GCIDestiny Pharma shares jump on major endorsement of lead asset XF-73 Nasal by UK regulator
() , a clinical stage biotechnology company, 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 its XF-73 Nasal candidate for the prevention of post-surgical infections.
The announcement is significant as it represents a major endorsement by the MHRA of Destiny's lead asset XF-73 Nasal. The granted pathway ILAP 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.
MHRA launched ILAP in 2021 in order to accelerate development of promising medicines in the post-Brexit era. It is part of the UK's broader plan to attract life sciences development and features enhanced input and interactions with MHRA and other stakeholders.
Other benefits of ILAP include access to a range of development tools, such as the potential for a 150-day accelerated marketing authorisation application (MAA) assessment, rolling review, and a continuous benefit risk assessment.
ILAP 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 can facilitate clinical research activities and provide practical and regulatory support.
Destiny noted that the MHRA ILAP steering committee has acknowledged that XF-73 Nasal is already at a late stage of development with a well-developed target development profile, which can be rapidly advanced through the abovementioned benefits offered by the ILAP toolkit. These include recommendations from the patient engagement team, clinical trial application and guidance, and advice and conditional marketing authorisation.
View from Vox
Major news from Destiny Pharma as its lead asset XF-73 Nasal gains the backing of the MHRA for the key innovative medicines pathway. Effectively, this means the UK's drug regulatory agency has recognised the importance of XF-73 Nasal, its potential to address a significant unmet clinical need, and granted access to a wide range of tools to advance its development. The announcement elicited a strong reaction from markets, driving shares 18% higher in early trade.
The granting of the ILAP pathway should significantly speed up the time to market of 's novel anti-staphylococcal agent aimed at preventing post-surgical site infections. XF-73 Nasal can be particularly disruptive as a powerful alternative to antibiotics as antimicrobial resistance continues to evolve. Clinical data underpinning XF-73 has been excellent, including a stellar safety profile and efficacy against a wide range of bacteria, prompting MHRA's move.
The ILAP pathway incorporates patient engagement to help accelerate drug development, as well as input from NICE. The latter serves as basis for early discussions around market access, enabling pricing and reimbursement considerations to be factored in at an early stage. will now collaborate with ILAP to advance its clinical trial designs and incorporate key endpoints for reimbursement. XF-73 Nasal is already a Phase 3-ready asset, so investors should expect a quick time to market following today's announcement.
Surgical site infections are serious, potentially life-threatening complications, affecting large numbers of patients. They are a strain on healthcare systems, costing approx. US$10bn a year in the US alone. As such, there is significant unmet demand anticipated for XF-73 Nasal. Market analysis on the candidate has shown a potential worldwide market of US$2bn.
The endorsement by the MHRA builds on XF-73's existing US FDA Qualifying Infectious Disease Product status as the asset now has significant regulatory backing in its major markets. With a comfortable year-end cash balance of £6.4m, is funded through to Q1 2025, allowing it to deliver on its current planned activities.
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