Destiny Pharma plc announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted an Innovation Passport under the Innovative Licensing and Access Pathway (ILAP) to XF-73 Nasal for the prevention of post-surgical site infections. ILAP is unique as it aims to accelerate the time to market and facilitate patient access to medicines in the UK for life-threatening or seriously debilitating conditions, or conditions for which there is a significant patient or public health need. The pathway provides access to the MHRA and its partner agencies: the National Institute for Health and Care Excellence (NICE); NHS England; National Institute for Healthcare Research (NIHR); Health Research Authority (HRA); the Scottish Medicines Consortium (SMC); and the All Wales Therapeutic and Toxicology Centre (AWTTC); who facilitate clinical research activities and provide practical and regulatory support which fosters an innovative and unified relationship with regulatory authorities.

The pathway actively incorporates the patient voice to help guide and accelerate drug development; and input from NICE leads to early discussions around market access, enabling pricing and reimbursement considerations to be factored in at an earlier stage. 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. 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.