Insero Health Completes Phase I Trial of Novel Therapy in Patients With Drug Resistant Epilepsy

MIAMI, Dec. 13, 2012 /PRNewswire/ -- Insero Health, Inc., a company developing natural compounds to address unmet medical needs in neurological disorders, today announced that it has completed a Phase Ib trial of its lead compound INS001 in patients with drug-resistant epilepsy. Insero also reported that two key US patents licensed from Harvard University have issued, and the company announced the formation of its Scientific Advisory Board (SAB).

INS001, also known as huperzine A, is a naturally-occurring compound that has shown promising activity in preclinical epilepsy models. It has previously demonstrated good safety and signs of therapeutic activity in a Phase II trial in Alzheimer's disease and in preclinical models of multiple sclerosis and neuropathic pain.

The Phase lb epilepsy trial included dose ranging assessments, as well as biomarkers chosen to provide information on the potential therapeutic activity and cardioprotective properties of INS001. Insero expects to report the results of the Phase Ib trial in the next few months and to initiate Phase II proof-of-principle trials by early 2014.

Epilepsy affects about three million people in the United States 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 therapy. INS001 has a unique mechanism of action, which suggests it may provide superior efficacy either as a stand-alone therapy or when given in combination with other epilepsy drugs.

The two newly-issued patents were exclusively licensed to Insero by Harvard University and cover the use of INS001 as a treatment for epilepsy and other indications. The company also has licensed technology patents from Yale University and the University of South Florida. In addition, Insero is continuing its research programs related to its library of over 5,000 proprietary compounds, including screening for potential utility in epilepsy and other related neurological disorders.

The inventor of the newly-issued patents and Chairman of Insero's Scientific Advisory Board, Dr. Steven Schachter, is an eminent Harvard Medical School epileptologist and Chief Academic Officer of CIMIT, a non-profit consortium of Boston's leading teaching hospitals and universities. Dr. Schachter noted, "I am pleased that the first trial of INS001 in epilepsy is now complete. This is a significant milestone and step forward in the clinical development of this therapy with worldwide potential for patients with epilepsy."

Dr. Schachter and Insero also announced the membership of its SAB, which includes:

• Roger Porter, MD, Chief Scientific Officer of the Epilepsy Therapy Project and previously Chief of the Epilepsy Branch, Chief of the Medical Neurology Branch and Deputy Director of the US National Institute of Neurological Disorders and Stroke.
• Michael Rogawski, MD, PhD, Professor of Neurology at the University of California, Davis, and previously Chief of the Epilepsy Research Section at the US National Institutes of Neurological Disorders and Stroke.
• H. Steve White, PhD, Professor of Pharmacology and Toxicology at the University of Utah College of Pharmacy, and Principal Investigator and Scientific Director of the US National Institutes of Health-sponsored Anticonvulsant Drug Development Program.
• Seth Herzon, PhD, Assistant Professor of Chemistry at Yale University, whose research focuses on the synthesis and study of complex natural products and the development of new synthetic methods.

"We are awaiting detailed analyses of our first clinical trial of lead compound INS001 in patients with treatment resistant epilepsy, but top-line data from the trial have already provided us with valuable insights into the potential of this promising compound, which should enable us to advance it into Phase II studies with a good sense for likely dosing and potential activity parameters," commented David Kolb, CEO of Insero Health. "We are also delighted to announce the formation of our SAB, chaired by renowned neurologist and epilepsy opinion leader Steven Schachter. Dr. Schachter has helped us to assemble some of the most respected thinkers in the field, and we are honored to have these individuals working with us toward our goal of improving the lives of people with debilitating neurological diseases."

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 United States and over 50 million people worldwide. Insero researchers believe that the unique mechanism of lead product INS001 may provide enhanced anti-seizure efficacy without the side effects of current therapies. The company is based in Miami, Florida, at the University of Miami Life Science and Technology Park. For more information, visit www.inserohealth.com.

SOURCE Insero Health, Inc.