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BRIM Biotechnology announces first patient enrollment in pivotal Phase 3 clinical trial of BRM421 for Dry Eye Disease
Taipei, Taiwan, 2nd March 2023 / Sciad Newswire / BRIM Biotechnology Inc. ("BRIM," TPEx 6885), a clinical-stage biotechnology company advancing novel regenerative therapies to help combat and cure ophthalmology and degenerative joint diseases, announced today 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.
ENDS
For more information, contact:
BRIM Biotechnology, Inc.
Yi-Chun Maria Chen, PhD
[t] 886 2 2659 8586 #110
[e] yichun.chen@brimbiotech.com
Sciad Communications
Maria Patey / Sophie Protheroe
[t] 020 3405 7892
[e] BrimBiotech@sciad.com
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 Disease initiated Phase 3 clinical trials in 2022 and is expected to produce topline results at the end of 2023. BRM424 for neurotrophic keratitis will also enter a Phase 2 trial in the US in 2023. For more information, please visit www.brimbiotech.com.
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% [1]. 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 [2].
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