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Kiora Pharmaceuticals, Inc. (NASDAQ:KPRX) ("Kiora" or the "Company") today announced it has granted Senju Pharmaceutical Co., Ltd. (Senju) an exclusive option to exercise rights to an exclusive development and commercialization agreement for KIO-301 for the treatment of ophthalmic diseases. The agreement will cover key Asian marketplaces, including Japan and China.
"Like elsewhere in the world, patients in Asia with inherited retinal diseases, including retinitis pigmentosa, have no therapeutic options to slow their disease progression nor restore what has already been lost. KIO-301 is a very promising, novel therapeutic with the potential to give vision back to affected individuals. We are extremely excited to partner with Kiora and work collaboratively to bring this promising candidate to this underserved community," said Shuhei Yoshida, President of Senju.
Under the terms of the agreement, Senju has a defined period to enter into an exclusive development and commercialization agreement. This window begins after topline data from the ongoing ABACUS-2 Phase 2 clinical trial is reported. This structure affords Senju an opportunity to collaborate with Théa Open Innovation (Laboratoires Théa or Théa), Kiora's exclusive global development and commercialization partner for KIO-301 outside of Asia.
"This option agreement represents a critical step toward establishing a long-term strategic partnership with Senju and extends the global commercial reach of KIO-301 by building on the foundation established by Théa," said Brian Strem, PhD, CEO of Kiora. "As a leading ophthalmic pharmaceutical company in Asia, Senju's interest in KIO-301 reinforces the need and opportunity for new treatments for inherited retinal conditions like retinitis pigmentosa (RP), and other retinal diseases."
The key terms and conditions of the exclusive development and commercialization agreement have been agreed to, subject to Senju exercising its option. Under the development agreement Senju would be responsible for all development, regulatory, and commercial activities in the licensed territory. Additional terms include country-specific regulatory and commercial milestones as well as tiered royalties on net sales.
In January 2024, Kiora and Théa entered into their ongoing exclusive worldwide co-development and commercialization agreement, excluding Asia, for KIO-301 in the treatment of retinal diseases. Under the combined relationships with Théa in 2024 and the new relationship with Senju, the total potential value of strategic partnerships exceeds $400 million, plus significant royalties on sales.
KIO-301 is currently in a Phase 2 clinical trial, ABACUS-2, a multi-center, double-masked, randomized, controlled, multi-dose study in 36 patients with ultra-low vision or no light perception due to RP. KIO-301 is a new type of therapy under development for inherited retinal diseases that acts as a "molecular photoswitch." Many inherited retinal diseases, including RP, cause the eye's light-sensing cells (rods and cones) to degenerate, leading to vision loss. KIO-301 targets surviving cells in the retina (the Retinal Ganglion Cells or RGCs), which connect the eye to the brain. The molecule enters these RGCs and, when activated by light, allows them to send signals to the brain, aiming to restore visual function.
This agreement further strengthens Kiora's balance sheet and supports the Company's expected cash runway into late 2027, beyond the projected readout of Kiora's two ongoing Phase 2 clinical trials.
Posted In: KPRX
