Cellceutix’s Phase 2 Drug Candidate Brilacidin Emerging as a Potential Novel Non-Biologic Therapy in Treating Inflammatory Bowel Disease
BEVERLY, Mass., March 16, 2017 (GLOBE NEWSWIRE) -- Cellceutix Corporation, (CTIX) (“the Company”), a clinical stage biopharmaceutical company developing innovative therapies with dermatology, oncology, anti-inflammatory, and antibiotic applications, is pleased to inform shareholders that, next week, the Company will be providing additional detailed data from its ongoing Phase 2a Proof-of-Concept (PoC) study of Brilacidin for the treatment of Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS), two types of Inflammatory Bowel Disease (IBD).
While advances in IBD treatment—specifically, the approval of Tumor Necrosis Factor (TNF) inhibitors—now offer patients more effective therapeutic options, biologics have major drawbacks. In addition to their high costs and the risk of serious side-effects is the potential loss of therapeutic response. One-third of patients on biologics lose response over time, often needing to be switched to another TNF inhibitor, and another one-third of patients fail to respond to TNF inhibitors at all. Moreover, management of IBD is moving from alleviation of symptoms toward long-term control of Gastrointestinal (GI) inflammation (preventing disease progression and recurrence). Avoiding initial treatment failure, which can cost an average of $11,500 per patient, and achieving sustained clinical remission, increasingly is a realistic goal for managing patients with IBD.
In short, there exists a large unmet need in treating IBD patients with newer, non-biologic therapies, which we believe Brilacidin, with its unique mechanism of action, is showing the potential of becoming.
Following the information released on March 8, 2017, disclosing preliminary efficacy and safety data as part of interim analysis from the first two cohorts (12 patients) in the UP/UPS trial, Cellceutix has received numerous requests from various interested parties to provide added context on Brilacidin and its potential in IBD. In the upcoming data release, we plan to provide further scope and breakdown of study results across the first two cohorts, along with other insights based on results observed to date. This summer, Cellceutix plans to present both topline findings from the complete Brilacidin-UP/UPS trial as well as interim data from its ongoing Phase 2 trial of Brilacidin for Oral Mucositis at Drug Discovery and Therapy World Congress 2017 to be held July 10 – 13, 2017 in Boston. More details to come.
“We have received excellent results, to date, in our Brilacidin IBD trial, both regarding objective scores and subjective assessments. The systemic absorption of Brilacidin has been minimal while still yielding compelling patient responses,” said Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Cellceutix. “We’re getting exactly what we need from a proof-of-concept study—clear and strong signals both as to the safety and the efficacy of Brilacidin in treating IBD. These results will help guide the continued development of Brilacidin, including planned foam and oral formulations, for hard-to-treat chronic conditions like Ulcerative Colitis and Crohn’s Disease.”
