Taipei, Taiwan, 18th April 2023, BRIM Biotechnology, Inc. (“BRIM”, TPEx 6885) announced that BRM421 for the treatment of dry eye disease, licensed out to Grand Pharmaceutical Group Limited (Grand Pharmaceutical) for the China region, has been approved by the China National Medical Products Administration (NMPA) to conduct Phase 2 clinical trials. The trial is a single-arm, open-label clinical study that aims to recruit no more than 40 patients with moderate to severe dry eye disease and to evaluate the efficacy and safety of BRM421 in treating these patients.
The ophthalmology market in China is expanding, with a compound annual growth rate (CAGR) of 9.3% from USD 1.8 billion in 2015 to USD 2.6 billion in 2019. It is estimated to accelerate at a CAGR of 18.6% from 2019 to 2025 and reach a market size of USD 7.2 billion by 2025. The market size of dry eye disease in China has grown from USD 272 million in 2015 to USD 430 million in 2019, with a CAGR of 12.2%. It is estimated to grow at a CAGR of 28.4% from 2019 to 2030 and potentially reach USD 6.7 billion by 2030 [1].
BRM421 is a new peptide drug for treating dry eye disease developed from BRIM’s pigment epithelial-derived factor (PEDF) peptide platform (PDSP). It has a novel mechanism of action that can promote the proliferation of limbal stem cells and achieve corneal regeneration and repair. Data from completed Phase 2 clinical trials showed that BRM421 has a significant effect on symptoms after one week of treatment and is well tolerated with a good safety profile, giving it a significant advantage in the market competition. BRIM hopes to launch the drug in China as soon as possible through its collaboration with Grand Pharmaceutical and provide an affordable and effective treatment option for dry eye disease patients.
After licensing the commercial development rights in China, Hong Kong, and Macau to Grand Pharmaceutical in 2019, BRIM has been continuously developing BRM421. A multicenter, double-blind, randomized, vehicle-controlled Phase 3 clinical trial is ongoing in the United States. The US trial aims to recruit over 700 patients with moderate to severe dry eye disease, with topline results expected in Q4 2023, subject to enrollment status.
For more information, please contact:
BRIM Biotechnology, Inc.
Mei-hui Kuo / Henry Hsu
[t] 886 2 2659 8586 #109
[e] Henry.Hsu@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 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 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 this year. For more information, please visit the company’s website: http://brim.kehch.com/.
Disclaimer:
This press release and related information contain predictive statements, which are judgments and predictions based on existing risks and possible uncertainties, including market factors and other reasons beyond Brim Biotech’s control. These predictive statements are based on current predictions and evaluations and the company is not obligated to update them unless required by law.
References:
[1] http://pdf.dfcfw.com/pdf/H2_AN202104061481625025_15.pdf