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Insero Health Reports Positive Data on Phase I Trial of Novel Therapy for Drug-Resistant Epilepsy


5/17/2013 8:44:25 AM

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MIAMI, May 17, 2013 /PRNewswire/ -- 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.

The Antiepileptic Drug and Device Trials (AED) XII Conference is sponsored by the Epilepsy Study Consortium in collaboration with the University of Pennsylvania Epilepsy Center and the Epilepsy Therapy Project, an initiative of the Epilepsy Foundation. For more information, visit www.epilepsy.com/etp/aedtrialxii.

About Insero Health

Insero Health is a clinical-stage company that discovers and develops small molecule therapies derived from natural products to address significant unmet needs in neurological diseases. The company's initial target is epilepsy, a debilitating disorder that affects approximately 3 million people in the U.S. and over 50 million people worldwide. The company is based in Miami, Florida, at the University of Miami Life Science and Technology Park. For more information, visit www.inserohealth.com.

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