Brim receives orphan drug designation for neurotrophic keratitis treatment
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The FDA granted orphan drug designation to BRM424 for the treatment of neurotrophic keratitis, according to a press release from Brim Biotechnology.
The drug uses a synthetic peptide made from 29 amino acids that activate limbal stem cells to regenerate and repair the cornea. The company is also developing a candidate for dry eye disease using the same active pharmaceutical ingredient, according to the release.
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Brim plans to apply for a phase 2 trial of BRM424 for neurotrophic keratitis in the United States.
“The novel regenerative effect of BRM424 could provide a new treatment option for patients that actively stimulates repair of corneal damage,” Haishan Jang, PhD, chairwoman and CEO of Brim, said in the release. “Our ongoing studies indicate that the dosing regimen will be significantly less frequent than current treatment options, and we estimate that the cost of treatment will be more affordable.”
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