Gubra submits clinical trial application (CTA) for first-in-human amylin trial
Gubra announces that a clinical trial application (CTA) for the anti-obesity amylin project has been submitted to the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. The clinical trial is expected to receive approval from the MHRA later in 2023 and the first human dose is planned for end of 2023.
Niels Vrang, Chief Scientific Officer at Gubra A/S, is excited with the progress of the amylin project (GUC17):
“This is the first drug project Gubra has progressed on its own to the clinic and I am of course excited not only for reaching this milestone but also extremely proud that we stick tightly to our timelines. Adding the capability to progress promising peptide drugs into early clinical drug development is a significant addition to the Gubra discovery engine. Our GUC17 amylin analogue is a potent and long-acting amylin-receptor agonist designed for weekly dosing, and we look forward to moving this potential anti-obesity drug in to the clinic. Our aim is to partner this programme during or after early clinical development.”
The planned phase 1 trial is a placebo-controlled dose escalation study testing single increasing subcutaneous doses of the novel long-acting amylin agonist GUC17. Participants in the trial will be healthy men with overweight/obesity. The primary objective of the trial is to investigate safety of GUC17. The trial will also evaluate the pharmacokinetic (absorption and distribution) profile of GUC17 and early signs of energy intake and metabolism of the test drug.