Cellceutix announced another important milestone in the development of Brilacidin™, the lead compound in a novel class of antibiotics known as defensin-mimetics. In the Company’s phase 2b study on patients with acute bacterial skin and skin structure infections (ABSSSI), an independent Data Safety Monitoring Board (DSMB) gave a positive review of interim safety data, collected after approximately 50% of the subjects were enrolled. The DSMB is composed of two cardiologists, one neurologist , and one statistician, and its mandate is to monitor and promote the safety of study participants.
The DSMB recommended that Cellceutix continue the trial as planned. That is the best possible outcome. Independent experts did not observe any concerning safety signals in the study. In addition, the Company reports there are no treatment-related Serious Adverse Events (SAEs), and none classified as cardiovascular or neurological, thus far in the study.
Previous brilacidin phase 1 and 2 studies have indicated the drug is safe and effective in the treatment of ABSSSI caused by Staph aureus, including methicillin-resistant Staph aureus (MRSA). Any treatment-related adverse events in past trials were more likely due to a higher total dose of study drug. However, in the current study, brilacidin is given as a single-dose regimen in two treatment arms (0.6 or 0.8 mg/kg) , and in the third arm, it is given as a 3-day regimen, which represents the highest amount a subject could receive (total 1.2 mg/kg). Of note, the highest amount is still lower than the lowest amount of brilacidin given in the previous phase 2 ABSSSI study, which concluded in 2012.
Mr. Ehrlich commented, “Well this news confirms our initial opinions on Brilacidin’s safety. Concerning Brilacidin’s efficacy, we know from the earlier phase 2a study the drug is amazingly effective and can stand up to any potential competitor. Add in the facts that we are seeking a one-time dose regimen and the belief that antibiotic resistance to Brilacidin is highly unlikely to develop, we are very optimistic we have a winner. Brilacidin breaches the bacteria’s cell wall. How do you build resistance to a bullet? Enrollment in the study is now approximately 80% complete. We look forward to the completion of the double-blind trial, which is anticipated in October, when we can then break the blind and see efficacy results as well as know if the existing drug safety profile continued throughout the remainder of enrollment. Add in the potential of Brilacidin for oral mucositis, diabetic foot ulcers, and eye and ear diseases, and you can understand what a game changer this drug alone brings to Cellceutix shareholders.”
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