Bausch Health Co. Inc. (BHC) Dermatology Unit, Ortho Dermatologics, Reports Statistically Significant Topline Results From 2nd Pivotal Ph. 3 Clinical Trial Evaluating IDP-126 Gel In Acne Vulgaris

April 22, 2021 7:09 AM EDT

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Bausch Health Companies Inc. (NYSE: 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.

Summary of Second Phase 3 Study Results The multicenter, randomized, double-blind, vehicle-controlled, 12-week study was designed to assess the safety, tolerability and efficacy of IDP-126 Gel in comparison to IDP-126 vehicle gel. The data was based on results from 193 participants nine years of age and older who were randomized to either receive treatment with IDP-126 gel applied topically to the face once daily for 12 weeks or administration of placebo (IDP-126 vehicle gel) applied topically to the face once daily for 12 weeks. The study was conducted at 13 locations in the United States. Treatment emergent adverse events (TEAE) reported in >2% of patients included application site pain, dryness, irritation, erythema, exfoliation and xerosis.

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