BRIM Biotechnology has initiated the Phase 3 clinical trial of BRM421 for the treatment of Dry Eye Disease (DED) and enrolled the first patient in the trial. This multicenter, double-blind, randomized, vehicle-controlled trial will enroll over 700 patients with moderate to severe DED patients in the US. The topline results of the trial are anticipated to be disclosed by the end of 2023.
BRM421 Phase 2 data demonstrate the potential for the peptide to be a first-in-class regenerative solution that can repair corneal damage and potentially alleviate the symptoms of DED patients in just two weeks.
The Phase 3 clinical trial aims to assess the efficacy and safety of BRM421 for treating DED patients. During the trial, patients will be given either BRM421 or a vehicle control eye drops for two weeks, and evaluations will be conducted on Day 8 and Day 15. The co-primary endpoints for signs and symptoms will be the total corneal fluorescein staining score on Day 15 and the visual analog score (VAS) of burning and stinging on Day 8.
“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 CEO added.