BRIM Biotechnology Inc. announced that the first patient has been enrolled in its phase 3 clinical trial of BRM421 for the treatment of Dry Eye Disease (DED).
“DED affects millions of people worldwide, and there are insufficient treatment options to address the needs of people living with this disease. Due to its unique mechanism of action, BRM421 has the potential to become the first DED treatment to offer rapid and total relief,” said Dr. Wen Chyi Shyu, CEO of BRIM. “In just seven years, BRIM has licensed a technology platform from academia and through our translational science expertise, we have accelerated development to reach the first patient enrollment in our phase 3 study. Such rapid progress reflects the unique advantage of our PEDF-derived Short Peptide (PDSP) technology platform and validates our commitment to developing transformational treatments.”
The Phase 3, multicenter, double-blind, randomized, vehicle-controlled trial is being conducted in the US and plans to enroll more than 700 patients with moderate to severe DED. The topline results are expected to be revealed at the end of 2023.
With its unique mechanism of action, BRM421 phase 2 data demonstrates its potential to be a first-in-class regenerative peptide that repairs corneal damage and potentially relieves DED patients’ symptoms in just two weeks.
The phase 3 clinical trial will evaluate BRM421’s efficacy and safety for treating DED patients. Patients will be treated with BRM421 or vehicle control eye drops for two weeks, with evaluation on Day 8 and Day 15.
The co-primary endpoints for signs and symptoms are the total corneal fluorescein staining score on Day 15 and the visual analog score (VAS) of burning and stinging on Day 8.