BRIM submits IND for BRIM424 phase 2 study treating neurotrophic keratitis

BRIM noted in the release it will take advantage of BRM424’s ODD status and enjoy the benefits of development cost reduction. (Image courtesy of Adobe Stock/Nejron)

BRIM Biotechnology Inc. submitted an 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.

According to a news release, 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.

Wen Chyi Shyu, PhD, CEO of BRI Biotechnology, pointed out that 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,” she said in the news release. “Therefore, it can rapidly repair the damaged cornea, and potentially be used to treat patients with severe corneal damage.”

Moreover, BRIM noted in the release it 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.