NIC-001 is Nanologica’s in-house project within gastroparesis. In this project Nanologica’s platform is used to reformulate an approved API, metoclopramide (MCP), that in its existing formulation does not give the patients an optimized drug uptake. Reformulation of the API with Nanologica’s technology to a sublingual administration route is expected to lead to a more consistent absorption and increased efficacy of the drug.

Gastroparesis (delayed emptying of the stomach) is a disease mainly affecting diabetic patients. The symptoms include pain, nausea and vomiting. MCP is today the only drug approved by the FDA for the treatment of gastroparesis. MCP, which increase the gut motility and has a positive effect on emesis, is currently only available as an oral tablet or as injectable for hospital use.

The efficacy of current oral MCP-based drugs varies widely and, in some patients, have no effect, as the drug is administered into a malfunctioning gut system. By bypassing the malfunctioning gastrointestinal system through sublingual administration,  this issue is believed to be addressed. The expected advantage of NIC-001 is a faster and more consistent uptake of MCP, resulting in relief of symptoms and fewer side effects for the patients.

In the US approximately 2.3 million patients seek medical help for gastroparesis. About 2 million of these are women, whereof approximately half do not respond to available treatment options. The market is assessed to be growing as the number of diabetes patients are growing continually; the National Diabetes Statistics Report from 2017 reports that there are over 30 million people in the US suffering from diabetes.

The clinical trial Nanologica intends to carry out is a phase IIa cross-over study on gastroparesis patients with the aim of studying the safety of NIC-001 and comparing its pharmacokinetic profile to the formulation of metoclopramide available on the market today. The applications to gain approval to start the study is expected to be handed in during the first half of 2020.