Tonix Pharmaceuticals and Inserm, which is the French National Institute of Health and Medical Research, have entered into a licensing agreement in which Tonix will hold the license to oxytocin-based therapies for the treatment of Prader-Willi syndrome (PWS). Under this agreement, Tonix will grow its program to include TNX-2900.
About Prader-Willi Syndrome
Prader-Willi syndrome (PWS) is a rare, genetic disorder that is characterized by a constant sense of hunger (hyperphagia). This hunger begins at age two. Physical, mental, and behavioral problems are all common in those with this syndrome. People may experience intellectual impairments and learning disabilities. An error in one or more of the genes on chromosome 15 causes this condition. These errors disrupt the function of the hypothalamus, which is the part of the brain that is responsible for releasing hormones. It is typically a sporadic mutation that leads to the errors on chromosome 15.
Symptoms of Prader-Willi syndrome will change as people age. Right after birth, symptoms include poor muscle tone, distinctive facial features like a narrow forehead, almond-shaped eyes, and a triangular mouth; poor sucking reflex, poor responsiveness, and underdeveloped genitals. As a child reaches early childhood, symptoms may change to hyperphagia, poor growth and physical development, cognitive impairment, delayed motor impairment, obesity, speech and behavioral problems, short stature, small hands and feet, and sleep disorders. Treatment is symptomatic, and it includes good nutrition, human growth hormones, weight management, sex hormone treatment, behavioral and physical therapy, and sleep disorder treatment.
About the Agreement
The agreement has given Tonix a co-exclusive license is in regards to the intranasal potentiated oxytocin development program, which is now expanding to include TNX-2900. As of now, patents for this technology will give market exclusivity through 2031 in both the United States and throughout Europe.
With this agreement aiding further development of the technology, Tonix hopes to submit their applications for the Fast Track and Orphan Drug designations to the FDA. Researchers have found that their therapies have the ability to treat not only suckling in newborns, but hyperphagia in adults as well.
This therapy utilizes intranasal potentiated oxytocin formula. Looking specifically at oxytocin, it is a hormone that plays the role of a neurotransmitter in the brain. This technology has been used to treat chronic migraines, help women produce breast milk, and induce labor.
Previous success of this technology gives researchers confidence that TNX-2900 will face similar success. As Prader-Willi syndrome patients currently face an unmet medical need, this success is very important.
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