Insero Health announces top-line Phase Ib trial results of INS001 in patients with drug-resistant epilepsy

May 17 2013

Insero Health, Inc., a company developing natural compounds to address unmet medical needs in epilepsy and related neurological disorders, is today reporting top-line results from a Phase Ib trial of its lead compound INS001 in patients with drug-resistant epilepsy. The data are being presented at the AntiEplileptic Drug and Device Trials (AED) Xll meeting by Dr. Steven Schachter , Harvard Medical School epileptologist and Chairman of Insero's Scientific Advisory Board. In this study, INS001 appeared safe and well tolerated.

INS001 is a naturally occurring compound that has shown promising activity in multiple preclinical epilepsy models. Insero researchers believe that INS001 exerts its anti-epileptic effects through a unique combination of mechanisms: it is both a potent acetylcholinesterase inhibitor and an NMDA-receptor antagonist. The compound has previously demonstrated good safety and signs of therapeutic activity in a Phase II trial in Alzheimer's disease, as well as in preclinical models of multiple sclerosis and neuropathic pain.

The Phase I trial was a single-center, inpatient, open-label, rapid dose escalation study in patients with drug-resistant epilepsy.  INS001 was safe and well tolerated at doses expected to be therapeutic, and increased cardiac parasympathetic tone and electrical stability were observed.

Dr. Schachter noted, "The positive safety demonstrated in this first trial of INS001 in drug-resistant epilepsy is a step forward in the clinical development of this therapy as a potential new treatment option for patients with epilepsy whose seizures are inadequately treated today."

Insero expects to initiate a Phase II proof of principle trial in patients with drug-resistant epilepsy by early next year.

Epilepsy affects about three million people in the U.S. and over 50 million people worldwide.  Many people with epilepsy take multiple medications, yet the published literature suggests that as many as one-third are unable to control their seizures with current therapies.  INS001 has a unique mechanism of action that suggests it could potentially provide superior efficacy either as a stand-alone therapy or when given in combination with other epilepsy drugs.