Kiora adds Senju's oral retinal drug to pipeline and drops KIO-104 spending

Kiora Pharmaceuticals is reworking its pipeline. In its third-quarter update on 12 November, the company said it had secured exclusive rights outside Asia to KIO-401, also known as mitucapistat, from Japan's Senju Pharmaceutical. The oral calpain inhibitor is aimed at central retinal artery occlusion (CRAO). In the same update Kiora said it had stopped investing in another programme, KIO-104.

The regulatory plan is at an early stage. Kiora has asked the US Food and Drug Administration for a pre-IND meeting and for orphan drug designation, and it intends to run one multinational Phase 3 study intended to support registration. As general context, orphan status is a US mechanism designed to encourage development of treatments for rare conditions, and a pre-IND meeting lets sponsors test their plans with the agency before filing. No dates for the meeting or a designation decision were given in the material available, nor were the financial terms of the Senju agreement or the design of the trial.

The company's finances show how small the operation is. Kiora reported about $16.3 million in cash and a net loss of roughly $1.7 million for the quarter. A single registration trial is a more economical plan than a multi-study programme, but the available material does not say how the company intends to fund it.

Kiora's other assets are also split by territory. Its Phase 2 ABACUS-2 trial of KIO-301 is continuing, and South Korean rights to that candidate are licensed to Chong Kun Dang. KIO-401 rights are held outside Asia, so territory arrangements for the two assets are separate.