Cellceutix, a clinical stage biopharma that develops novel therapies for oncology, dermatology, anti-inflammatory, and antibiotic applications, is announcing the institution of a “Database Soft Lock” as well as key additional updates to the company’s current development efforts.
Database Soft Lock
A Database Soft Lock or Database Freeze is a step in the regulatory process when all case information has been gathered and put into the database, with all known queries resolved. After this step, the Quality Assurance staff reviews all data points to ensure the statistics are accurate in the preparation of the dataset’s final analysis. The staff confirms that all data points, including pharmacokinetics (PK) data, are aligned with the Statistical Analysis Plan.
Phase 3 clinical trial of Brilacidin-ABSSSI Feedback
Cellceutix has also announced it has received U.S. FDA feedback on the company’s Special Protocol Assessment (SPA) for the Phase 3 trial of single-dose Brilacidin for the treatment of Acute Bacterial Skin and Skin Structure Infection (ABSSSI).
Getting SPA clearence is a significant step, as it reinforces the potential of advancing a promising drug into clinical development. The SPA agreement is grounded on key statistical and clinical endpoint requirements, moving the drug closer to FDA approval. As is customary, after revising a few changes required in the SPA feedback, Cellceutix will meet again with the FDA to discuss the proposed protocol toward establishing the final agreement.
Brilacidin is the first of a novel class of antibiotics, called defensing-mimetics. The antibiotic is modeled after the body’s own host-defense responses and has shown good results in killing bacteria, by penetrating bacterial cell wall membranes. Resistance to this type of antibiotic is much less likely to develop due to its specific mechanism of action. Brilacidin can also function in an immunomodulatory capacity, going beyond its antimicrobial properties, to lessen inflammation and promote healing.
“We are extremely proud of Brilacidin as it represents the first potential new class of antibiotics to treat serious skin infections in some 20-plus years and very much look forward to the start of the Phase 3 ABSSSI trial as soon as our SPA discussions with the FDA conclude,” said Cellceutix CEO Leo Ehrlich in a press release.
“There is a huge unmet medical need, worldwide, for newer and better antibiotics, with the market likely to gravitate toward single-dose drugs like Brilacidin. Commonly praised by clinicians once introduced to it, Brilacidin is positioned to help fill this void, and in the process, further unlock shareholder value. In addition, we see the ABSSSI clinical trials as a gateway for Brilacidin’s use in bacterial biofilm infections and its use in the treatment of diabetic foot infections,” he said.
Clinical Advisory Board Addition
Cellceutix announces the addition of Dr. Frances A. Farraye, M.D., MSc, to the company’s Clinical Advisory Board. Farraye is clinical director of gastroenterology at Boston Medical Center, and co-director of the Center for Digestive Disorders. He is a professor of medicine at the same institution. The New England CCFA named Farraye Humanitarian of the Year in 2003.
“We are thrilled to have Dr. Farraye formally join the Celleutix team. His expertise and leadership has been clearly demonstrated throughout his stellar career. Dr. Farraye’s experience and knowledge will help us explore Brilacidin’s potential in treating other gastroenterological conditions. Brilacidin continues to impress us as we explore its application in numerous clinical areas,” Ehrlich said.