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news.Cellceutix has submitted a special protocol assessment (SPA) request, along with a final protocol, to the US Food and Drug Administration (FDA), for a phase 3 clinical trial of its Brilacidin to treat acute bacterial skin and skin structure infection (ABSSSI).
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The novel single-dose antibiotic Brilacidin is indicated to treat ABSSSI caused by Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus.
A SPA is a written agreement between the FDA and a drug sponsor detailing the clinical trial design, endpoints and other clinical trial facets that can be used to support regulatory approval. The move lowers the risk of bringing a drug to market.
The SPA submission is the next step in starting a phase 3 program in ABSSSI after a end-of-phase 2 meeting with FDA in July 2015.
Brilacidin is the lead compound in a new class of antibiotics, the HDP mimics. It is the first completely novel antibiotic to enter a Phase 3 trial in ABSSSI in more than two decades.
It maximizes adherence to the full treatment course, and eliminates non-compliance as a driver of resistance.
Cellceutix said Brilacidin has the advantage of an intermediate half-life, while other single-dose ABSSSI regimens have very long half-lives, indicatingthat these drugs can remain in the body for weeks at low levels, which could further promote the development of resistance.
It has activity against stationary phase bacteria, which play a role in persistent infections and biofilm formation.
Brilacidin has anti-inflammatory properties that may speed up and promote clinical healing.