant Orthopaedic & Specialist Knee Surgeon.
Guy's and St Thomas', London, said: "XF-73 Nasal's fast action and the
consequent proposed dosing are a great advantage to patients and institutions,
as it can be used in emergency cases and avoids rescheduling appointments when
Staphylococcus aureusis discovered. In other words, XF-73 Nasal can help avoid
empty operating theatres and maximize efficiencies in hospitals across the
country."

 

Prof. Richard Proctor, Professor Emeritus of the Department of Medical
Microbiology/Immunology and Professor Emeritus of the Department of Medicine,
University of Wisconsin School of Medicine and Public Health Madison,
Wisconsin, said: "Destiny's Phase 3 programme is designed to provide the FDA
with the evidence they need on clinical efficacy in infection prevention
across a wide range of surgeries. In addition, it is important that Destiny
continues to collect the microbiological data, as it has done in the phase 2
cardiac surgery study, to confirm efficacy against all circulating strains of
Staphylococcus aureus, including MRSA and mupirocin resistant strains, and to
confirm the lack of development of resistance on treatment. Completion of
these studies should demonstrate that XF-73 Nasal has an important role to
play as part of antibiotic stewardship in hospitals and the community."

 

Dr. Debra Barker, Interim Chief Executive Officer of Destiny Pharma, said:
"This thought-provoking meeting has confirmed Destiny Pharma is on the right
path and that XF-73 Nasal provides a much-needed addition to the armory
against AMR and surgical site infections."

 

Destiny Pharma has recently completed detailed interactions with the
regulators
(https://www.destinypharma.com/2022/12/07/7-december-2022-xf-73-nasal-phase-3-development-plans-finalised/)
and identified options for the final Phase 3 clinical development stage to
obtain approval for the XF-73 Nasal gel product in the US and Europe. The
Company is actively seeking partners for the XF-73 Nasal programme.

 

The following international experts participated in the meeting:

·    Prof. E. Patchen Dellinger, Associate Medical Director, University of
Washington Medical Center

·    Dr. Raghbir Khakha, Consultant Orthopaedic & Specialist Knee
Surgeon. Guy's and St Thomas', London

·    Prof. Julie Mangino, Professor Emeritus, Department of Internal
Medicine, Division of Infectious Diseases, The Ohio State University

·    Dr. Alexander Mericli, Associate Professor of Plastic Surgery. The
University of Texas, MD Anderson Cancer Center

·    Prof. Leonard Mermel, Professor of Medicine, Warren Alpert Medical
School of Brown University, Adjunct Clinical Professor, University of Rhode
Island College of Pharmacy and Medical Director of the Department of
Epidemiology & Infection Control for the Lifespan Hospital System

·    Prof. Richard Proctor, Professor Emeritus of the Department of
Medical Microbiology/Immunology and Professor Emeritus of the Department of
Medicine, University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin

·    Prof. David Roblin, Chair of Scientific Translation at The Francis
Crick Institute and Chair of Destiny Pharma SAB

·    Prof. Mark Wilcox, Consultant microbiologist, Head of Research and
Development in Microbiology, Leeds Teaching Hospitals (LTHT)

Destiny Pharma representatives included Dr. Debra Barker (CEO), Dr. Yuri
Martina (CMO) and Dr. William Love (CSO).

 

 

- END -

For further information, please contact:

 

Destiny Pharma plc
Debra Barker, CEO

Shaun Claydon, CFO

+44 (0)1273 704 440
pressoffice@destinypharma.com (mailto:pressoffice@destinypharma.com)

 

Optimum Strategic Communications
Mary Clark / Nick Bastin / Jonathan Edwards / Eleanor Cooper

+44 (0) 7931 5000 66
DestinyPharma@optimumcomms.com (mailto:destinypharma@optimumcomms.com)

 

finnCap Ltd (Nominated Advisor and Joint Broker)
Geoff Nash / George Dollemore, Corporate Finance

Alice Lane / Nigel Birks / Harriet Ward, ECM

+44 (0) 207 220 0500

 

Shore Capital (Joint Broker)

Daniel Bush / James Thomas / Lucy Bowden

+44 (0) 207 408 4090

 

MC Services AG
Anne Hennecke / Andreas Burckhardt

+49-211-529252-12

 

 

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 2 clinical trial targeting the
prevention of post-surgical staphylococcal hospital infections including MRSA.
It is also co-developing SPOR-COV(TM), a novel, biotherapeutic product for the
prevention of COVID-19 and other viral respiratory infections and has earlier
grant funded XF drug research projects.

 

For further information on the company, please visit www.destinypharma.com
(http://www.destinypharma.com)

 

 

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