BRIM Biotechnology reported that development of its four ophthalmology programs is progressing on schedule. Among them, BRM424 for neurotrophic keratitis, which has shown encouraging preliminary Phase II data, is expected to complete patient enrollment by the end of the year. The most advanced program, BRM421 for dry eye disease, is preparing to initiate a Phase III clinical trial in the U.S. in the fourth quarter, while a Phase II dose-ranging study in Taiwan is scheduled to begin in September. For glaucoma, the BRM411 Phase I/IIb trial has already begun in Taiwan, with the Phase IIb portion expected to launch in October. Meanwhile, BRM412 is being developed for corneal neovascularization and is projected to begin Phase II enrollment in the first quarter of next year, following consultation with the U.S. FDA.
Chairman Andrew Lin noted that several regional pharmaceutical companies have entered due diligence for potential licensing deals. While BRM421 is still awaiting Phase III clinical results, both BRM424 and BRM411, with their clear differentiation, have already attracted strong interest from partners in the U.S., Europe, Japan, and South Korea. Among them, BRM424 is expected to be the first to secure a licensing agreement.
To further expand its pipeline, BRIM is also pursuing strategic acquisitions and in-licensing opportunities. Lin explained that some earlier acquisition plans were disrupted by tariffs under former U.S. President Donald Trump, but progress has been made with new collaboration opportunities, which are expected to be finalized soon.
CEO Wen-Chyi Shyu said the BRM421 Phase III trial in the U.S. is slated to launch in Q4, alongside a 12-patient dose-ranging study in Taiwan, with enrollment starting between late September and early October. In addition, BRIM has carried out a compassionate-use case for a patient with severe limbal stem cell deficiency. After more than six months of BRM421 treatment, both symptoms and quality of life improved significantly. The company now plans to expand compassionate-use enrollment for limbal stem cell deficiency in the U.S. to 5–10 patients, exploring new applications for BRM421.
Chief Technology Officer Lin, Cheng-Wen highlighted that BRM411 is a dual ROCK1/2 inhibitor that acts directly on the trabecular meshwork, improving nighttime intraocular pressure (IOP) control, which is particularly important for normal-tension glaucoma common in Asian patients. Phase I/IIa trials completed in Australia and Malaysia showed that BRM411 achieved IOP reduction comparable to marketed ROCK inhibitors but with a superior safety profile. The formulation has since been optimized, and manufacturing of the clinical drug product has been completed.
The Phase I/IIb trial to confirm BRM411’s efficacy has already been approved by Taiwan’s Ministry of Health and Welfare. Given the new formulation, a short Phase I study in Taiwan will be conducted first, enrolling six patients and completing within about a week, before rapidly moving into the Phase IIb portion. Enrollment for Phase IIb, targeting around 200 patients, is expected to begin in October.
For BRM412, BRIM has chosen to focus on corneal neovascularization by developing an anti-angiogenic eye drop. A meeting with the FDA is planned for early October to discuss indication and trial design. If successful, BRM412 will move directly into Phase II, with patient enrollment scheduled to start in the first quarter of next year. Based on discussions with ophthalmologists, the program has a clear positioning, significant market potential, and could extend to other ocular surface diseases associated with neovascularization.
Resource: 全福生技四項眼科新藥依計畫推進，新合作開發近期敲定
