April 07, 2023
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Brim submits investigational new drug application for neurotrophic keratitis treatment
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Key takeaways:
- Brim submitted an investigational new drug application for BRM424.
- BRM424 is a regenerative peptide that stimulates limbal stem cell regeneration to treat neurotrophic keratitis.
Brim Biotechnology submitted an investigational new drug application to the FDA for BRM424 for the treatment of neurotrophic keratitis, according to a press release.
If the FDA does not comment within 30 days, the company plans to initiate a phase 2 study to investigate BRM424 in the first half of the year.
Image: Adobe Stock.
“This regenerative peptide has neurotrophic properties, and its mechanism of action is based on its ability to stimulate limbal stem cell regeneration,” Wen Chyi Shyu, PhD, CEO of Brim, said in the release. “Therefore, it can rapidly repair the damaged cornea and potentially be used to treat patients with severe corneal damage.”
The FDA previously granted orphan drug designation to BRM424 in 2022.
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