Certa Reports Positive Phase 2 Results in Scleroderma

Rare Daily Staff

Certa Therapeutics reported positive results from a phase 2 study of FT011, its experimental therapy for scleroderma, a potentially life-threatening autoimmune condition.

Scleroderma is characterized by inflammation and fibrosis of the skin and other organs, which often involves the lungs, kidneys, and heart. The condition has a substantial impact on quality of life, with patients commonly experiencing loss of mobility and function, pain, fatigue, often accompanied with a significant impact to their mental health. Scleroderma has the highest mortality among rheumatic diseases.

The phase 2 study compared treatment with FT011 to placebo and found it led to significant improvements across multiple efficacy measures including; the American College of Rheumatology Combined Response Index in diffuse cutaneous Systemic Sclerosis (CRISS) score, skin thickness (defined by the modified Rodnan Skin Score, mRSS), lung function ( percent FVC), physician-reported assessment and quality of life evaluations. The ARC-CRISS results describe a composite measure of disease state and organ damage that predicts the probability of improvement from baseline in scleroderma patients as a range between 0.0 to 1.0, with a score of greater than 0.6 indicating a clinically meaningful improvement.

Certa’s phase 2 trial demonstrated that treatment with FT011 resulted in a clinically meaningful improvement in 60 percent of patients treated with FT011 400mg dose and 20 percent of patients in the FT011 200mg group. Three patients in the pooled FT011 group achieved a maximum CRISS score of 1.0, representing the greatest probability of clinical improvement.

An open label extension phase of the trial is ongoing where a sub-set of patients who completed the main study (up to week 12), have elected to remain on treatment (FT011 400 mg) for an additional nine months.

The study safety profile demonstrated that FT011 was safe and well tolerated, with no differences in adverse event rates between the treatment arms. There were no serious AEs reported in the study, nor any AEs resulting in study drug interruption, withdrawal, or discontinuation.

“The changes seen in CRISS score, lung function, and physician reported outcomes in addition to the patient reported outcomes within such a short treatment timeframe of 12 weeks, is unprecedented and paves the way for a confirmatory global phase 3 study,” said Certa Therapeutics CEO and Founder Darren Kelly.

Photo: Darren Kelly, CEO and founder of Certa Therapeutics