Claris Bio Emerges From Stealth With a New Investor and Prepares for Next Development Stage With Late-Stage Data Expected in 1H24

• Company Funded by Novo Holdings A/S, RA Capital, Mass General Brigham Ventures, Expands Syndicate With Financing from Janus Henderson Investors
  
• Lead Program, CSB-001, a Topical Ocular Biologic Solution of dHGF, Targets the Complete Healing of the Cornea Surface in Eyes with Neurotrophic Keratopathy (NK)
  
• Topline Data Expected in 1H24 From Late-Stage Study of CSB-001 in NK
  
• Leadership Team, with an Extensive Track Record and Deep Expertise in Ophthalmology Drug Development, Commercialization, and Partnerships, Brings Company from Pre-IND to Pivotal Data in Four Years

JERSEY CITY, N.J., Jan. 04, 2024 (GLOBE NEWSWIRE) — Claris Bio, a late-clinical stage biotechnology company focusing on corneal disease therapies, today unveiled the company and its lead program, with a total of $57 million invested from Series A investors Novo Holdings A/S, RA Capital and Mass General Brigham Ventures and recent investor, Janus Henderson Investors.

Claris, initially funded in 2020, is developing recombinant human variant hepatocyte growth factor, dHGF, to accelerate and improve the quality of corneal healing in patients with corneal eye disease. Its lead program, CSB-001 Ophthalmic Solution 0.1% (oremepermin-α), brings a topical ocular biologic solution of dHGF, a molecule with the potential to restore structural and functional corneal integrity, to eyes with neurotrophic keratopathy (NK). Oremepermin-α is epitheliotropic, neurotrophic, anti-inflammatory, and anti-fibrotic, suggesting it could be an efficacious and safe option to treat many current unmet needs in diseases of the cornea. Claris expects to complete enrollment in its late-stage multi-center, randomized, double-masked, vehicle-controlled, parallel-group study, with a data readout expected in 1H2024.

Beyond NK, Claris’ strategy is to create a pipeline by developing oremepermin-α across multiple ophthalmic diseases, greatly expanding the patient population that can benefit from its activity. Additional indications of interest that are being actively pursued by Claris, supported by preclinical and clinical data, include limbal stem cell deficiency and pre-existing corneal scar. Future potential indications include corneal injury, corneal ulcers, chemical burns, and persistent epithelial defects.  

“Our vision is to lead the way in corneal therapy by developing oremepermin-α into a pipeline that addresses the high unmet need in corneal disease. We are honored to have such a strong group of investors, as we approach a pivotal inflection point in our company’s growth,” said Claris Bio Founding CEO Clarke Atwell. “Topical oremepermin-α therapy has the potential to significantly impact several significant conditions of the cornea, with the potential to improve patients’ lives.”

In addition to Mr. Atwell, the Claris leadership team includes CMO Susan Orr, OD, and Chief Business Officer Henry Rath. Scientific cofounders include Dr. Reza Dana, MD, MSc, MPH, and Dr. Sunil Chauhan, DVM, PhD., both from the Massachusetts Eye and Ear and the Harvard Medical School Department of Ophthalmology.

“Claris Bio is developing what has the potential to be the new standard of care for numerous corneal diseases,” said Agustin Mohedas, Ph.D., Portfolio Manager, Janus Henderson Investors. “We are excited to be part of the next chapter in the company’s growth.”

Neurotrophic keratopathy, or NK, is a rare chronic degenerative disease caused by impairment of corneal sensory innervation. NK is characterized by decreased or absent corneal sensation (nerve damage), leading to epithelial breakdown, persistent wounds, scarring and ultimately the development of ulceration, melting, and perforation, and it is estimated that there over 100,000 patients with NK in the US.

About Oremepermin Alfa

Oremepermin alfa is the International Nonproprietary Name of the five amino acid-deleted variant of hepatocyte growth factor (dHGF). Recombinant human dHGF was originated and is currently being developed by Kringle Pharma, Inc. a late-clinical stage biopharmaceutical company, for the treatment of incurable diseases such as acute spinal cord injury and vocal fold scar. Claris and Kringle formed a partnership in 2020 where Claris secured all rights to oremepermin alfa in ophthalmic indications worldwide.

About Claris Bio

Claris Bio, based in Jersey City, NJ, was founded by a group of experienced biopharma industry executives and experts in ophthalmology. The company’s foundational intellectual property is based on work done at the Massachusetts Eye and Ear Infirmary by Dr. Reza Dana, MD, MSc, MPH, Claes Dohlman Chair in Ophthalmology, Harvard Medical School and Senior Scientist and Director of Cornea at Mass Eye and Ear and Dr. Sunil Chauhan, DVM, PhD, Principal Investigator and Associate Professor, Mass Eye and Ear, Harvard Medical School. Claris’ lead program, CSB-001 Ophthalmic Solution 0.1%, brings a topical ocular biologic solution of oremepermin-α, a molecule with the potential to restore structural and functional corneal integrity, to eyes with neurotrophic keratopathy (NK). For more information about Claris, please visit www.clarisbio.com.

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