BRIM Biotechnology, Inc, in partnership with Ora, Inc, announced that it has initiated its phase 3 trial of BRM421 for the treatment of dry eye syndrome (DES) with the enrollment of the first patient.
Give me some background on the company.
Based in Tapei, Taiwan, and established in 2013, BRIM Biotechnology focuses on accelerating the development and transformation of early research technology platforms to clinical drug candidates, targeting diseases with unmet medical needs.
The company 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.
It currently has three lead ophthalmic pipeline products: BRM421 (for DES), BRM424 (for neurotrophic keratitis), and BRM423 (for corneal damage repair). Of note, the FDA granted Orphan Drug designation (ODD) for BRM424 in December 2022.
Now talk about BRM421.
BRIM’s first-in-class, lead investigational drug for DES is based on a neurotrophic stem cell regenerative peptide (PDSP) and is thought to work by stimulating limbal stem cell differentiation and proliferation resulting in an acceleration of corneal repair and reducing ocular surface inflammation.
Further, this compound could promote differentiation and proliferation of goblet cells which might enhance tear film quality.
How did it perform in previous trials?
Clinical results from a phase 2 trial found that BRM421 significantly improved symptoms of DES (p<0.05)—dryness, photophobia, burning/stinging—within 1 week of treatment.
Additional data found that it showed efficacy in the primary outcome of corneal repair (p=0.1) within 15 days. No serious adverse events were reported.
So what will this phase 3 trial include?
The multicenter, double-blind, randomized, vehicle-controlled trial will enroll 700+ patients diagnosed with moderate-to-severe dry eye across the United States. Investigators will be assessing BRM421’s efficacy and safety, with patients to receive either BRM421 or vehicle control eye drops for 2 weeks.
Anything else to know?
Evaluations will be conducted on Days 8 and 15; co-primary endpoints include the visual analog score (VAS) of burning and stinging (Day 8) and the total corneal fluorescein staining score (Day 15).
Significance?
Small molecule peptide chemistry has seen a rapid ascent in interest as a therapeutic target among several companies investigating the potential to develop them as a treatment for dry eye.
What’s next?
According to the company, topline results are expected by the end of 2023.