BRIM submits US IND for BRIM424 phase 2 study treating neurotrophic keratitis

Taipei, Taiwan, 6th April 2023, BRIM Biotechnology, Inc. (“BRIM,” TPEx 6885), a clinical-stage biotechnology company advancing novel regenerative peptide therapies, submitted IND today for BRM424, which received ODD status from the FDA last November. If no comment from the FDA is received within 30 days, BRIM will initiate the BRM424 phase 2 study in the first half of 2023.

Neurotrophic keratitis (NK) is a rare degenerative disabling disease, caused primarily by damage to the trigeminal nerve, which leads to abnormal or loss of corneal sensation. With reduced corneal sensitivity, sufferers have insufficient tear production or blink frequency to respond effectively to outside stimulation or pressure. The cornea will experience persistent and repeated damage, leading to cornea thinning, melting, ulceration, and perforation. Infection is also common, and without treatment, the condition may lead to blindness.

Current treatment plans depend on the severity of the disease. After resolving any infection, artificial tears and/or anti-inflammation eye drops are commonly applied, whereas for more severe cases, an operation will be needed. While there is only one prescription drug approved for NK in the US and EU, Research and Markets report shows that the market size for the disease is USD 191 millions in 2022 and predicted to be around USD 439 million by 2027 with ~18.1% CAGR. ^[1]

BRIM’s CEO, Dr. Wen Chyi Shyu, explained: “BRM424 for NK and BRM421 for Dry Eye Disease share the same active pharmaceutical ingredient developed from BRIM’s PEDF-derived short peptide (PDSP) platform. This regenerative peptide has neurotrophic properties, and its mechanism of action is based on its ability to stimulate limbal stem cell regeneration. Therefore, it can rapidly repair the damaged cornea, and potentially be used to treat patients with severe corneal damage.” BRIM will take advantage of BRM424’s ODD status and enjoy the benefits of development cost reduction. For BRM424’s phase 2 trials, BRIM will open more clinical trial sites to speed up patient enrollment. The sooner the trial can be completed, the sooner NK patients may have an additional option for effective and affordable treatment.

ENDS

For more information, contact:

BRIM Biotechnology, Inc. 

Yi-Chun Maria Chen, PhD

T: 886 2 2659 8586 #110 

E: BD@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. 

References and further reading

1. https://www.researchandmarkets.com/reports/5650830/global-neurotrophic-keratitis-market-2022-2027
2. https://www.globaldata.com/store/report/dry-eye-syndrome-global-drug-forecast-and-market-analysis-to-2028/
3. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7841281/