Tonix Pharmaceuticals has licensed technology from the French National Institute of Health and Medical Research (Inserm) that it aims to use for treating failure to thrive in Prader-Willi syndrome.
Oxytocin is a hormone that helps to send signals within the brain. Sometimes called the “love hormone,” oxytocin signaling plays key roles in the formation of romantic attachments, while also having a crucial function in energy expenditure and body weight. That Tonix’s formulation of oxytocin is “potentiated” means that it has a more potent effect than the naturally-occurring hormone.
In animal models, oxytocin treatment improves suckling in newborns and reduces feeding in adult animals. As such, it may be effective for treating PWS, which is characterized by reduced suckling in infancy and abnormal hunger (hyperphagia) later in life.
“Prader-Willi syndrome is a rare genetic disorder of failure to thrive in infancy and uncontrolled appetite and obesity in childhood and adulthood with no approved treatments available,” said Seth Lederman, MD, president and CEO of Tonix.
“With the license from Inserm Transfert [the private subsidiary of Inserm], we have the opportunity to expand our ongoing efforts with intranasal potentiated oxytocin to this new indication [PWS],” Lederman said.
Tonix’s formulation of intranasal potentiated oxytocin for the treatment of PWS has been dubbed TNX-2900. The company also is developing a different intranasal formulation and device, called TNX-1900, as a preventive therapy for chronic migraine and for the treatment of insulin resistance and related conditions.
“Since Prader-Willi syndrome is an orphan disease that occurs in approximately one in 15,000 births, we plan at the appropriate time to submit an application to the U.S. Food and Drug Administration [FDA] for Orphan Drug and Fast Track designations for TNX-2900,” Lederman said. Notably, these designations are intended to support the development of potential therapies through waivers of fees, a period of marketing exclusivity, the possibility of priority review, and more frequent contact with the FDA.
According to Tonix, the patents covering the newly licensed technology are expected to provide market exclusivity in the U.S. and Europe through 2031, with subsequent extensions possible.
In the U.S., an injectable formulation of oxytocin is approved for the induction of labor at the end of pregnancy; it is sold under the brand name Pitocin.
An intranasal formulation of oxytocin called Syntocinon was previously marketed in the U.S. by Novartis to aid in the production of breast milk, but that product has been withdrawn.
The licensing agreement was negotiated by Inserm Transfert on behalf of Inserm, Aix-Marseille Université, and the Centre Hospitalier Universitaire of Toulouse. None of the terms of the agreement were released.
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