Brilacidin is Innovation'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 synthetic, non-peptidic 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.
Innovation 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. The study is fully enrolled with topline results anticipated in 4Q2017.
Innovation also is testing Brilacidin, administered with water in an enema, in patients with Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS) — a 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 support Brilacidin as a novel, non-corticosteriod, non-biologic IBD treatment, with a majority of patients treated achieving induction of clinical remission. Formulation development plans include foam and/or gel for the treatment of UP/UPS and oral tablets for the treatment of UC and Crohn's.
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 as an intravenously-administered medication in treating Acute Bacterial Skin and Skin Structure Infection (ABSSSI). Trial data showed 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.”
— 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. 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. Another patent for compounds for use in treatment of mucositis received formal notice of Intent to Grant from the U.S. Patent & Trademark Office in March 2017.