Saniona provided a tesofensine update
Last week, Saniona announced that its partner Medix in Mexico had not received regulatory approval for tesofensine. In a new update, Saniona clarifies that Medix, as the primary applicant and manager of the approval process in Mexico, is actively engaging with the regulatory agency to resolve the matter.
Saniona’s pipeline primarily targets epilepsy and other neurological disorders. Yet, its most advanced candidate is Tesofensine, developed to treat obesity.
Tesofensine modulates brain activity by increasing the levels of three neurotransmitters – dopamine, serotonin and noradrenaline that play a central role in regulating appetite, food-seeking behaviour and metabolism.
Tesofensine’s weight loss potential
In June, Karin Sandager Nielsen, CSO of Saniona commented on the potential mechanism of action behind tesofensine’s weight loss effect, based on an article published in PLOS One by an obesity research group led by Ranier Gutierrez at the National Polytechnic Institute in Mexico:
“These data strongly support the promotion of tesofensine as a novel effective treatment for weight loss in obese people. The experiments demonstrate strong experimental skills and scientific experience of the responsible scientists and their excellence in the field. The techniques used are highly sophisticated and well suited for demonstrating tesofensine’s effects at specific neuronal pathway levels and brings us closer to understanding the cellular and network mechanism of action of tesofensine’s unique efficacy.” Read the full statement here.
The collaboration with Medix
In 2017, Saniona’s partner, Medix, initiated a phase III clinical trial of tesofensine in obesity. One year later, the trial was finalized and the conclusions were clear – both primary and secondary endpoints were met, statistically and clinically showing significant weight loss for two doses of tesofensine compared to placebo.
Tesofensine has since been progressing towards regulatory approval in Mexico through its commercial partner Medix. In 2023, the Mexican regulatory authority Cofepris provided a favorable opinion on tesofensine for treating obesity. In a press release, Saniona withheld that the opinion did not represent neither a market authorization nor a rejection — rather a non-binding technical opinion, issued as one of the steps in reviewing new molecules.
Medix in dialogue with regulatory authorities
The regulatory application is based on a phase III program with tesofensine involving 372 patients with an average weight loss of about 10 per cent in 24 weeks
Last week, Cofepris announced it had reached a decision regarding the approval of tesofensine, prompting a positive market reaction that saw Saniona’s stock price rise by 34 percent. However, it was later revealed that Cofepris had actually withheld approval, causing the stock price to drop sharply. At the time of writing, the stock trades 28 percent lower compared to its level prior to the Cofepris announcement.
Saniona responded to the news by stating that Medix had initiated discussions with the agency to determine the path forward. In a new press release, the company confirmed that Medix actively engages with Cofepris and remains fully committed to finding a solution. Out of respect for the ongoing process, Saniona has chosen not to provide further comments at this time.
However, some clarification was offered in today’s press release:
“Saniona’s November 6 press release was based on a very brief update from Medix. Since then, and after a more thorough review of the communication between COFEPRIS and Medix, Saniona has come to understand that the agency may not yet have completed a comprehensive assessment of the data package submitted. Thus, Medix and Saniona believe that COFEPRIS may not yet have reviewed the entire application package submitted by Medix.”
Saniona also emphasized that, while acknowledging the importance of transparency for its stakeholders, Medix is the applying entity and manages the process based on its expertise in the Mexican market conditions and regulatory landscape. Meanwhile, Saniona’s role is to support Medix in these efforts.
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