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XF-73 Patient Recruitment","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II","country":"UNITED KINGDOM","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2021","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase II"},{"orgOrder":0,"company":"Destiny Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Destiny Pharma Reports Positive Phase 2b Results for XF-73 Nasal Gel","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II","country":"UNITED KINGDOM","productType":"Small molecule","productStatus":"New Molecular Entity","date":"March 2021","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase II"},{"orgOrder":0,"company":"Destiny Pharma","sponsor":"Sebela Pharmaceuticals","pharmaFlowCategory":"D","amount":"$570.0 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Find Clinical Drug Pipeline Developments & Deals by Destiny Pharma
SPOR COV product consists of a proprietary formulation of Bacillus bacteria that is administered nasally as a spray. It is being developed for for COVID-19 and Influenza.
Under the terms of the deal, Sebela will lead the future clinical development and commercialisation activities of NTCD-M3 in North America. NTCD-M3 is a naturally occurring non-toxigenic strain of C. difficile which lacks the genes that can express C. difficile toxins.
The net proceeds of the Fundraising will allow the Company to complete final Phase 3 clinical trial preparation for NTCD-M3, Destiny pharma’s lead asset for the prevention of Clostridioides difficile infection (CDI) recurrence.
XF-73 reduced the mean nasal burden of S. aureus in patients undergoing open heart surgery by 2.5 log (CFU/ml) in the 24 hours immediately before surgery in the micro-ITT (Intend to Treat) population, a statistically highly significant result.
XF-73 is a first-in-class drug candidate from Destiny Pharma’s XF platform, initially being developed for the prevention of postsurgical staphylococcal infections, such as methicillin-resistant Staphylococcus aureus.
Destiny Pharma reported that it is making good progress with preparations for the clinical development of NTCD-M3, a Phase 3 ready biotherapeutic for the prevention of C. difficile infection (CDI) recurrence.
Under the agreement, the parties will share any costs and commercial returns from SPOR-COV and plan to complete a pre-clinical programme with the aim of being ready to enter the first human clinical trials within 18 months.
Positive interim safety review has been completed by an Independent Data Monitoring Committee (IDMC) of the Company’s ongoing Phase 2b study of its lead asset XF-73 in the prevention of post-surgical bacterial infections.
Destiny Pharma agreed with FDA to reduce Phase 2b study size without compromising its statistical power or clinical value. The study is evaluating XF-73 for the prevention of post-surgical hospital infections caused by Staphylococcus aureus
bacteria, such as MRSA.