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 (HNC) who have received chemoradiation. Topline study results indicate Brilacidin has a high potential for preventative treatment, as evidenced by a clear reduction of Severe OM (SOM) among patients on Brilacidin as compared to those on placebo. Additional secondary endpoint analysis, showing Brilacidin delayed the onset as well as reduced the duration of SOM, supports the drug candidate's therapeutic effect. The Company and the U.S. Food and Drug Administration (FDA) have completed an End-of-Phase 2 meeting. Both parties agreed to an acceptable Brilacidin Phase 3 development pathway. The total Brilacidin oral mucositis market opportunity in HNC annually in the U.S. and Europe is estimated to be approximately $600 million to $1.2 billion.
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. Of note, the academic literature suggests a defensin/mucin deficiency in IBD, impacting the mucosal immune system, indicating Brilacidin may have a compensatory effect in this regard.
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 a late-stage antibiotic drug candidate, 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.