Certa Therapeutics (Certa), a biotechnology company specializing in precision therapies for inflammatory and fibrotic diseases, has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for its investigational therapy FT011, aimed at treating systemic sclerosis (scleroderma). This designation follows the prior Orphan Drug Designation granted to the therapy.

The Fast Track Designation comes after encouraging results from a Phase 2 study, showing significant improvements in scleroderma patients treated with FT011 over 12 weeks. Specifically, 60% of patients receiving FT011 at 400mg and 20% of those on the 200mg dose showed meaningful clinical improvement, compared to only 10% in the placebo group.

The FDA's Fast Track program expedites the development and review of new drugs for serious or life-threatening conditions, particularly those addressing unmet medical needs.

FT011 is a novel oral therapy targeting chronic fibrosis in multiple organs. It focuses on the previously untargeted membrane GPCR receptor, GPCR68, with robust data demonstrating efficacy in various fibrotic disease models. Transcriptomic research has further validated its mechanism of action, showcasing a reversal in the activation of genetic markers associated with fibrosis, presenting potential as a precision therapy.

Certa Therapeutics, expressed enthusiasm for the Fast Track Designation, emphasizing its role in accelerating the clinical development program for FT011. He highlighted the therapy's potential as the first anti-fibrotic and disease-modifying treatment for scleroderma patients, distinct from existing symptomatic relief-focused treatments.

Acknowledging the debilitating nature of scleroderma, which affects multiple organs and significantly impairs patients' quality of life, Certa is preparing for a pivotal clinical trial of FT011 as a scleroderma treatment. Discussions with the FDA regarding trial design and development plans are scheduled for early 2024, with additional scientific advice sought from the EMA later in the year, aiming to commence the pivotal study by late 2024.

Systemic Sclerosis, commonly known as Scleroderma, is an autoimmune condition characterized by inflammation and fibrosis of the skin and various organs, including the lungs, kidneys, and heart. Its impact on patients' mobility, function, and mental health underscores the urgent need for effective treatments, as it carries one of the highest mortality rates among rheumatic diseases.

 

Source: globenewswire.com

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