Gubra A/S has announced the submission in Germany of a clinical trial application (CTA) for a first-in-human study of GUB-UCN2, the company’s lead asset for weight loss. The planned phase I/IIa trial will enroll both healthy volunteers and individuals with obesity, with and without related co-morbidities. GUB-UCN2 is expected to enter clinical development in the first half of this year.
Abbvie Inc. is buying into the obesity fray in a potential $1.875 billion development and commercialization agreement with Danish peptide drug discovery specialist Gubra A/S. In addition, there will be a $350 million up-front payment as Abbvie takes over the reins of GUB-014295 (referred to as Gubamy), a long-acting analog of the satiety hormone amylin, currently in phase I development.
Fatty acid synthase (FASN), an enzyme that drives de novo lipogenesis, plays a relevant role in metabolic disorders such as obesity, non-alcoholic fatty liver disease (NAFLD) or type 2 diabetes. Denifanstat (TVB-2640), a FASN inhibitor, has recently shown positive results in a phase II study in patients with metabolic dysfunction-associated steatohepatitis (MASH).
