Brim Biotechnology, Inc. has submitted an investigational new drug (IND) application to the FDA for BRM424, its novel regenerative peptide candidate for the treatment of neurotrophic keratitis (NK), to support the initiation of a phase 2 study.
Refresh me on Brim.
Based in Taipei, Taiwan, and established in 2013, BRIM Biotechnology operates a virtual business model in combination with its proprietary pigment epithelium-derived factor (PEDF)-derived short peptide (PDSP) technology platform that promotes the growth and expansion of limbal epithelial stem cells in severe ocular wounds.
In addition to BRM424, the company has two other ophthalmic pipeline products: BRM421 (for dry eye disease) and BRM423 (for corneal damage repair). The company has a third chemical entity under investigation for osteoarthritis (BRM521).
Talk about BRM424.
BRM424 is a first-in-class investigational drug that uses a synthetic peptide with an active pharmaceutical ingredient (API) composed of 29 amino acids derived from PEDF with neurotrophic and anti-inflammatory properties.
The peptide works by activating limbal stem cells to repair and regenerate the cornea using the same active pharmaceutical ingredients as BRM421, Brim’s DED candidate.
What has clinical data shown?
An NK rabbit model has found BRM424 to demonstrate preclinical efficacy and safety in compliance with regulatory requirements.
According to the company, studies have indicated that its dosing regimen could be significantly less frequent than current options, as well as a less costly treatment.
What else should I know?
BRM424 was previously granted orphan drug designation (ODD) by the FDA in December 2022. The intent, according to BRIM CEO Wen Chyi Shyu, PhD is to take advantage of the candidate’s ODD status and reap the benefits of development cost reduction.
So what’s next?
According to the company, if the FDA does not comment on the submission within 30 days, BRIM will initiate its phase 2 study on BRM424 within the first half of 2023.