IDP-126 Meets Endpoints in Second Phase 3 Study

Ortho Dermatologics, a Bausch Health Company, announced results from its second phase 3 trial (NCT04214652) investigating the safety and efficacy of IDP-126 (Ortho Dermatologics)) for the treatment of acne vulgaris in patients 9 years and older.¹

This study, a phase 3, multicenter, randomized, double-blind, vehicle-controlled trial, met all coprimary endpoints by week 12.

The endpoints were the absolute change from baseline in inflammatory lesion count and noninflammatory lesion count, and percentage of patients who achieved treatment success. The treatment success was defined as clear or almost clear skin in the Evaluator’s Global Severity Score (EGSS). 

“Most acne patients are treated with a regimen that includes several different classes of medicine because of the complicated nature of the disease. This approach can be cumbersome for patients and exacerbate poor adherence rates, which are already low for acne patients when using simple regimens,” said Scott Hirsch, president of Ortho Dermatologics, and senior vice president and chief strategy officer of Bausch Health, Laval, Canada. “Dermatologists have been asking for a triple combination therapy to help them combat this issue for decades. Ortho Dermatologics has achieved a technological breakthrough with IDP-126 to deliver on this need, which, if approved, will provide the first and only triple combination treatment option to help patients struggling with acne.”

Results from the study were based on 193 patients, 9 years and older, that participated in the trial. The patients were randomized to receive IDP-126 gel or vehicle once daily for 12 weeks.

Out of the two treatment arms, 50.5% of the IDP-126 arm achieved EGSS clear or almost clear compared to 20.5% vehicle. Some patients achieved benefits from treatment as early of 2 weeks. 

The treatment emergent adverse events (TEAEs) that were reported in less than 2% of patients such as application site pain, dryness, irritation, erythema, exfoliation, and xerosis. 

“The impressive results of this second phase 3 study for IDP-126 are consistent with the results seen in the findings from the first Phase 3 study, particularly the strong efficacy results. I am encouraged that, if approved, IDP-126 will deliver a triple-combination therapy – three active ingredients in one product – which could simplify the treatment regimen and have a meaningful impact on my patients suffering from acne,” said Linda Stein Gold, MD, director, Dermatology Clinical Research, Henry Ford Health System, Detroit, Michigan.

If approved, IDP-126 would be the first treatment that is a combination retinoid, antibacterial and antibiotic topical. 

Reference:

1. Marks K. Ortho Dermatologics announces statistically significant topline results from second pivotal phase 3 clinical trial evaluating idp-126 gel in acne vulgaris. Published online April 27, 2021.