Under the terms of the agreement, Kiora Pharmaceuticals and Théa Open Innovation will develop and commercialize KIO-301 for the treatment of inherited retinal diseases in a deal valued at up to $301 million.
Kiora Pharmaceuticals Inc announced it has entered a strategic development and commercialization agreement with Théa Open Innovation (TOI), a sister company of the global ophthalmic specialty company Laboratoires Théa.
According to a news release,1 under the agreement, Kiora granted TOI exclusive worldwide development and commercialization rights, excluding Asia, to KIO-301 for the treatment of degenerative retinal diseases.
In exchange, Kiora will receive an upfront, payment of $16 million; up to $285 million upon achievement of pre-specified clinical development, regulatory and commercial milestones; tiered royalties of up to low 20% on net sales; and reimbursement of KIO-301 research and development expenses.1
Brian Strem, PhD, CEO of Kiora, noted that the company’s partnership with TOI provides it with the strategic, financial and commercial resources that can help to bring innovative treatments to market for patients living with inherited retinal disease.
“Based on the Phase I/II (ABACUS) data of KIO-301 in Retinitis Pigmentosa (RP), we have started to implement our plan to initiate our Phase 2, multicenter, controlled clinical trial for retinitis pigmentosa, in early 2024 with the goal of reporting results in H1 2025 and explore other retinal disease where KIO-301 may be applicable,” he said in the news release.
Data from ABACUS, reported in November 2023,2 demonstrated meaningful vision improvements in patients with late-stage RP. Findings included significant improvement in visual field, concordant trended improvements in visual acuity and tests of functional vision relating to the use of sight in everyday activities. In addition, according to the November news release, functional MRI demonstrated increased visual cortex activity (region of the brain responsible for processing vision) relative to baseline at two and 14 days after treatment.
“This partnership confirms our commitment to advancing innovation in the treatment of unmet need for ophthalmic diseases,” Jean-Frédéric Chibret, president of the Théa group, said in the news release.
Chibret pointed out in the news release that KIO-301 fits ideally into his company’s range of therapeutic solutions as a cutting-edge product intended to return vision to patients suffering from hereditary retinal diseases thanks to an innovative small molecule.
“Promising clinical trial results recently reported at the American Academy of Ophthalmology meeting on KIO-301 give us further confidence in the program and the potential to bring a new treatment option to patients suffering from rare diseases,” he concluded in the release.
The strategic partnership covers retinitis pigmentosa and potentially other indications in ophthalmology across all global geographies, excluding China, Japan, and certain other countries in Asia. Kiora is primarily responsible for the design and implementation of clinical development through phase 2 whereas Théa will assume primary responsibility for phase 3 clinical trials as well as for securing regional marketing authorizations. Upon approval in respective regions, Théa will be responsible for all commercial activities including sales, marketing and market access.1
According to the company,3 KIO-302 is a small molecule, referred to as a molecular photoswitch, designed to confer light-sensing capabilities to retinal ganglion cells (RGCs). In healthy eyes, light detection is primarily performed by photoreceptors (rods and cones). In patients with numerous types of inherited retinal disease, mutations in one of more than hundreds of known genes can lead to the death of photoreceptors.
Moreover, the company noted the retinal degeneration results in lost vision for the patient. KIO-301 is able to selectively enter RGCs downstream of degenerated photoreceptors and once inside, KIO-301 interacts with voltage-gated ion channels. When light hits RGCs, KIO-301 alters its shape to change the flow of current, thereby activating the neurons, and resulting in signaling the brain. When light is removed, KIO-301 reverts to its lower energy shape, stopping the signaling to the brain. In this way, the molecule acts as a light switch within the eye.3