On the back of the two positive Phase III trials, Ortho said it will submit a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) in the second half of 2022.
Bausch Health’s prescription dermatology subsidiary Ortho Dermatologics announced positive topline data from its second Phase III trial for IDP-126, a three-compound combination gel tested in 193 patients with acne vulgaris, showing reductions in both inflammatory and non-inflammatory lesions at week 12 in both trials. On the back of the two positive Phase III trials, Ortho said it will submit a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) in the second half of 2022.
IDP-126 is a combination of adapalene, a retinol, and anti-microbial benzoyl peroxide, both sold over-the-counter for acne, with clindamycin phosphate, a topical antibiotic that is often prescribed for acne. Physicians regularly prescribe combination therapies, and over a decade of clinical research in the field have explored retinol-antimicrobial combinations, including a Phase III trial of a clindamycin-tretinoin gel in combination with benzoyl peroxide wash by Stiefel, a GSK Company. Ortho is separately testing IDP-120 -- a combination of benzoyl peroxide and another retinol, tretinoin -- in a Phase III study for acne. And at least one other company, Vyne Therapeutics, is planning to launch two Phase III trials this year for FCD105, a topical combination of adapalene and antibiotic minocycline. But no company has an approved, single-agent therapy combining all three.
The multicenter, randomized, double-blind study assessed safety, tolerability, and efficacy of IDP-126, which met statistical significance for all three co-primary endpoints following daily topical application after 12 weeks. In addition to the reduction in both types of lesions from baseline, the therapy achieved “treatment success” -- a two-grade reduction in Evaluator’s Global Severity Score -- in 50.5% of patients, compared to 20.5% with vehicle. IDP-126 met all three endpoints in the first trial as well. More than 2% of patients experienced treatment emergent adverse events such as application site pain, dryness, or irritation.
Scott Hirsch, president of Ortho Dermatologics and SVP and chief strategy officer of Bausch Health, said the IDP-126 trial results “reinforce its potential as a first-in-class treatment option for millions of patients struggling with acne.”
Ortho also markets retinoids Aletrno (tretinoin) and Arazlo (tazarotene) to treat acne, as well as Bryhali (halobetasol propionate) and Duobrii (halobetasol propionate and tazarotene) for plaque psoriasis.
Several other therapeutic approaches are being explored in the clinic. Last week, Chinese small molecule company Kintor Pharmaceuticals announced it has begun dosing in a Phase I/II trial for pyrilutamide, a topical androgen receptor antagonist. And in March, phage therapy company BiomX began dosing patients in a Phase II study of BX001, a phage that targets Cutibacterium acnes bacteria linked to acne.
