Destiny Pharma's XF-73 Nasal Awarded MHRA ILAP

Destiny Pharma PLC

11 June 2024

 

Destiny Pharma plc

("Destiny Pharma" or "the Company")

Destiny Pharma Awarded Innovation Passport Designation by the UK MHRA for XF-73 Nasal for the Prevention of Post-Surgical Site Infections

·    Innovation Passport provides entry to the UK's Innovative Licensing and Access Pathway (ILAP), which aims to accelerate time to market and facilitate patient access to innovative medicines in the UK for life-threatening or seriously debilitating conditions, or conditions for which there is a significant patient or public health need.

·    XF-73 Nasal is an innovative medicine developed to prevent post-surgical infections and is potent against all MRSA strains.

Brighton, United Kingdom - 11 June 2024 - Destiny Pharma (AIM: DEST), a clinical stage biotechnology company focused on the development and commercialisation of novel medicines to prevent and cure life threatening infections, today 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.

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

[phone]

[e-mail]

FTI Consulting

Ben Atwell / Simon Conway

[phone]

[e-mail]

Shore Capital (Nominated Adviser and Broker)

Daniel Bush / James Thomas / Lucy Bowden

[phone]

About ILAP

The UK Medicines and Healthcare products Regulatory Agency (MHRA) launched ILAP at the start of 2021 in order to accelerate the development of, and access to, promising medicines. The pathway, part of the UK's plan to attract life sciences development in the post-Brexit era, 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. More information about ILAP can be found here.

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.

Forward looking statements

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