Destiny Pharma (DEST ), a clinical stage biotechnology company, said it has finalised plans for Phase 3 studies of its late-stage clinical asset XF-73 Nasal.
XF-73 Nasal is a drug candidate developed from Destiny's XF platform, initially being developed for for the prevention of post-surgical staphylococcal infections, such as MRSA.
The Phase 3 programme aims 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 FDA and EU EMA regulators.
Destiny said it decided after a detailed review, that the Phase 3 programme should consist of two studies including patients in two 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.
Overall, the 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 inflection (SSI) reduction that is clinically and statistically significant. Successful clinical studies will therefore provide Destiny with a broad surgery label for XF-73 Nasal, maximising its commercial opportunity.
In parallel, Destiny is considering two additional indications for XF-73 Nasal in oncology patients and in community acquired infections. These extra Phase studies would provide "supportive data and life cycle management opportunities for XF-73", Destiny explained.
Neil Clark, CEO, commented: "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."
Dr. Yuri Martina, Chief Medical Officer, commented: "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 move 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."
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Destiny has now finalised its Phase 3 development programme for XF-73 Nasal. After discussions with the US FDA and EU EMA, Destiny has proposed studies in two major surgery types (breast cancer and orthopedic surgery) to provide a broad surgery label for XF-73 Nasal, targeting a peak sales potential of US$1bn in its major markets.
The Phase 3 programme will deliver an approvable data package for the US and EU authorities with recruitment due to start in 2024, data potentially available in 2025, and filings for approval expected in 2026.
Before that, Destiny is targeting a partnering deal for Phase 3 development and commercialisation of XF-73 Nasal, planned for 2023.
Investors should pay attention to the XF-73 Nasal Phase 3 development timeline as it contains significant value inflection points for Destiny Pharma. DEST shares are up 3% on today's announcement as of time of writing.
XF-73 Nasal aims to address a significant unmet clinical need. Post-surgical infections create a considerable healthcare burden on hospitals and healthcare systems, costing US$10bn per year in the US. A single MRSA post-surgical infection costs over US$160K to treat and adds 15 days to a hospital stay.
Destiny Pharma is also finalising preparation for a Phase 3 clinical trial of its NTCD-M3 treatment for prevention of C. difficile infection (CDI) recurrence. There are 500,000 annual cases of CDI in the US alone, leading to 29,000 deaths per year. With limited treatment options, CDI instances result in c. US$6bn in annual healthcare costs in the US. Peak global sales of NTCD-M3 have therefore been estimated at US$1bn a year.
Destiny Pharma's two late-stage clinical assets present strong potential for future revenue as the market for infectious and respiratory disease prevention and treatment continues to grow. Both NTCD-M3 and XF-73 are supported by strong Phase 2 clinical data and address clear clinical needs with significant commercial opportunities.
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