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May 4, 2021

LoA Update: Ortho’s acne gel has approval likelihood clear by 12 points after positive, second Phase III trial

Ortho Dermatologics’ IDP-126 in moderate-to-severe acne vulgaris saw a 12-point upswing in its Likelihood of Approval (LoA) after positive topline results were reported from a second Phase III trial.

By Reynald Castañeda

Ortho Dermatologics’ IDP-126 in moderate-to-severe acne vulgaris saw a 12-point upswing in its Likelihood of Approval (LoA) after positive topline results were reported from a second Phase III trial. Topical gel IDP-126 previously had an LoA of 48%, rising to 60% as of 27 April, based on GlobalData’s analysis using a combination of machine learning and its proprietary algorithm.

In the second 180-patient Phase III trial, IDP-126 delivered statistically significant results in patients nine years old and above versus the vehicle arm, according to a 22 April media release by Bausch Health, Ortho’s parent company. The gel succeeded in the coprimary endpoints absolute change from baseline in inflammatory lesion counts (p<0.001), and noninflammatory lesion counts (p<0.001). It also succeeded in the coprimary endpoint percent of patients who achieved treatment success defined as “clear” or “almost clear” skin as per the Evaluator’s Global Severity Score (p=0.001).

Data from the second Phase III confirms the positive results from the first Phase III trial, according to the media release, but data from the first trial is yet to be detailed. IDP-126 is a combination of adapalene, benzoyl peroxide and clindamycin phosphate.

Reynald Castaneda is an Associate Editor for Clinical Trials Arena parent company GlobalData’s investigative journalism team. A version of this article originally appeared on the Insights module of GlobalData’s Pharmaceutical Intelligence Center. To access more articles like this, visit GlobalData.

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