FDA grants XF-73 Dermal QIDP for burn wound infections

Destiny Pharma
(“Destiny Pharma” or “the Company”)

Destiny Pharma Announces Qualified Infectious Disease Product Designation Granted by US FDA for XF-73 Dermal Gel for Treatment of Burn Wound Infections

Brighton, United Kingdom – 28 August 2024 – Destiny Pharma, a clinical stage biotechnology company focused on the development and commercialisation of novel medicines to prevent and cure life threatening infections, is pleased to announce that the US Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) designation to its XF-73 Dermal Gel for the treatment or prevention of Staphylococcal (including MRSA) infections in burn wounds.

Globally, (Greenhalgh et al., 2019) it is estimated that there are approximately 9 million burn cases per year. Burn injuries contribute to over 250,000 fatalities (Moeini et al., 2020) with infections identified as the cause of 61% of post-burn deaths (Gomez et al., 2009). Recent reports show the incidence of sepsis in burn patients ranges from 8% to 42% with related mortality from 28-65% (Cabral et al., 2017). Staphylococcus aureus, (including MRSA), is a common cause of post-burn infection; Alebachew et al., 2012 reported that patients with burns had a prevalence of S. aureus of 57.8%.

Under the US GAIN (Generating Antibiotic Incentives Now) Act, QIDP status confers FDA priority review, eligibility for fast-track status, and an additional five-year extension of US patent exclusivity when approval is granted.

The FDA grants QIDP designations to drugs intended to treat serious or life-threatening infections, caused by “qualified pathogens”. These pathogens include the hospital superbug, MRSA, which can cause devastating infection in burn wounds, and can lead to life-threatening blood infection, (sepsis).

In the USA, XF-73 Dermal Gel development has been supported and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), with the recent successful completion of a large-scale preclinical safety study, https://destinypharma.com/2024/08/05/xf-73-prevents-bacterial-invasion-of-bloodstream/

The Company has previously been successful in gaining QIDP status for its XF-73 Nasal medicine for the prevention of post-surgical staphylococcal (including MRSA) infections.

Dr Bill Love, Chief Scientific Officer of Destiny Pharma, commented: “The QIDP designation further underlines that medicines based on our breakthrough antibiotic XF-73 are recognised as being urgently required to prevent and treat life-threatening infections caused by hospital superbugs. We believe this award will assist in earmarking XF-73 Dermal Gel as a potential breakthrough medicine in the area of burn wound treatment.”

Chris Tovey, Chief Executive Officer of Destiny Pharma, said: “XF‐73 Dermal’s successful US FDA Qualifying Infectious Disease Product application builds on the previously successful US FDA QIDP grant for XF-73 Nasal and further reinforces the significant regulatory endorsement and recognition of XF‐73 potential in addressing the challenges of antimicrobial resistance along with highlighting the significant commercial potential.”

The Company previously resolved to appoint Stephen Cork and Mark Smith of Cork Gully LLP as Joint Administrators with effect from 21 August. The Joint Administrators continue to work alongside the Board of Directors and staff to progress discussions with potential investors, partners and interested parties with a view to achieving an optimal outcome. Any additional parties who have not already been in contact with the administration team are encouraged to contact them via the contact details provided below.

For further information, please contact:

Cork Gully LLP
Stephen Cork, Joint Administrator
Mark Smith, Joint Administrator
+44 (0)20 7268 2150
destiny@corkgully.com

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, 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 destinypharma.com

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