pegapamodutide (OPK88003) / OPKO Health, LeaderMed - LARVOL DELTA

OPKO Health and Entera Bio Enter into Collaboration Agreement to Advance Oral GLP-1/Glucagon Tablet Candidate into the Clinic to Treat Obesity and Metabolic Disorders (GlobeNewswire) - "OPKO Health, Inc...and Entera Bio Ltd...entered into a collaboration and license agreement to advance into the clinic the first oral dual agonist GLP-1/glucagon peptide as a once-daily tablet treatment for patients with obesity, metabolic and fibrotic disorders. The program combines OPKO’s proprietary long-acting oxyntomodulin analog (OPK-88006) and Entera’s proprietary N-Tab technology...The companies expect to file an Investigational New Drug application with the U.S. Food and Drug Administration (FDA) later this year....Under the terms of the agreement, OPKO and Entera will hold 60% and 40% pro-rata ownership interests, respectively, in the program and be responsible for 60% and 40% of the program’s development costs, respectively."

IND • Licensing / partnership • Metabolic Disorders • Obesity

LeaderMed Group and OPKO Health Form Joint Venture to Develop and Commercialize Oxyntomodulin and Factor VIIa-CTP in China and Other Asian Territories (GlobeNewswire) - "LeaderMed Health Group Limited...and OPKO Health, Inc...announce the formation of a joint venture to develop...two of OPKO’s clinical stage, long-acting drug products in Greater China and eight other Asian territories. Under the terms of the agreements, OPKO will grant the joint venture exclusive rights to develop, manufacture and commercialize (a) OPK88003...and (b) Factor VIIa-CTP...in exchange for a 47% ownership interest in the joint venture. In addition, OPKO will receive an upfront payment of $1 million and will be reimbursed for clinical trial material and technical support it provides the joint venture. LeaderMed will be responsible for funding the joint venture’s operations, development and commercialization efforts and will, with its syndicate partners, initially invest $11 million in exchange for a 53% ownership interest. OPKO retains full rights to oxyntomodulin and Factor VIIa-CTP in all other geographies."

Licensing / partnership • Genetic Disorders • Hemophilia

Emerging glucagon-like peptide 1 receptor agonists for the treatment of obesity. (PubMed, Expert Opin Emerg Drugs) - "There is a strong interest in developing obesity treatments based on glucagon-like peptide-1 (GLP-1) agonism, which have proved to limit morbidity and mortality in type 2 diabetes.Areas covered: This review provides an overview of current compounds containing GLP-1 receptor agonism in clinical development for obesity, with mono-activity at the GLP-1 receptor (PF-0688296, glutazumab, semaglutide) or engaging one or more other endogenous hormonal systems involved in energy balance and metabolism, including glucagon, oxyntomodulin, glucose-dependent inhibitory peptide and amylin (CT-868, CT-388, AMG 133, tirzepatide, NNC9204-1177, JNJ-54728518, SAR425899, pegapamodutide, MK8521, cotadutide, efinopegdutide, BI-456906, cagrilintide + semaglutide 2,4 mg, HM15211, NNC9204-1706).Expert opinion: Many novel compounds employing GLP-1 receptor agonism are in clinical development. Semaglutide is farthest in clinical development and will presumably become a benchmark for this class of..."

Journal • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

A Study to Compare a New Drug for Type 2 Diabetes to Placebo and to a Treatment Already Available for Type 2 Diabetes (clinicaltrials.gov) - P2; N=420; Completed; Sponsor: Eli Lilly and Company; Active, not recruiting ➔ Completed

Trial completion • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus • FGF21