Novo Nordisk A/S has unveiled promising results from its phase 3 REAL8 basket study, showcasing the efficacy and safety of once-weekly Sogroya (somapacitan) in children with various growth disorders. The study, part of the broader REAL clinical trial, compared the long-acting growth hormone to the once-daily Norditropin (somatropin), revealing comparable clinical outcomes and safety profiles after 52 weeks of treatment. This marks a significant step forward in reducing the treatment burden for children and their families.
The REAL8 trial focused on children born small for gestational age (SGA), those with Noonan syndrome (NS), and individuals with idiopathic short stature (ISS). Notably, Sogroya not only matched the efficacy of daily growth hormone treatments but also demonstrated superiority in certain subgroups, including children with NS and those born SGA receiving lower doses of daily growth hormone. These findings highlight the potential of Sogroya to offer a more convenient and equally effective treatment option for pediatric growth disorders.
Adherence to treatment is a critical challenge in managing growth disorders, with the burden of daily injections often leading to decreased compliance. The introduction of a once-weekly treatment like Sogroya could significantly alleviate this issue, improving treatment outcomes and quality of life for affected children. Novo Nordisk's commitment to innovation in this space is evident, as the company seeks to address unmet needs in pediatric endocrinology.
With regulatory submissions for Sogroya in the European Union and the U.S. based on the REAL8 and REAL9 studies, the future looks promising for this novel treatment. As the medical community awaits further developments, the data presented at the joint Congress of ESPE and ESE underscore the potential of Sogroya to transform the treatment landscape for children with growth disorders, offering hope for easier management and better adherence to therapy.
In a landmark deal that underscores the growing importance of metabolic disease treatments, Novo Nordisk has announced a $2.2 billion collaboration with U.S.-based Septerna. This partnership aims to discover, develop, and commercialize oral small-molecule medicines targeting obesity, type 2 diabetes, and other cardiometabolic conditions. The agreement, which includes over $200 million in upfront and near-term milestone payments to Septerna, marks a significant step forward in the quest for innovative treatments in a rapidly expanding market.
The collaboration will initially focus on four development programs aimed at select G-protein-coupled receptor (GPCR) targets, including the GLP-1, GIP, and glucagon receptors. GPCRs play a crucial role in cellular communication and are involved in nearly every organ system of the human body. By leveraging Septerna's proprietary Native Complex Platform™, the companies hope to unlock new therapeutic possibilities for patients worldwide.
Marcus Schindler, Novo Nordisk's Chief Scientific Officer, highlighted the strategic importance of this partnership, noting the company's commitment to broadening its pipeline across various targets and modalities. This deal not only enhances Novo Nordisk's position in the obesity and diabetes markets but also provides Septerna with the resources and operational flexibility to advance its portfolio of GPCR-targeted programs.
As the pharmaceutical industry continues to focus on metabolic diseases, this collaboration between Novo Nordisk and Septerna represents a significant investment in the future of healthcare. With the deal expected to close in the second quarter of 2025, the medical community eagerly anticipates the potential breakthroughs that may emerge from this partnership. The agreement also underscores the increasing value of strategic alliances in accelerating the development of life-saving therapies.