Company and Yale University Hospital seeking participants with GA for Phase 1 trials of medicine FDA-approved for other ailments
TWi Biotechnology (TWiB), a clinical stage biopharmaceutical company specializing in development of repositioned drugs for unmet medical needs, is currently seeking participants for a Phase 1 clinical trial of a topical gel called tofacitinib for the treatment of granuloma annulare (GA). The TWiB team and collaborating physicians invite eligible individuals to participate in this groundbreaking study at Yale University Hospital.
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.
For further information, please contact:
Nicole Olszewski
Study Coordinator
+1-203-785-5505
nicole.olszewski@yale.edu
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 type of medicine called a JAK inhibitor, shows promise for GA — treatment with tofacitinib both improved skin disease and reduced circulating inflammatory biomarkers in all GA patients.
The current trial, using a topical treatment already approved for oral use to treat other, more common ailments, represents a significant step towards addressing this unmet medical need.
Repurposing an FDA-approved medicine
The oral formulation of tofacitinib has already been FDA approved to treat such ailments as 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 topically to the skin and tends to have lower systemic exposure compared to the oral route.
Addressing gaps in treatment
Channeling science and integrity to alleviate the suffering of patients, TWi Biotechnology specializes in rare diseases and dermatological diseases associated with inflammation or inflammatory conditions — typically helping patients that have been left behind by the larger pharmaceutical industry. 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.
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