Strategic alliance combines resources to develop treatment option for dry eye syndrome

BRIM Biotechnology Inc. has entered into a new strategic partnership with Ora Inc. for the late-stage clinical development of lead drug candidate BRM421 for dry eye syndrome (DES).

According to a news release, BRIM intends to initiate Phase 3 clinical studies with Ora’s support later this year.

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 worldwide.¹ 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, 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.

George Ousler, senior vice president anterior segment at Ora, noted that the company has been passionate about addressing the challenges of DES and honoured to be working with the BRIM team to bring this treatment closer to patients.

“The PDSP technology platform is unlike any currently available treatment for dry eye, and the evidence from studies completed thus far show strong potential that BRM421 can repair the corneal damage and alleviate the DES symptoms rapidly,” he said in the news release. “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.”

Dr Haishan Jang, president and CEO of BRIM, explained that the new partnership builds on the success of the companies’ 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,” she said in the news release. “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.”

DES currently has no cure and requires continual disease management. Artificial tears with demulcents can retain surface moisture and immune modulators can help to control inflammation, allowing the body’s natural healing processes to repair damage. However, for moderate to severe patients, these types of 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 patients.² BRM421 is on track to become the first DES treatment with rapid and total relief,” concluded Dr Jang.

References

1. Dry Eye disease clinical markets 2021-2029: Marketed and Pipeline Drugs, clinical trials, upcoming and regulatory events, epidemiology, licensing and acquisition deals, drug revenues. Dry Eye Disease Clinical Markets 2021-2029: Marketed and Pipeline Drugs, Clinical Trials, Upcoming and Regulatory Events, Epidemiology, Licensing and Acquisition Deals, Drug Revenues. https://www.prnewswire.com/news-releases/dry-eye-disease-clinical-markets-2021-2029-marketed-and-pipeline-drugs-clinical-trials-upcoming-and-regulatory-events-epidemiology-licensing-and-acquisition-deals-drug-revenues-301328151.html.

2. Ping-Yen Yuang, MD, Yeou-Ping Tsau, et.al; Topical BRM421 Ophthalmic Solution improves signs and symptoms of moderate to severe dry eye patients in clinical trials. Investigative Ophthalmology & Visual Science June 2021, Vol. 62, 1335.