BRIM Biotechnology receives FDA agreement on Phase 3 clinical trial design for BRM421, BRIM’s lead candidate for Dry Eye Disease, at End of Phase 2 Meeting
Taipei, Taiwan, 1st November 2022 / Sciad Newswire / 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.
For more information, contact:
BRIM Biotechnology, Inc.
Yi-Chun Maria Chen, PhD
T: 886 2 2659 8586 #110
Maria Patey / Sophie Protheroe
T: 020 3405 7892
Notes to Editors
About BRIM Biotechnology, Inc.
BRIM Biotechnology, Inc. was established in July 2013 to accelerate the development and transformation of early research technology platforms to clinical drug candidates.
BRIM applies efficient translational science to develop new treatments that help combat and cure disease. The company’s virtual business model combined with its proprietary PDSP technology platform, bridges the gap between research and clinical development faster, de-risks the process, and accelerates the progression of early-stage candidates in indications with high unmet medical needs. BRIM has three lead products in the pipeline: BRM421, BRM424, and BRM521, all of which are developed from its PDSP technology platform. Lead asset BRM421 for Dry Eye Syndrome is expected to enter Phase III clinical trials in 2022. For more information, please visit www.brimbiotech.com. Follow BRIM on LinkedIn and Twitter.
Further information about Dry Eye Disease
DED is a complicated disease with multiple causes. According to Global Data, the global DED market was worth approximately USD 3.9 billion in 2018. This is predicted to reach over USD 11 billion in 2028 with a CAGR of 10.6% . Due to the widespread use of electronic screens, prolonged wearing of contact lenses, and the increasing frequency of myopia laser surgery, the global dry eye population has risen rapidly in recent years, especially amongst younger age groups. In addition, research suggests that COVID-19 patients have a higher risk of developing DED .
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