Arecor Ltd, the specialty pharmaceutical company leveraging its innovative and proprietary formulation technology to develop superior treatments for a range of disease areas, including diabetes, today announces that a Phase I Clinical Trial Application (CTA) for product candidate AT247 has been approved by the Bundesamt für Sicherheit im Gesundheitswesen (BASG), the Austrian Federal Office for Safety in Health Care.
Arecor receives regulatory approval to initiate Phase I clinical trial for insulin product
Arecor’s AT247 is an ultra-rapid acting prandial insulin product candidate targeting improved treatment for people living with Type I diabetes. Prandial insulin is used in the management of diabetes to control the rise in blood glucose after meals. The novel formulation of AT247 is designed to deliver an acceleration of insulin absorption post injection. This enables more effective management of blood glucose levels to ensure lower variability of post-meal blood glucose elevations and the potential clinical benefits of avoiding both hypoglycaemia and hyperglycaemia.
The double-blind, randomised, three-way cross over study will compare the pharmacokinetic and pharmacodynamic profiles of AT247 to current best in class insulin treatments. The trial is being conducted in Austria at an internationally recognised centre of excellence in the field of diabetes research.
Sarah Howell, Chief Executive Officer at Arecor said, "We are pleased that the CTA has been approved to enable a clinical study of AT247. We believe that this product candidate meets a recognised need to develop faster acting insulins to further improve the lives of people managing Type I diabetes. This is an important milestone for Arecor and we look forward to providing further updates as AT247 progresses through clinical development.”
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