Beech Tree Labs Announces Positive Results for IND Phase 2 Oral Herpes Clinical Trials
Providence, RI, July 21, 2015 (GLOBE NEWSWIRE)—Beech Tree Labs, Inc. announced today that it has completed its second Phase 2 clinical trial in which its candidate product BTL-tml was evaluated for treating recurrent oral herpes infections. The primary endpoint of the randomized, placebo-controlled Phase 2b trial as well as the earlier Phase 2a trial was to prevent lesion formation. In contrast, other anti-herpes therapies focus on reducing the time it takes a lesion to heal as the chief measure of efficacy.
Participants in both trials were instructed to begin sublingual drop administration of BTL-tml upon first evidence of a herpes prodrome as characterized by tingling, itching, burning, or similar sensation. The goal was to abort later, more symptomatic lesion stages induced by either a dental procedure (Phase 2a) or exposure to ultra-violet light acting as a surrogate for excessive sun exposure (Phase 2b).
Combining relevant data from the Phase 2b and Phase 2a studies showed that more than 50 percent of all subjects experiencing a prodrome were able to avoid lesion development by timely administration of BTL-tml, resulting in clinical and statistically significant difference between BTL-tml treated patients and those receiving placebo. The adverse events profiles of the two groups were similar.
Beech Tree’s founder and CEO, Dr. John McMichael says, “The results of our Phase 2 evaluations of BTL-tml for the treatment of recurrent oral herpes infections are encouraging and provide the impetus to identify a partner to move forward with pivotal Phase 3 trials and initiate further controlled trials to test BTL-tml’s efficacy for treating additional members of the herpes family.”
About Beech Tree Labs, Inc.
Beech Tree is a leader in molecular signaling technology with an extensive patent portfolio that includes other therapeutics targeting a broad spectrum of chronic disorders.
The Company is privately held and specializes in discovery and early-stage development through Phase 2 clinical trials before licensing to larger pharmaceutical and biotech companies for continued evaluation and marketing.