Kiora Pharmaceuticals, Inc. and Théa Open Innovation have entered into a strategic development and commercialization agreement involving Kiora’s KIO-310 for the treatment of degenerative retinal diseases.
Give me a rundown on these companies.
As a sister company of Laboratoires Théa, Théa Open Innovation identifies, evaluates, and supports eyecare developments via establishing license agreements and/or capital investments with key strategic partners.
Kiora is a clinical-stage biotechnology company headquartered in Encinitas, California, and focused on developing and commercializing therapies for treating orphan retinal diseases.
Of interest: In August 2023, the company announced a significant shift in its clinical development pipeline to focus solely on rare retinal disease candidates (KIO-100, KIO-104, and KIO-301).
Now KIO-301.
A visible light-sensitive small molecule (called a “molecular photoswitch”), KIO-301 is designed as a reversible photoswitch with the potential to restore the eye’s ability to perceive and interpret light in visually-impaired retinitis pigmentosa (RP) patients.
How does it work?
The therapeutic is intended to specifically enter photoreceptors’ key downstream retinal cells—bipolar and retinal ganglion cells (RGCs)—and turn them into light-sensing cells capable of notifying the brain of the presence / absence of light.
And the latest clinical data?
Back in May 2023, Kiora reported favorable preliminary data from the ongoing, open-label, dose-escalating phase 1b ABACUS study (NCT05282953) that assessed KIO-301 for RP in two cohorts and 4 dose levels.
The findings suggested that the initial low dose of KIO-301 has a favorable safety profile, considered well-tolerated, and capable of potentially improving light perception in patients with ultra-low vision (ULV) or blindness.
Gotcha. Now we can talk about this agreement.
Per the agreement, Théa will own the exclusive global (minus Asia) development and commercial rights to KIO-301, covering RP and potentially other ophthalmic indications.
In turn, Kiora will receive the following:
- An upfront payment of $16 million
- Up to $285 million after KIO-301 achieves pre-clinical development, regulatory, and commercial milestones
- Tiered royalties of up to 20% on net sales
- Reimbursement of KIO-301 research and development expenses
What else?
The “strategic partnership” also dictates that Kiora will be primarily responsible for clinical development design and implementation through phase 2.
Théa, on the other hand, will be largely responsible for phase 3 clinical trials + securing regional marketing authorizations for KIO-301.
Pending product approval in each region, “Théa will be responsible for all commercial activities including sales, marketing, and marketing access.”
So why partner on this asset?
According to Jean-Frédéric Chibret, president of the Théa group, KIO-301 is an ideal fit with the company’s range of therapeutic solutions.
Additionally, this partnership is just the latest exclusive licensing agreement for Théa in the last few months; see here for details on its collaboration with Ling Biologics Limited to develop a novel therapeutic agent for dry eye disease (DED).
The company’s other collaborations can be found here.
Lastly … what’s next?
"Based on the phase 1/2 (ABACUS) data of KIO-301,” stated Kiora CEO Brian Strem, PhD, “we have started to implement our plan to initiate our phase 2, multicenter, controlled clinical trial for retinitis pigmentosa early 2024.”
The goal, according to Strem, is to report results in the first half of 2025 and explore other retinal diseases where KIO-301 may be applicable.