Clinical

Clinical Development

Following the completion of the remaining pre-IND application enabling studies, the Company proposes to seek regulatory approval from the US Food and Drug Administration to take the lead compound ETI-385 into permitted human proof-of-concept Phase-1/2 clinical trials in the United States. The Company intends to investigate ETI-385 in end-of-life, terminally-ill patients in a palliative care setting. These patients often encounter uncontrolled nausea and vomiting, and there are limited-to-no effective treatment options for these patients. The Company has secured relationships with a leading palliative care site that has experience in conducting on-site clinical studies, and has the infrastructure and staff with expertise and experience in conducting clinical studies. The lead clinical investigators have agreed to conduct these studies at a substantially reduced financial rate. In addition, the site is able to conduct on-site formulation and has agreed to do so, also saving the Company significant costs. A clinical trial protocol-synopsis, plan and budget have already been developed. Because these costs are substantially reduced, the investment requirements of the Company are significantly reduced. The Phase 1/2 clinical trial is anticipated to incorporate exploratory translational medicine efficacy components which are intended to assist the Company with the development of further compounds for additional treatment situations (for example, motion sickness, chemical-induced emesis, etc.). Based on the outcome of these studies, as predicated upon the unmet needs in this patient population, the Company and its advisers believe that the opportunity exists to move the development of ETI-385 into registration studies seeking regulatory approval for the marketing and sale of ETI-385. The Company expects that it will take approximately 18 months from inception to completion of the Phase 1/2 proof of concept study.