- 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 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).
Full Press Release available here.