Veru Inc. entered into a clinical supply agreement (the Supply Agreement) with Novo Nordisk A/S in conjunction with the Company's Phase 2b PLATEAU clinical study. The objective of the Phase 2b PLATEAU clinical study is to evaluate the combination of enobosarm, the Company's oral, first-in-class, novel small molecule, selective androgen receptor modulator, with Novo Nordisk's Wegovy (semaglutide for injection), a GLP-1 RA, in older adults with obesity who are receiving Wegovy therapy for weight reduction. Under the terms of the Supply Agreement, the Company is solely responsible for conducting and sponsoring the Phase 2b PLATEAU clinical study while Novo Nordisk will supply Wegovy to the Company at no charge and as required for the conduct of the Phase 2b PLATEAU study.
Novo Nordisk provides Wegovy solely for use within the study under a clinical supply agreement. In return, the Company will provide Novo Nordisk with insights into obesity and weight management trial design, methodology, and clinical conduct, including regular clinical study updates, protocol changes, and safety updates. While the Company maintains full global development and commercialization rights to enobosarm, the Company has granted Novo Nordisk a right of first negotiation in the Supply Agreement if the Company in the future intends to develop, commercialize, or license enobosarm intellectual property in combination with any Novo Nordisk GLP-1 product, including Wegovy, for any indication.
Novo Nordisk's participation in the PLATEAU study does not constitute endorsement of enobosarm or the combination approach tested in the study and Novo Nordisk's supply of Wegovy (semaglutide) for the study does not constitute any representation regarding semaglutide's requirement for adjunctive therapy. Wegovy is a registered trademark of Novo Nordisk A/S.
