BRIM Biotechnology, Inc. ("BRIM"), a clinical-stage company developing novel regenerative therapies in ophthalmology, today announces it has entered into a new strategic partnership with Ora®, Inc. ("ORA"), the world's leading ophthalmic research organization, for the late-stage clinical development of lead drug candidate, BRM421, for dry eye syndrome (DES). BRIM intends to initiate Phase 3 clinical studies with Ora's support later this year.
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BRM421 is based on BRIM's proprietary stem cell regenerative Pigment Epithelium-Derived Factor (PEDF) derived Short Peptide (PDSP) technology platform, which underpins several products in its pipeline and has the potential to be effective in multiple therapy areas and indications. The functional domain of PEDF chosen to generate PDSPs can be used to treat DES by speeding up the cornea repair process through stimulation of corneal stem cell proliferation and differentiation, anti-inflammation, and meibomian gland recovery.
Dry Eye Syndrome is a chronic disease that affects the productivity and quality of life of 1.52 billion people worldwide1. The COVID-19 pandemic has further exacerbated the problem, as prolonged time in front of screens is a risk factor for the disease. Other risk factors include aging, eye surgeries, dry environments, the long-term wearing of contact lenses, and autoimmune diseases. Unlike current treatments, 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.
"Ora is passionate about addressing the challenges of DES and honoured to be working with the BRIM team to bring this first-in-class treatment closer to patients," states George Oursler, Senior Vice President of Anterior Segment at Ora. "The PDSP technology platform is unlike any currently available treatment for dry eye, and the evidence for studies completed thus far show strong potential that BRM421 can repair the corneal damage and alleviate the DES symptoms rapidly. We are excited to leverage the deep expertise Ora has in bringing new ocular health therapies to market, to shape the upcoming Phase 3 trials for BRM421 and advance this novel DES therapy closer to approval."
"This new partnership builds on the success of our previous collaboration for Phase 2 trials and will help to speed the progression of BRM421 through late-stage clinical development towards regulatory filing. BRIM's translational science expertise, together with Ora's extensive and successful track record in ophthalmic product development, will undoubtedly accelerate our timelines. With this new agreement in place, we intend to initiate Phase 3 studies in Q4 this year and are thrilled at the prospect of bringing this potentially transformative treatment to patients sooner," said Dr. Haishan Jang, President & Chief Executive Officer of BRIM.
DES currently has no cure and requires continual disease management. Artificial tears with demulcents can retain surface moisture, and immune modulators can help control inflammation, allowing the body's natural healing processes to repair the damage. However, for moderate to severe patients, these treatments are often not enough to control discomfort unless there is a way to further speed up the healing process.
"Regenerative peptide, BRM421 has a unique mechanism of action which stimulates the proliferation and differentiation of corneal limbal stem cells, which as a result, speeds up corneal repair and heals ocular wounds in DES patients2. BRM421 is on track to become the first DES treatment with rapid and total relief," concluded Dr. Jang.
