Oculis and Accure Therapeutics have announced a licensing agreement granting Oculis exclusive global rights to develop and commercialize ACT-01, a potentially disease-modifying therapy to protect and prevent damage to the optic nerve and retina.
ACT-01, which is being renamed OCS-05, is a first-in-class small molecule with neuroprotective activity that has shown positive results in animal models of neuroinflammation and neurodegeneration. Its mechanism of action is related to the activation of the trophic factor pathways such as IGF-1 and BDNF. In ophthalmology, this action can protect the nerve axons in conditions where the optic nerve is affected, such as in acute optic neuritis and glaucoma, where the OCS-05 could prevent chronic vision loss, Oculis said in a press release.
Based on positive preclinical data and results of a phase I safety and PK study in healthy volunteers, a phase 2a study was initiated (the ACUITY study), the company explained.
Oculis is currently planning the expansion of the program in ophthalmology working with the regulatory agencies in the US, EU and China amongst others, the company said.
Riad Sherif, M.D., CEO of Oculis, said: “We are excited about this agreement as it combines Oculis’s ophthalmology expertise with Accure’s unique neuroprotective approach to help transform the treatment of neurodegenerative diseases in ophthalmology. At Oculis, our focus is on building a highly innovative and differentiated pipeline providing life changing treatments for ocular unmet medical needs, and OCS-05 is a perfect fit for that ambition. Glaucoma is a leading global cause of irreversible blindness, and despite IOP lowering treatments, a significant proportion of patients still go blind. With OCS-05, we have the potential to bring to market the first neuroprotective for glaucoma and other optic neuropathies.”
Laurent Nguyen, M.D., Co-founder and Chief Executive Officer at Accure Therapeutics, said: “Having shown promising early data and potential in a number of ocular disease indications, the timing is right for a partnership between two like-minded companies committed to patients and driven by a passion for neuroscience. By leveraging its expertise in ophthalmology, Oculis has the potential to fulfill the promise of this exciting asset in a wide range of neurodegenerative diseases.”
Under the terms of the agreement, Accure Therapeutics will receive an upfront payment, potential milestone payments upon the achievement of certain development and commercial milestones, and tiered royalties on sales, the company said.