Tern Therapeutics Receives US FDA Fast Track Designation for TTX-381 Gene Therapy for the Treatment of the Ocular Manifestations of CLN2 Disease
Designation to expedite development of lead program TTX-381.
First-in-human clinical trial to evaluate TTX-381 is active and recruiting patients
Tern Therapeutics, LLC (“Tern”), a biotechnology company developing transformative one-time gene therapies for rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to TTX-381. TTX-381 is a novel one-time gene therapy product being developed for the treatment of the ocular manifestations of CLN2 disease, a form of Batten disease.
“We are pleased the FDA has granted Fast Track designation to TTX-381, recognizing its potential to transform the lives of patients with CLN2 disease,” said Alex Bailey, Ph.D., Chief Executive Officer of Tern. “This marks an important milestone for Tern and reinforces the promise of TTX-381 to address the rapid, relentless loss of vision caused by CLN2 disease. With this designation, we look forward to working closely with the FDA to accelerate development and bring this much-needed therapy to patients as quickly as possible.”
The FDA’s Fast Track program is designed to help drugs reach patients sooner by expediting the development and regulatory review of therapies that address serious conditions with unmet medical needs. This designation facilitates increased interactions with the FDA during the clinical development process, as well as ensures eligibility for rolling review, priority review, and accelerated approval. TTX-381 previously received rare pediatric disease and orphan drug designations from the FDA.
