Targeting peak sales potential of $1 billion in the major markets
Brighton, United Kingdom – 07 December 2022 – 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 that it has now finalised plans for its Phase 3 studies for its late-stage clinical asset, XF-73 Nasal.
Highlights
- Discussions held with US and EU Regulators and Clinical Key Opinion Leaders
- Proposing two Phase 3 studies in two major surgery types to aim to provide a broad surgery label for XF-73 Nasal
- Phase 3 programme will deliver an approvable data package for both US and EU authorities
- XF-73 Nasal targeting peak sales potential of $1 billion in its major target markets
- Phase 3 patient recruitment could start in 2024 subject to completing an XF-73 Nasal partnering deal in 2023
XF-73 Nasal is the lead drug candidate developed from Destiny Pharma’s XF platform and it is initially being developed for the prevention of post-surgical staphylococcal infections, such as methicillin-resistant Staphylococcus aureus (MRSA), which can cause significant complications and increased healthcare costs in the hospital setting.
The aim of the announced Phase 3 clinical programme is to deliver comprehensive clinical trial data demonstrating that nasal decolonisation using XF-73 Nasal, alongside “standard of care”, reduces the incidence of post-surgical infections in patients. This meets the requirements of both the US and EU regulators – the FDA and EMA.
After a detailed review, the Company has decided that the Phase 3 programme should consist of two Phase 3 studies including patients in two well-defined surgery models. One study will be in breast surgery as a model for general surgery and the other will be in expedited orthopedic surgery as a model of orthopedic surgery.
This Phase 3 programme is expected to include up to 2,000 patients and deliver a comprehensive data set supporting a clinical endpoint in Surgical Site Infection (“SSI”) reduction that is clinically and statistically significant. Successful clinical studies will therefore provide Destiny Pharma with a broad surgery label for its XF-73 Nasal gel thereby expanding product sales targets and maximizing the commercial opportunity. Post-surgical infections create a significant healthcare burden on hospitals and healthcare systems costing $10 billion per year in the US. A single MRSA post-surgical infection costs over $160,000 to treat and adds 15 days onto a hospital stay.
In parallel, Destiny Pharma is considering two additional indications for XF-73 Nasal in oncology patients and in community acquired infections. These extra Phase 3 studies would provide supportive data and life cycle management opportunities for XF-73.
Having clarified the Phase 3 study designs, the Company is now expanding its partnering activities on XF-73 Nasal with the aim of securing a deal in 2023.
Dr Yuri Martina, Chief Medical Officer of Destiny Pharma, said: “Having finalized our Phase 3 strategy for our primary indication of SSI prevention, we are ready for the next steps in executing our well-defined and validated strategy. I am excited to see this compound approaching its final clinical trials and moving toward market approval. If successful, XF-73 Nasal will deliver a much needed, novel treatment to help prevent surgical site infections through nasal decolonisation, which is best practice in hospitals across the world and an important unmet medical need for certain patient populations and surgeries.”
Neil Clark, Chief Executive Officer of Destiny Pharma, added: “There is a significant, billion-dollar, potential global commercial opportunity for XF-73 Nasal gel to help prevent hospital infections and to effectively decolonise patients undergoing a wide range of medical treatments. In line with our strategy for 2022, the clinical team has completed an extensive review, spoken with key regulators and finalized our Phase 3 development plans for XF-73 Nasal. While we gear up for the next steps, we are actively seeking a partner to join us in executing the Phase 3 Development plans and lead the commercialization of this exciting new medicine.”
Full Press Release available here.