Destiny Pharma plc
("Destiny Pharma" or "the Company")
Destiny Pharma Awarded Innovation Passport Designation by the
· Innovation Passport provides entry to the
· XF-73 Nasal is an innovative medicine developed to prevent post-surgical infections and is potent against all MRSA strains.
ILAP is unique as it aims to accelerate the time to market and facilitate patient access to medicines in the
The MHRA ILAP Steering Committee noted that XF-73 Nasal is already at a late stage of development and has a well-developed Target Development Profile which can be developed through accessing the benefits offered by the ILAP toolkit which includes recommendations from the Patient Engagement Team; clinical trial application and guidance, alongside advice and Conditional Marketing Authorisation.
Chris Tovey, Chief Executive Officer of Destiny Pharma, said: "XF-73 Nasal and its successful Innovation Passport application builds upon its already existing US FDA Qualifying Infectious Disease Product status, demonstrating the significant regulatory endorsement and recognition of XF-73 Nasal's potential in addressing the challenges of antimicrobial resistance."
Dr Bill Love, Chief Scientific Officer of Destiny Pharma added: "The clinical data underpinning the XF‑73 Nasal programme is compelling with an excellent safety profile and efficacy against a wide range of gram-positive bacteria especially S.aureus, including MRSA, a leading cause of surgical site infections. The award of ILAP is vital for ensuring this treatment is available for patients' use as soon as possible."
Professor Mark Wilcox OBE, National Specialty Advisor Infection Prevention & Control and Antimicrobial Resistance at NHS England and Head of Microbiology Research & Development at Leeds Teaching Hospitals NHS Trust commented: "MHRA's backing of XF-73 for the innovative medicines pathway is a key step that should enhance the clinical development of this novel anti-staphylococcal agent. As resistance to currently available anti-staphylococcal antibiotics continues to evolve, speeding access for patients to a new, safe and effective alternative antimicrobial is welcome news."
The Company will now collaborate with ILAP to enable further development of its innovative clinical trial designs to ensure rapid patient access, through acceleration of time to market and early incorporation of key endpoints for reimbursement. XF-73 Nasal is a Phase 3 ready asset designed to prevent post-surgical infections occurring, including MRSA.
For further information, please contact:
Destiny Pharma plc
Chris Tovey, CEO
Shaun Claydon, CFO
+44 (0)1273 704 440
FTI Consulting
Ben Atwell / Simon Conway
+44 (0) 203 727 1000
destinypharma@fticonsulting.com
Shore Capital (Nominated Adviser and Broker)
Daniel Bush / James Thomas / Lucy Bowden
+44 (0) 207 408 4090
About ILAP
The
About XF-73 Nasal
XF-73 is the lead drug candidate from Destiny Pharma's XF platform, initially being developed for the prevention of post-surgical staphylococcal infections, such as methicillin-resistant Staphylococcus aureus (MRSA), which cause significant complications and increased healthcare costs in the hospital setting. XF‑73 has been awarded both Qualified Infectious Disease Product (QIDP) and Fast Track status by the US FDA.
About Destiny Pharma
Destiny Pharma is an innovative, clinical-stage biotechnology company focused on the development and commercialisation of novel medicines that can prevent life-threatening infections. The Company's drug development pipeline includes two late-stage assets XF-73 Nasal gel, a proprietary drug targeting the prevention of post-surgical staphylococcal hospital infections including MRSA and NTCD-M3, a microbiome-based biotherapeutic for the prevention of C. difficile infection (CDI) recurrence which is the leading cause of hospital acquired infection in the US.
For further information on the company, please visit www.destinypharma.com.
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