Saniona AB (STO:SANION), a biotechnology company in the field of ion channels, announced on Thursday the completion of recruitment by Medix, its partner in Mexico, for its phase 3 clinical study of tesofensine in obesity.
This trial is expected to be completed in 2018 and topline data is expected by early 2019.
According to the company, it is very pleased by its partner's rapid recruitment, which was completed within an impressive five months. It is optimistic about completing and reporting topline data by early 2019, almost one year earlier than originally announced.
This randomised, double-blind, placebo-controlled, parallel-arm, phase 3 clinical trial includes 372 ambulatory adult patients with obesity.
In February 2016, Saniona had entered into a collaboration with Medix for the development and commercialisation of tesofensine and Tesomet in Mexico and Argentina. Medix has exclusive rights to develop and commercialise tesofensine and Tesomet in these two countries. Medix will finance the studies and be responsible for the clinical development and regulatory filings.
Under this agreement, Medix will pay Saniona regulatory milestone payments and double-digit royalties on product sales in Mexico and Argentina. Saniona retains all rights to tesofensine and Tesomet in the rest of the world, including the exclusive rights to use the clinical data generated by Medix.
Saniona is a research and development company focused on drugs for diseases of the central nervous system, autoimmune diseases, metabolic diseases and treatment of pain.
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