LONDON (ShareCast) - (Sharecast News) - Clinical stage biotechnology company Destiny Pharma announced positive data and the non-irritant classification for its XF-73 nasal gel on Monday.
The AIM-traded firm said the data and classification were the result of its second Phase 1 safety clinical study, which examined its potential to cause irritation when administered topically.

It said the study, required under the Investigational New Drug (IND) application opened in February last year, achieved the primary objective of a low cumulative irritancy score for both concentrations - 0.05% w/w and 0.2% w/w - with "high statistical significance" when compared to a placebo of distilled water.

"We are very pleased with the positive outcome in this second Phase 1 study, which confirms the good safety profile of the XF-73 nasal gel formulation," said Destiny Pharma chief executive officer Neil Clark.

"We will now finalise plans for our key Phase 2b study testing XF-73 nasal gel as a novel therapy for the prevention of post-surgical staphylococcal infections, including MRSA.

"This is our lead indication targeting a billion-dollar US market and there is a clear medical need for a new drug that is safe, cost-effective and addresses the global medical concerns of antimicrobial resistance."

Clark said the positive results also supported the advancement of XF-73 in its Phase 1 dermal infection programme, and reinforced the target product profile of XF-73 for both indications.

XF-73 nasal gel was planned to move into Phase 2b clinical trials under the US Food and Drug Administration (FDA) Qualified Infectious Disease Product (QIDP) and Fast Track designation.

"This study will examine the nasal antibacterial activity and safety of the 0.2% w/w XF-73 nasal gel in over 150 patients at risk of post-surgical infections.

"The study design is under review at the FDA and it is planned to report data towards the end of 2019."

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