It is being investigated as a new product for the prevention of the incidence of post-surgical infections such as methicillin-resistant Staphylococcus aureus (MRSA), associated with open wounds and broken skin.
READ: Destiny Pharma receives support from US government to develop ground-breaking wound infection treatment
The biotech firm said the primary efficacy endpoint was met with an “exceptionally high” statistical significance and there were no treatment-related safety events.
The gel achieved a 99.5% reduction in S. aureus bacterial nasal carriage, which the company said is a very effective reduction by accepted clinical measures.
It also showed more than a 99% reduction compared to the placebo in the same patient population. The effect was maintained during surgery, considered the period when the risk for infections is the highest.
Full results will be published in due course in a peer reviewed journal.
Destiny said there is a global need for better treatments such as XF-73 which has been awarded Qualifying Infectious Disease Product (QIDP) and Fast Track status by the US Food and Drugs Administration.
Destiny Pharma now plans to discuss possible Phase 3 clinical study designs with regulatory bodies including the US FDA.
The company believes that there is a significant commercial opportunity for XF-73 in the hospital setting which could generate peak annual product sales of up to US$1bn in the US alone.
"The completion of the Phase 2b clinical trial with XF-73 nasal gel is an important milestone in the fight against Staphylococcus aureus infections that occur in surgical patients,” said Richard Proctor, Professor Emeritus at the University of Wisconsin and member of the company's Scientific Advisory Board, in a release.
“These infections can be reduced by decreasing the numbers of S. aureus in the nose prior to surgery. XF-73 nasal gel was very well tolerated and highly effective in clearing these organisms,” he added,
“This antibacterial drug has a new mechanism of action which appears to address bacterial resistance enabling widespread use, unlike antibiotics. This trial is an important step in the fight against this worldwide epidemic of antibiotic-resistant S. aureus (including MRSA) as all attempts to date to develop an S. aureus vaccine have failed."
Analysts at house broker finnCap said this is a significant milestone for the company and a major valuation inflexion point, enabling Destiny Pharma to progress this asset towards Phase 3 development.
The broker increased the target price to 370p from 300p after increasing the probability of XF-73 being commercialised from 2025 from 53% to 67%.
"Whilst the shares have more than doubled year-to-date, we see further substantial upside," analysts commented.
"Destiny Pharma is an increasingly attractive investment opportunity focused on serious microbial disease prevention, which should have two Phase 3-ready assets (XF-73 having been awarded both QIDP and Fast Track status by the FDA) for development, licensing and/or co-development by the end of 2021."
Shares surged 32% to 210p on Monday morning.
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