BRIM Biotech submits US Phase 3 clinical trial protocol for BRM421 in the treatment of dry eye disease to the FDA

Taipei, Taiwan, Nov 16th, 2022, BRIM Biotechnology, Inc. (“BRIM,” TPEx 6885) announced today that it has officially submitted the Phase 3 clinical trial protocol for BRM421 in the treatment of dry eye disease (DED) to the U.S. Food and Drug Administration (FDA). If the FDA has no further comments after the 30-day review period, BRIM will proceed to initiate the Phase 3 clinical trial in December.

Based on its Preliminary Comments , the FDA has accepted the proposed Phase 3 clinical trial design submitted by BRIM for the End-of-Phase 2 (EOP2) meeting. The Phase 3 clinical trial will be a multi-center, double-blind, randomized, placebo-controlled trial in the United States. BRIM plans to enroll more than 700 patients with moderate to severe DED. The clinical trial is expected to be completed in the fourth quarter of 2023, depending on the status of patient enrollment.

Due to the aging population, the increase in the widespread use of electronic screens (especially during the COVID-19 pandemic), the prolonged use 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. GlobalData predicts that the global dry eye drug market will reach approximately US$11 billion in 2028, with a compound annual growth rate of 10.6% from 2018 to 2028.

Currently, there is no cure for DED, and there are limited treatment options available to patients. In the US, there are a small number of prescription drugs approved for DED, including Restasis (Allergan), Xiidra (Novartis), Eysuvis (Kala), and Tyrvaya (Oyster Point). Restasis and Xiidra work by inhibiting the inflammatory response of DED and stimulating tear production, but these drugs are expensive and accompanied by some unwanted side effects, such as burning and dysgeusia. Eysuvis is a corticosteroid that is only approved by the US FDA for a short-term treatment (up to two weeks) due to side effects. Tyrvaya is a nasal spray that stimulates tear production. It contains the same active pharmaceutical ingredient (API) as the one used in Chantix, an oral drug for smoking cessation. In terms of market share, currently, more than half of DED treatments are anti-inflammatory medicines, and the rest are artificial tears and lubricants.

BRM421 is a first-in-class, innovative drug based on a neurotrophic stem cell regenerative peptide (PDSP). It stimulates stem cell differentiation, repairs the cornea, inhibits inflammation, and promotes recovery in DED. Phase 2 clinical trial results have shown that BRM421 not only significantly improved DED symptoms including dryness, burning/stinging, and photophobia within one week of treatment, but also showed efficacy in repairing the cornea in 15 days. The data showed that BRM421 has an early onset of action and is well tolerated. Due to its unique mechanism of action, BRM421 has the potential to revolutionize DED treatment.

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

About BRIM Biotechnology, Inc.

BRIM Biotechnology, Inc. was established in July 2013 to acceleratethe development and transformation of early research technology platforms to clinical drug candidates.

BRIM applies efficient translational scienceto develop new treatments that help combatand 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 3 clinical trials in 2022. For more information, please visit www.brimbiotech.com.

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