On February 8, 2016 Biota Pharmaceuticals, Inc. (NASDAQ:BOTA), a biopharmaceutical company focused on the discovery and development of direct-acting antivirals that address infections that have limited therapeutic options, reported that the first patient has been dosed in a Phase 2 double-blind, randomized, placebo-controlled trial to evaluate the safety, tolerability and efficacy of BTA074 5% gel in male and female patients with condyloma, or anogenital warts, caused by human papillomavirus (HPV) types 6 & 11 (Press release, Nabi Biopharmaceuticals, FEB 8, 2016, View Source [SID:1234508993]).

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"We are excited to progress BTA074 into a well-powered proof-of-concept study. The currently approved topical treatments for condyloma lack consistent efficacy and cause a considerable amount of undesirable local skin reactions, such as erosions and edema, often leading to the need to stop treatment. With this larger Phase 2 study, we hope to further validate the clinical activity of BTA074 seen in its earlier Phase 2 trial, which showed evidence of overall clearance and a benign side effect profile," remarked Joseph M. Patti, PhD, president and chief executive officer at Biota. "We now have three direct-acting antiviral programs in the clinic, each of which has the potential to help patients by attacking the root cause of their viral infections."

BTA074 is a potent and selective inhibitor of the interaction between two viral proteins from HPV6 and HPV11, and is designed to prevent HPV DNA replication. The Phase 2 trial is expected to enroll approximately 210 patients with anogenital warts and will have a 2-to-1 randomization of BTA074 5% gel to placebo gel. The patients will be dosed twice daily for up to 16 weeks. The primary efficacy objective is to determine the complete clearance rate for baseline anogenital warts from the commencement of therapy to the end of the treatment period. Secondary efficacy endpoints include various assessments of clearance and wart area reduction for both baseline warts and post-baseline emergent warts.