Augustine Therapeutics NV (“Augustine” or “the Company”), a biotechnology company focused on developing new therapies for neuromuscular, neurodegenerative and cardio-metabolic diseases through the inhibition of the cytosolic Histone DeACetylase 6 (HDAC6) enzyme,announces it has dosed the first patient in its Phase I clinical trial evaluating lead candidate AGT-100216, the first peripherally-restricted, selective HDAC6 inhibitor (HDAC6i) for the treatment of Charcot-Marie-Tooth disease (CMT).

The Phase I trial is a randomized, double-blind, placebo-controlled, first-in-human trial, designed to evaluate the safety, tolerability, pharmacokinetics and exploratory pharmacodynamics of oral AGT-100216 in healthy adult volunteers. The trial is a combined two-part study evaluating single ascending and multiple ascending doses of AGT-100216.

Gerhard Koenig, PhD, CEO of Augustine, said: “The initiation of our first clinical trial is a major milestone for Augustine. Decades of research have validated the therapeutic potential of HDAC6 as a target but efforts to drug it to date have been sub-optimal. Augustine is developing a new generation of HDAC6 inhibitors, like AGT-100216, with a unique mechanism of action shown to be selective, safe and effective in pre-clinical trials. Having recently raised EUR 78 million / USD 85 million in an oversubscribed Series A financing round, and with a strengthened management team, the Company is entering a new stage of growth. We are well positioned to progress AGT-100216 through clinical development for CMT and to also advance our pipeline of next-generation HDAC6 inhibitors in significant cardio-metabolic and neurodegenerative diseases.”