Saniona, a leading biotech company in the field of ion channels, announces that the Mexican regulatory authority, Cofepris, has approved Medix's phase 3 clinical study for tesofensine in obese Mexican patients. This phase 3 study will include 372 patients at two sites in Mexico under the management of Medix. Medix expects to initiate the study following importation and subsequent release of the drug product. The trial is expected to be completed within two years from initiation.
"We are very excited about the collaboration with Medix. Their professional team has demonstrated a strong commitment to develop and commercialise novel treatment paradigms for overweight and obesity in Mexico where they have been market leaders for several years. This is probably the most important milestone for Saniona since we became operational in 2012," says Jørgen Drejer, CEO of Saniona.
The primary objective of this phase 3 study is to evaluate efficacy and safety of tesofensine in adult Mexican patients with obesity.
"The initiation of the phase 3 study for tesofensine in obesity represents an important step towards market approval. Tesofensine has shown outstanding weight loss in a phase 2 clinical study in obese persons. Tesofensine has been tested in more than 1,300 patients and was in general well tolerated. Therefore, tesofensine has the potential to become the preferred treatment option for an important health problem in Mexico," says Carlos López Patán, CEO of Medix.
This randomized, double-blind, placebo-controlled, parallel-arm, phase 3 clinical trial will include up to 372 ambulatory adult patients with obesity. The patients are randomized into three arms with 124 patients in each arm receiving either 0.25 mg tesofensine, 0.5 mg tesofensine or placebo tablets once daily. The study starts with a 2-week run-in period followed by 24 weeks treatment period.
The primary endpoint is absolute and percent change in body weight over the treatment period. Secondary endpoints include proportions of patients achieving a weight loss of more than 5 and 10 per cent respectively, metabolic including glycaemic endpoints, as well as quality of life, comprehensive tolerability and safety evaluation.
In February 2016, Saniona entered a collaboration with Medix about the development and commercialization of tesofensine and Tesomet in Mexico and Argentina. Medix has exclusive rights to develop and commercialize tesofensine and Tesomet in the two countries and will finance and be responsible for the clinical development and regulatory filings. Saniona retains all rights to tesofensine and Tesomet including the exclusive rights to use the clinical data developed by Medix in the rest of the world. Medix will pay Saniona regulatory milestone payments and double-digit royalties on product sales.
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.
Medix is a Mexican pharmaceutical company established in 1956. Medix is primarily focused on treatment of overweight and obesity.
Medix receives mexican regulatory, tesofensine, obese patients
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