TWi Biotechnology, Yale University Seek Participants With GA for Phase 1 trial of a Topical JAK Inhibitor

A small-scale study has already shown that oral tofacitinib improved skin disease and reduced circulating inflammatory biomarkers in all GA patients.

TWi Biotechnology (TWiB) is seeking participants for a Phase 1 clinical trial of a topical gel form of tofacitinib for the treatment of granuloma annulare (GA). 

Individuals with GA or friends and family members can find study information at: https://www.clinicaltrials.gov/ct2/show/NCT05580042?cond=Granuloma+Annulare&draw=2&rank=4.

GA is a rare skin condition affecting approximately 330,000 cases in the US, predominantly in women. It is characterized by raised bumps in a ring pattern, most commonly on the hands and feet, and while it is neither contagious nor causes pain, it can cause a high degree of self-consciousness. This can be particularly detrimental to patients with long-term cases or a highly visible rash, who can suffer from emotional distress.

The disease is poorly understood and has no effective treatment, Dr. William Damsky, MD, PhD of Yale School of Medicine — the clinical trial's principal investigator — has already conducted a small-scale study showing that oral tofacitinib, a JAK inhibitor, shows promise for GA.  Treatment with tofacitinib both improved skin disease and reduced circulating inflammatory biomarkers in all GA patients.

The oral formulation of tofacitinib has already been FDA approved to treat rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, polyarticular course juvenile idiopathic arthritis, and ankylosing spondylitis. The topical gel formulation of tofacitinib (AC-1101), which is being tested in this clinical trial, is applied to the skin and tends to have lower systemic exposure compared to the oral route.

TWi Biotechnology specializes in rare diseases and dermatological diseases associated with inflammation or inflammatory conditions . TWi Biotechnology's specialty of developing drugs for unmet medical needs focuses on drug repositioning — repurposing already-approved treatments for a different ailment. In particular, the company has demonstrated leadership in developing treatments for rare skin diseases, including epidermolysis bullosa simplex and GA.

For further information, please contact:

Nicole Olszewski
Study Coordinator
+1-203-785-5505
nicole.olszewski@yale.edu