BRIM Biotechnology, Inc. (“BRIM”) was founded in 2013 by a small group of entrepreneurial global pharma veterans who share the same vision, which is to create an innovative business model and integrate functional expertise in translational sciences to develop high quality, affordable new drugs for patients. Therefore, BRIM effectively controls costs and shortens the timeline for the development of pharmaceutical drug. Moreover, according to the experience results and the marketing intelligence, it is timely and decisive to decide whether to continue or abandon the research and development project. With limited funds and flexible business strategies, BRIM can create maximum benefits for patients, employees and investors.
Since its establishment 7 years ago, BRIM has constantly sought new drug candidates from the academic and research centers. After a rigorous study of the project and drug development process, the innovative PEDF-derived short peptide (PDSP) technology platform is one of the fastest growing in BRIM. This platform has a complete international patent layout and a unique mechanism of action that can be widely applied to multiple indications. Among them, the new mechanism for the treatment of dry eye BRM421 has: (1) facilitating corneal repair via promoting limbal stem cells (LSCs) proliferation, (2) improving tear quality via increasing the number of conjunctival goblet cells and restoring mucin production, and (3) preventing desiccating stress induced-cell damage via anti-inflammation and anti-oxidation. Within 18 months, BRIM completed all the pre-clinical studies and FDA IND submission of BRM421. Since no systemic exposure and toxicity were observed in animal pre-clinical study, the phase 1 study was waived and BRM421 entered the phase 2 first-in-human (FIH) clinical trial directly in 2017. In this randomized clinical trial, the data from 157 participants showed the excellent safety profile of BRM421 accompanied with the significant improvement of Tear Film Break-up Time (“TFBUT”), burning scores and visual function. In addition, BRM421 significantly improved numerous Dry Eye Syndrome (DES) signs (corneal staining) and symptoms (visual function and dryness) with early onset of action in moderate to severe DES patients. BRM421 is the first-in-class drug that promotes corneal repair directly and shows corneal re-epithelialization effect for DES treatment. The multiple unique mechanisms make BRM421 applicable to the treatment for DES with different causes.
BRM421, new drug for dry eye is currently undergoing trials in the United States for 200 patients (Clinical Phase II/III). BRIM has completed the future marketing authorization of BRM421 and has proceeded in parallel with the introduction of strategic investors in China, Hong Kong and Macau. The out-licensing deal upfront will be used to support the follow-up research of the drug development and enhance company value, so that the company could be expected to reach a new milestone. Moreover, BRIM is also actively training a research team and then has established a spin-off company "Ascendo Biotechnology, Inc." in 2019. Based on corporate social responsibility, BRIM cultivates the person who is practicing cross-field innovative drug development and organizes public seminars on translating new medical knowledge. Through this effort, BRIM recognizes the responsibility of establishing good public relations with researchers, medical staff and patients to enhance Taiwan's new drug development knowledge and to promote the upgrading of Taiwan's biotechnology industry.