LAGUNA HILLS, Calif.--(BUSINESS WIRE)--Hallux Incorporated, an investigational-stage pharmaceutical company focused on developing a new dosage form and route of administration for treating onychomycosis, announced the completion of Series A financing of $7.1 million. Deerfield Management led the round.
The new capital will be deployed to advance Hallux's proprietary terbinafine micro-insert dosage form into phase 2A clinical trials, with the goal of demonstrating safety, efficacy, and tolerability in patients with distal lateral subungual onychomycosis.
"Onychomycosis remains a major market in the United States and abroad that is generally underserved by existing prescription treatment options," said Mark Taylor, Hallux Chief Executive Officer. "The oral therapies carry the risk of systemic side effects while the topical products are associated with underwhelming cure rates and yearlong dosing requirements. Our approach utilizes subungual drug administration that delivers high concentrations of terbinafine directly to the site of infection. In this way, we hope to improve efficacy and compliance with negligible systemic exposure." Taylor continued, "We are grateful to Deerfield for their confidence and support and look forward to working closely with their highly experienced healthcare investment and operating teams in bringing this exciting new product and therapy to market."
Hallux is developing an investigational micro-insert for subungual delivery and treatment of distal lateral subungual onychomycosis. The dosage form is biodegradable and delivers high concentrations of terbinafine hydrochloride directly and selectively to the site of infection over a period of time. Results from pilot studies are encouraging and suggest that the subungual treatment procedure is safe and well tolerated. Hallux is planning to further evaluate efficacy, safety, and tolerability in a series of single site clinical studies commencing in the first half of 2016.