The US Food and Drug Administration (FDA) has approved the Phase III clinical trial design for BRIM Biotechnology’s lead candidate for dry eye disease (DED), BRM421. BRIM will submit the Phase III study protocol to the FDA later this year.
BRM421 is a novel, first-in-class regenerative peptide therapy which, if successful, could offer patients full relief of symptoms plus repair the damage to the cornea.
It is derived from BRIM’s stem cell regenerative PEDF-derived Short Peptides (PDSPs), which can also be applied across multiple therapy areas and indications.
In the treatment of DED, PDSPs activate the proliferation and differentiation of limbal stem cells which leads to rapid repair of the cornea. They also have anti-inflammatory effects and can maintain the function of goblet cells and meibomian glands to improve tear quality in the long term.
BRM421’s DED Phase II trial data showed that BRM421 repaired the cornea within two weeks and relieved patients’ symptoms within eight days. BRM421 has the potential to become the first DED treatment to offer rapid and total relief.
Dr Haishan Jang, Chair and CEO of BRIM, commented: “We are delighted that the FDA has recognised our Phase II study results and agreed on our Phase III trial design. This development will help us to speed up the path to market approval of BRM421 as a first-line treatment for DED, bringing us one step closer to providing a new therapeutic choice for DED patients with unmet medical needs.”