Insero Health, a clinical-stage company that develops small molecule therapies derived from natural products to treat neurological diseases, has completed a phase Ib trial of its lead compound INS001 in patients with drug-resistant epilepsy.
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 Ib 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.
Insero also reported that two key U.S. patents licensed from Harvard University have issued. The two 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.