Cellceutix Submits SPA Request for Brilacidin Phase 3 Trial

Cellceutix Corp. (OTCMKTS:CTIX) announced that it’s submitted a Special Protocol Assessment (SPA) request, along with a final protocol, to the US Food and Drug Administration. Both are regarding a Phase 3 clinical trial for the company’s single-dose antibiotic Brilacidin.
As quoted in the press release:

A SPA is a written agreement between the U.S. Food and Drug Administration (FDA) and a drug sponsor detailing the clinical trial design, endpoints and other clinical trial facets that can be used to support regulatory approval, thereby potentially reducing the risk of bringing a drug to market. The SPA submission is the next step in beginning a phase 3 program in ABSSSI after a successful End-of-Phase 2 Meeting with FDA last 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 and is uniquely qualified to treat Gram-positive pathogens, particularly MRSA, without adding to the burden of antimicrobial resistance.  Brilacidin offers several key advantages over recently approved ABSSSI antibiotics, which are newer members of existing antibiotic classes and, as such, are more prone to the development of cross-resistance among bacteria.   Like other single-dose ABSSSI regimens, Brilacidin maximizes adherence to the full treatment course, and therefore removes non-compliance as a driver of resistance. However, Brilacidin has the advantage of an intermediate half-life, while other single-dose ABSSSI regimens have very long half-lives, which means these drugs can remain in the body for weeks at low levels, which could further promote the development of resistance.  Moreover, Brilacidin has activity against stationary phase bacteria, which play a role in persistent infections and biofilm formation.  Finally, Brilacidin has anti-inflammatory properties that may accelerate and promote clinical healing. FDA designated Brilacidin as a Qualified Infectious Disease Product (QIDP) under the GAIN Act in November, 2014.

Click here to read the full Cellceutix Corp. (OTCMKTS:CTIX) press release.