BRILACIDIN

Brilacidin is Cellceutix's lead drug candidate in its defensin-mimetic franchise.

Modeled after Host Defense Proteins (HDPs), the “front-line” of defense in the body's innate immune system, it is a non-peptidic, synthetic, small molecule that kills pathogens swiftly, significantly reducing the likelihood of drug resistance developing. Just as importantly, Brilacidin functions in a robust immunomodulatory capacity, lessening inflammation and promoting healing.

Cellceutix is evaluating Brilacidin, under Fast Track designation, in a Phase 2 clinical trial as an oral rinse to attenuate Oral Mucositis in patients with Head and Neck Cancer who have received chemoradiation. Preliminary Interim Analysis indicates Brilacidin has a high potential for preventative treatment, as evidenced by a markedly reduced rate of Severe OM among patients on Brilacidin as compared to those on placebo.

Cellceutix also is testing Brilacidin, administered with water in an enema, in patients with Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS)—a limited type of Ulcerative Colitis (UC), and, like Crohn's Disease, an Inflammatory Bowel Disease (IBD)—in a proof-of-concept Phase 2 clinical trial. Topline findings, through the first two cohorts of patients treated, support Brilacidin as a novel and promising anti-inflammatory drug candidate. Both foam and tablet formulations of Brilacidin for use in future gastroenterological studies is planned and would be expected to improve patient convenience and study results.

As a mimic of HDPs, which play a key regulatory role in the etiology of skin diseases, and due to its limited systemic absorption when topically applied (a favorable pharmacokinetic profile), Brilacidin may have other applications in treating dermatological disorders. Additional trials of Brilacidin are planned in Acne, Hidradenitis Suppurativa and Atopic Dermatitis (Eczema).

A key aspect of Brilacidin's mechanism of action, inhibiting Phosphodiesterase 4 (PDE4), may further support its use in treating Asthma, Psoriasis, Psoriatic Arthritis and Chronic Obstructive Pulmonary Disease (COPD), alongside other chronic autoimmune conditions.

As an antibiotic, representing the first in a new class of anti-infectives, Brilacidin is being advanced in the clinic under Qualified Infectious Disease Product (QIDP) designation—qualifying the drug candidate for Fast Track and Priority Review, as well as an extra 5 years of market exclusivity upon drug approval. A Phase 2b trial was completed evaluating Brilacidin in treating Acute Bacterial Skin and Skin Structure Infection (ABSSSI), with the data showing a single dose of Brilacidin to be comparable in safety and efficacy to a 7-day dosing regimen of FDA-approved Daptomycin.

“BRILACIDIN HAS A HIGH LIKELIHOOD OF REACHING COMMERCIALIZATION. ANTIMICROBIAL PEPTIDES APPEAR TO BE COMING OF AGE AS THERAPEUTICS.”

— Dr. Michael Zasloff

Pre-clinical work has been conducted, as well, on the gram-negative, anti-fungal, biofilm and material applications of HDP-mimetic compounds.

Brilacidin and related compounds are protected under various composition and use patents. Recently, a patent was filed and is pending for the use of HDP-mimetics in the prophylaxis and/or treatment of inflammatory diseases of the gastrointestinal tract.

Click on the links below for a more in-depth introduction to Brilacidin and its multiple therapeutic applications.