BRYN MAWR, PA — Opsidio, LLC, a biopharmaceutical company, has announced the first patient dosing in their Phase 2a clinical trial of OpSCF. This pioneering monoclonal antibody developed by Opsidio is designed to treat moderate to severe atopic dermatitis, a chronic skin condition characterized by inflammation and itching.
“We’re thrilled to announce the start of our Phase 2a study for atopic dermatitis,” said Dr. Martin Phillips, CEO of Opsidio. “This marks a significant milestone in our mission to improve the lives of patients with chronic inflammatory conditions.”
The trial, codenamed OpSCF-201, is a randomized, double-blind, placebo-controlled study assessing the efficacy and safety of OpSCF in adults with moderate to severe atopic dermatitis. The primary goal is to determine the percentage change in the Eczema Area and Severity Index (EASI) score from the baseline at week 16.
Secondary objectives include evaluating the safety and tolerability of OpSCF, as well as improvements in pruritus (itching), body surface area affected, and quality of life for patients. Notably, OpSCF-201 includes an open-label extension period of 40 weeks, ensuring all subjects have the opportunity to receive OpSCF while participating in the study.
OpSCF was previously evaluated in a phase 1a/b study involving 115 subjects and was found to be safe and well-tolerated following single or multiple ascending dose administration in healthy volunteers.
Opsidio is collaborating with AbbVie, a global, research-driven biopharmaceutical company, for the development of OpSCF. This partnership underscores the potential of OpSCF as a game-changing treatment for atopic dermatitis.
The commencement of Phase 2a clinical trials marks a significant step forward in Opsidio’s journey to bring innovative treatments to patients suffering from chronic inflammatory conditions. The study’s findings will be eagerly awaited by both the medical community and those affected by atopic dermatitis.
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