Ocedurenone

Photys Therapeutics is on deck to tackle preclinical efforts, while Novo Nordisk is slated to take the potential assets through IND-enabling studies and clinical development. \n With Novo Nordisk’s name already synonymous with treatments for diabetes and obesity, the Danish drugmaker has been making a concerted push to bolster its pipeline beyond GLP-1 stalwarts Ozempic and Wegovy, branching out into other cardiometabolic conditions like metabolic dysfunction-associated steatohepatitis (MASH) and chronic kidney disease (CKD).Now, as part of that development odyssey, the company is tapping into an emerging protein technology from Photys Therapeutics.Under a new research collaboration unveiled Wednesday, Novo will pay Photys up to $186 million in upfront, development and commercial milestone payments to help develop proximity-based therapeutics for an unnamed cardiometabolic disease target.The deal—which will also see Photys receive R&D funding and potential tiered royalties on commercial sales—hinges on the biotech’s Phosphorylation Inducing Chimeric Small molecules (PHICS) technology. The company has designed its proprietary platform to induce proximity between a kinase and a protein of interest in order to phosphorylate that target and change its biologic function, Photys explained in a release.Novo and Photys plan to work together on multiple PHICS molecules for their chosen cardiometabolic target. Photys is on deck to tackle preclinical efforts, while Novo is slated to take the potential assets through investigational new drug-enabling studies and clinical development, the partners said.“This collaboration represents a strong alignment between the desire to control a critical protein and a technology capable of doing so in a tissue-specific manner,” Alexandra Joseph, Ph.D., Photys’ chief scientific officer, said in a statement.Meanwhile, Novo’s corporate vice president and therapeutic area head of diabetes, obesity and MASH, Bei Zhang, Ph.D., said the deal could allow her company to reach important protein targets “with a high degree of efficacy and selectivity.” Photys, which is based right next to Boston in Waltham, Massachusetts, uncloaked in 2022 with $75 million in funds from Merck & Co.’s MRL Ventures Fund, Eli Lilly, Arkin Bio and Mass General Brigham Ventures, among others.The biotech has stayed relatively quiet over the last two years, with the October appointment of Joseph the most recent update on the company’s website.Novo Nordisk, for its part, has been working hard to enrich its cardiometabolic pipeline in areas beyond diabetes and obesity, where the company currently dominates the commercial market with its respective GLP-1 medicines Ozempic and Wegovy.So far, the company’s success has been somewhat mixed.Back in May, Novo unveiled full results from its FLOW trial showing that a once-weekly 1-mg dose of semaglutide—the molecule behind Ozempic and Wegovy—helped combat major kidney outcomes like kidney failure, loss of kidney function and death from kidney or cardiovascular causes in people with Type 2 diabetes and CKD.At the time, Novo’s executive medical director, Michael Radin, M.D., told Fierce Pharma the results could “really move the needle” and set a new standard for “holistic” care for many patients living with both diabetes and kidney disease.Additionally, 2.4-mg semaglutide recently excelled in a phase 3 study of MASH patients, prompting Novo to ready filings for submission to regulators in Europe and the U.S. in the first half of 2025. Still, Novo has been less fortunate with external cardiometabolic efforts, as evidenced by the drugmaker’s decision in early November to scrap a late-stage kidney drug acquired through a $1.3 billion deal with KBP Biosciences.Novo had hoped the CKD prospect, dubbed ocedurenone, could eventually rival Bayer’s Kerendia. But those hopes were dashed when the nonsteroidal mineralocorticoid receptor antagonist missed its primary endpoint at the time of a prespecified interim analysis. With ocedurenone gone, the only CKD program still listed in Novo’s pipeline is semaglutide. 

Novo Nordisk disclosed several key updates from its cardiometabolic and hematology pipelines Wednesday as the drugmaker revealed its third-quarter profits edged out expectations. First up, the Danish pharma giant said semaglutide met the primary endpoint of a Phase 3b trial in people with peripheral arterial disease (PAD) and type 2 diabetes. At 52 weeks, 13% of people given semaglutide saw a “statistically significant” improvement in their maximum walking distance compared with placebo, according to a Wednesday release . Novo said it plans to file for approval of Ozempic in PAD in the first half of next year. Also in the diabetes space, the company’s DNA immunotherapy candidate has a safe and well-tolerated profile based on a Phase 1 test in August. The treatment is designed to preserve the body’s natural production of insulin and thus slow down or stop type 1 diabetes in people at high risk of developing it. The company has yet to spell out what it plans to do with the asset. On the hematology side, the Danish drugmaker said it is gearing up to file for approval for its hemophilia A prophylactic therapy next year. The treatment, dubbed Mim8, led to better annualized bleeding rates in a Phase 3b trial comparing it with standard-of-care emicizumab. Novo also said it terminated overall development of its mineralocorticoid receptor antagonist, named ocedurenone, after stopping a Phase 3 trial in chronic kidney disease earlier this year. The trial came to an end in June after it was deemed unable to meet its endpoints. Elsewhere, the Danish drugmaker’s Q3 performance appears to be better than Eli Lilly’s, with net profits coming in just ahead of the Wall Street consensus of DKK 27 billion ($3.9 billion). By contrast, Lilly’s total Q3 revenues of $11.4 billion missed its $12.2 billion consensus forecast. Novo’s shares $NVO rallied as much as 4% premarket Wednesday. The drugmaker narrowed its expectations for 2024 sales growth to between 23% and 27% from an original range of 22% to 28%. The revision comes after the company trimmed its guidance for profit growth in the second quarter. Both Novo and Lilly are facing competitive pressures from companies making compounded versions of their blockbuster diabetes and weight loss drugs. But Novo, during its earnings call with the media, underscored safety issues with these compounded drugs. “We have been looking at a number of compounded products in the market and identified multiple safety concerns and also noted more than 100 hospitalizations and 10 deaths based on compounded semaglutides,” CFO Karsten Munk Knudsen said. Last month, a trade group of compounding pharmacies sued the FDA for taking Eli Lilly’s tirzepatide off its shortage list despite some evidence that the drug was still in short supply.