Today, Gubra announces that the first human subject has been dosed with a new long-acting amylin agonist (GUBamy) as a potential treatment for obesity. This first clinical trial is a single ascending, dose-escalation, safety, and tolerability trial in healthy volunteers.
“GUBamy holds promising potential as a novel treatment option for patients with obesity both as a monotherapy and in combination with other anti-obesity drugs. Our preclinical studies have shown significant weight loss with GUBamy alone and additive weight loss in combination with other anti-obesity drugs,” says Mads Axelsen, Chief Medical Officer at Gubra. “I am proud of our dedicated clinical team who has progressed GUBamy to this Phase 1 clinical trial, which marks a very important milestone for Gubra,” he adds.
The Phase 1 study
The phase 1, First-In-Human, randomized, single ascending dose trial, will assess safety, tolerability, pharmacokinetics, and pharmacodynamics of GUBamy administered in lean to overweight but otherwise healthy subjects. The study will be conducted in up to 48 subjects divided in 6 cohorts at Quotient Sciences in Nottingham in the UK. The first cohort of subjects will be administered with a single dose of 0.5 mg GUBamy. After each dose cohort, a safety review will be performed and a decision about study progress and dose will be made for the next dose cohort. In addition to assessing the safety (primary objective), the trial will also evaluate the pharmacokinetic properties of GUBamy as well as the pharmacodynamic effects on gastric emptying and metabolic and hormonal changes. The trial is expected to complete enrollment mid-2024. Additional information about the Phase 1 trial is available via ClinicalTrials.gov (NCT06144684).
GUBamy (GUB014295) is a long-acting amylin agonist for once weekly subcutaneous (s.c.) administration. GUBamy is in development for weight management in people living with obesity. The drug product is a sterile solution with a neutral pH. The physical and chemical properties of GUBamy solution is compatible with future co-formulation with other anti-obesity injectable drugs (e.g. GLP-1 agonists, dual and triple agonists etc.).
Additional information about GUBamy can be found in the enclosed presentation material.