THX Pharma (Theranexus) and Biocodex have entered a strategic licensing agreement to further the development of two drug candidates, Batten-1 and TX01, targeted at the Batten, Gaucher, and Niemann-Pick type C rare diseases.
Under the agreement, Biocodex will hold an exclusive worldwide licence to develop and commercialise Batten-1, which has been developed by THX Pharma for juvenile Batten disease (CLN3).
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Additionally, Biocodex will receive exclusive rights in Canada and the US to develop and commercialise TX01, a new formulation of an existing molecule for treating Niemann-pick type C and Gaucher diseases.
These are genetic disorders that result in severe neurological, visceral or haematological complications.
THX Pharma is set to receive total payments up to €173m ($206.1m). This includes an upfront payment of €12m and as much as €161m in milestone payments associated with development and commercialisation achievements.
Furthermore, the company will receive double-digit tiered royalties on net sales. It will lead clinical development with financial and scientific support from Biocodex, which will also handle market access and commercialisation within the licensed territories.
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By GlobalDataBatten-1 is being prepared for a Phase III trial scheduled to commence in 2026. Juvenile Batten disease (CLN3) is an ultra-rare neurodegenerative condition leading to cognitive decline, progressive vision loss, motor impairment, and early mortality. Currently, there are no approved treatments.
The goal is for Batten-1 to become the first available therapy for this indication, with a planned international launch by 2030. The Batten-1 programme originated with the Beyond Batten Disease Foundation.
TX01 utilises an adapted oral formulation of an already approved substance for Niemann-Pick type C disease and Gaucher disease type 1. The approach aims to enhance administration methods and better meet patients’ needs.
