Benzinga | Apr 22, 2021 07:05AM EDT

Bausch Health Companies' Ortho Dermatologics Announces Statistically Significant Topline Results From Second Pivotal Phase 3 Clinical Trial Evaluating IDP-126 Gel In Acne Vulgaris

Bausch Health Companies Inc. (TSX:BHC) ("Bausch Health") and its dermatology business, Ortho Dermatologics, one of the largest prescription dermatology health care businesses, today announced statistically significant topline results from a second pivotal Phase 3 clinical trial evaluating its investigational medicine IDP-126, a combination retinoid, anti-bacterial and antibiotic topical, to treat acne vulgaris in patients nine years of age and older. If approved, IDP-126 would be the first-in-class with this triple combination.

Acne is the most common skin problem in the United States, affecting up to 50 million Americans.1,2

The second Phase 3 study confirmed the findings of the first Phase 3 study, which met all of its co-primary endpoints. This second Phase 3 study achieved all three co-primary endpoints at week 12 with statistical significance, including:

* Absolute change from baseline in inflammatory lesion count [p-value<0.001]

* Absolute change from baseline in non-inflammatory lesion count [p-value<0.001]

* Percentage of patients who achieved treatment success (defined as a two-grade reduction from baseline and 'clear' or 'almost clear' skin in Evaluator's Global Severity Score (EGSS)) (p=0.001)

Treatment success was 50.5% and 20.5% for IDP-126 and its vehicle, respectively. The data also demonstrated a benefit for patients as early as two weeks.

"The results from this pivotal Phase 3 trial indicate a strong safety, tolerability and efficacy profile for IDP-126 and reinforce its potential as a first-in-class treatment option for millions of patients struggling with acne," said Scott Hirsch, president, Ortho Dermatologics, and senior vice president and chief strategy officer, Bausch Health. "Following the results of a comparative bridging study, we hope to submit a New Drug Application for IDP-126 to the U.S. Food and Drug Administration in the second half of 2022."

"The positive results of this second Phase 3 study for IDP-126 are consistent with the strong, conclusive results seen in the findings from the first Phase 3 study. If approved, IDP-126 will deliver a triple-combination retinoid therapy -- three active ingredients into one product -- which could have a meaningful impact for my patients suffering from acne," said Linda Stein Gold, M.D., director, Dermatology Clinical Research, Henry Ford Health System.