The company will assess the safety, tolerability, and pharmacokinetics of TNX-201 in a healthy volunteers trial scheduled to be completed before the end of 2014.
IMH has a history of use as a prescription pharmaceutical in the US as a mixture of two mirror-image isomers, also called as a racemic mixture.
Racemic IMH was a drug efficacy study implementation (DESI) ingredient that has been marketed as prescription single-agent and combination drug products for the relief of tension and vascular headaches without an approved new drug application (NDA) for many decades.
Research carried out by the company shows that one isomer of IMH, TNX-201, is believed to be primarily responsible for the efficacy associated with racemic IMH for the treatment of headache.
In addition, TNX-201 may possess favorable safety and tolerability relative to both the other isomer and to the racemic mixture as well as potentially have an improved clinical profile as compared to the unapproved racemic IMH for headache indications.
Tonix chairman and chief executive officer Seth Lederman said the company is developing TNX-201 with the goal of providing a new prescription medication for the millions of US adults who suffer from episodic tension-type headache.
"For many, the existing treatment options are not adequately effective. Furthermore, all of the approved prescription drugs contain the barbiturate butalbital," Lederman said.
"Barbiturates are known to impair alertness, and carry risk of dependence and addiction.
"With TNX-201 to enter clinical development ahead of schedule, we expect to complete this first-in-man pharmacology and pharmacokinetics study before the end of this year."