Tonix Cleared to Propel Migraine Therapy into Phase II


The Food and Drug Administration (FDA) has cleared the way for Tonix Pharmaceuticals to begin a Phase II study of its therapeutic candidate, which intends to prevent migraine headaches.

Tonix expects to begin enrollment in the trial for TNX-1900, an intranasal potentiated oxytocin, during the second half of 2022. Tonix believes that TNX-1900, which works by stimulating oxytocin receptors in the trigeminal ganglia, can help migraine sufferers.

“We are excited to have received the FDA’s IND clearance to begin clinical trials for TNX-1900 in prevention of migraine headaches in chronic migraineurs,” said Tonix President and CEO Dr. Seth Lederman, M.D.

To be diagnosed as a “chronic migraineur,” one must suffer a migraine headache on a minimum of 15 days each month for at least three consecutive months and experience moderate-to-severe pain on one side of the head that causes a pulsing sensation on the affected side. These headaches may also be made worse by routine physical activity. The condition impacts an estimated four million people in the U.S. alone. For those patients, Tonix may soon have another option.

TNX-1900 is a drug-device combination based on an intranasal actuator device that delivers oxytocin into the nose. As such, the company expects the therapy to qualify for the 505(b)(2) pathway for FDA approval. This pathway is intended for new formulations of an already-approved drug. Lederman added that Tonix also plans to develop TNX-1900 for craniofacial pain and insulin resistance.

Tonix acquired the asset in 2020 from Trigemina, Inc, a pharmaceutical company researching pathways to develop treatments in acute and chronic pain. The therapy was also licensed from Stanford University.

In his statement, Lederman highlighted another potentiated oxytocin product candidate, TNX-2900, which is under development to treat of Prader-Willi syndrome.

Prader-Willi syndrome (PWS), a genetic condition, begins in infancy and impacts several parts of the body, causing low muscle tone, feeding difficulties, and slow growth. Affected children typically become obese due to excessive eating. It is caused by missing or non-working genes on chromosome 15 and is usually not inherited. TNX-2900 is currently being investigated in IND-enabling studies.

Tonix, based in New Jersey, has a CNS pipeline that includes investigational drugs for conditions such as fibromyalgia, long COVID, post-traumatic stress disorder, depression, and cocaine overdose.

It’s been a busy second half for Tonix. In August, its stock surged after it announced plans to initiate a Phase II study of TNX-102 SL as a potential treatment for long COVID. The study will leverage insights already learned about the pharmacodynamic activity of the drug from fibromyalgia trials.

Back to news