Taipei, Taiwan, June 29th, 2021, BRIM Biotechnology, Inc. (“BRIM”) is pleased to advise that the Type C meeting with the US Food and Drug Administration (FDA) for the further development of lead candidate BRM421 for Dry Eye Disease (DED) has taken place, and preparation to initiate Phase III trials in 2022, is underway.
BRIM421 is a first-in-class peptide derived from BRIM’s proprietary, stem cell regenerative, Short Peptide (PDSP) technology platform, which can also be applied across multiple therapy areas and indications. Data demonstrate the drug has the potential to repair damage caused to the cornea as well as treat disease symptoms.
The Phase II/III trial was conducted in the U.S. in 2020, with over 200 patients. Data support an excellent safety profile, with no serious adverse events (SAEs) and successful completion by 100% of patients taking part in the trial. Importantly, results demonstrate significant improvements (p<0.05) in secondary outcome measures on Day 8: visual analogue scale (VAS) dryness, VAS burning/stinging and VAS photophobia, and most notably a strong trend of improvement in primary outcome corneal repair (p=0.1) at Day 15. The overall results show that BRM421 is safe and well-tolerated with a unique early onset of curative effect.
Dr. Haishan Jang, Chair and CEO of BRIM Biotechnology, commented: “Our two clinical trials have successfully demonstrated the strengths of our first-in-class lead asset BRM421, to treat and potentially cure dry eye syndrome. Millions of people world-wide are impacted by dry eye syndrome, with reported prevalence from 8% in the U.S. to rates higher than 30% in some regions of Taiwan and China. Currently, there is no permanent cure for dry eye syndrome, so we are particularly pleased with the results which confirm the disease-modifying effect of BRM421, and we are thrilled to be able to enter the next pivotal stage of clinical development.”
At the end of 2019, BRIM successfully licensed the commercial rights of BRM421 in China, to China Grand Pharma. Its Phase II clinical trial in China is expected to be initiated next year.
BRIM Biotechnology’s translational science expertise has enabled the rapid drug development and regulatory progression of BRM421. Within just 7 years, BRIM has completed pre-clinical studies, IND approval and two U.S. Phase II trials. The CMC development process will be completed to support the initiation of Phase III trials as early as in Q4 2022.
World Report on Vision. Geneva: World Health Organization; 2019. Licence: CC BY-NC-SA 3.0 IGO. Accessed June 2021 Available from: https://apps.who.int/iris/bitstream/handle/10665/328717/9789241516570-eng.pdf.
For more information, contact:
BRIM Biotechnology, Inc.
Yi-Chun Maria Chen
About BRIM Biotechnology, Inc.:
BRIM Biotechnology, Inc. was established in July 2013 to accelerate the drug development process from candidate selection through to late-stage clinical trials.
Based on our passion for going Beyond Research and Innovative Medicine, BRIM’s mission is to advance promising discoveries into disease-modifying treatments that transform patients’ lives.
The company’s virtual business model, combined with its unique PDSP technology platform, has proven to be effective in translating early stage research into clinical development.
BRIM has four lead products in the pipeline: BRM421, BRM423, 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.