Taipei, Taiwan, 1st November, 2022 / BRIM Biotechnology, Inc. (“BRIM,” TPEx 6885) is pleased to announce that it has received agreement from the US Food and Drug Administration (FDA) on the Phase 3 clinical trial design for its lead candidate for Dry Eye Disease (DED), BRM421, at the End of Phase 2 Meeting. BRIM will submit the Phase 3 study protocol to the FDA in Q4 2022.
Dr. Haishan Jang, Chair and CEO of BRIM, commented: “The End of Phase 2 feedback we have received is a crucial milestone in BRIM’s drug development program. We are delighted that the FDA has recognized our Phase 2 study results and agreed on our Phase 3 trial design. We have received essential feedback on future NDA requirements, and we are committed to following the FDA’s recommendations as we move forward with our Phase 3 preparations. This development will help us to speed up the path to market approval of BRM421 as a first-line treatment for DED, bringing us one step closer to providing a new therapeutic choice for DED patients with unmet medical needs.”
BRM421 is a novel, first-in-class regenerative peptide therapy which, if successful, could offer patients full relief of symptoms plus repair the damage to the cornea. BRM421 is derived from BRIM’s proprietary, stem cell regenerative PEDF-derived Short Peptides (PDSPs), which can also be applied across multiple therapy areas and indications. In the treatment of DED, PDSPs are known to activate the proliferation and differentiation of limbal stem cells which leads to rapid repair of the cornea. They also have anti-inflammatory effects and can maintain the function of goblet cells and meibomian glands to improve tear quality in the long term.
BRM421’s DED Phase 2 trial data showed that BRM421 repaired the cornea within two weeks and relieved patients’ symptoms within 8 days. The data showed that BRM421 has clinically meaningful benefits and is well tolerated.
There is currently no cure for DED, and there is a lack of treatment options available to patients. Currently, more than half of prescription drugs are anti-inflammatory medicines, and the rest are artificial tears or lubricants. These types of treatments are often not enough to control discomfort for moderate to severe patients unless there is a way to further speed up the healing process. Due to its unique mechanism of action, BRM421 has the potential to become the first DED treatment to offer rapid and total relief.