Ibiglustat

Sanofi said Thursday that Dupixent remains on track to record sales of around €13 billion this year after posting strong growth in the first quarter ahead of an expected expansion into chronic obstructive pulmonary disease. Revenue from Dupixent jumped 22.4% in the three-month period to €2.8 billion.The performance of Dupixent, along with Beyfortus (€182 million) and Altuviiio (€122 million), helped the company top expectations, with overall sales rising 2.4% to €10.5 billion, ahead of forecasts of €10.3 billion. However, net income plunged 43.2% to €1.1 billion.Sanofi reiterated its expectation that earnings this year will decrease by a low single-digit percentage at constant currencies. CEO Paul Hudson has braced investors for a period of slower growth over the next few years as the company directs resources into its drug-development, betting on 12 pipeline medicines including amlitelimab, frexalimab and tolebrutinib that it says have blockbuster potential.​​Pipeline setbacksHowever, Sanofi’s ambitions for frexalimab took a hit on Thursday after the company disclosed that development in Sjögren’s syndrome has been halted. Results from a Phase II trial failed to meet the “necessary efficacy outcomes” to continue to work in this indication, the drugmaker said, noting that Phase III studies of the anti-CD40L antibody in relapsing multiple sclerosis and secondary-progressive multiple sclerosis will continue, as well as mid-stage development in type 1 diabetes and systemic lupus erythematosus.Sanofi also disclosed Thursday that the Phase III AMETHIST trial of the GCS inhibitor venglustat for the treatment of GM2 gangliosidosis was discontinued based on “the absence of positive trends” for clinical endpoints. The company also confirmed the discontinuation of the RIPK1 inhibitor oditrasertib -  announced by partner Denali Therapeutics in February – in amyotrophic lateral sclerosis.More to come.

Pictured: Exterior of Sanofi's U.S. headquarters in Bridgewater, N.J./ iStock/JHVEPhoto On Thursday, European drugmakers Sanofi and AstraZeneca announced several pipeline cuts in their respective first-quarter 2024 financial results, including assets to treat Sjögren’s syndrome and cardiovascular disease. According to Sanofi’s first-quarter results, the development of the CD40L antibody frexalimab in Sjögren’s syndrome was halted due to unfavorable Phase II study data. While Sanofi touted the safety and “pharmacologic activity” of the drug, the candidate did not reach the “necessary efficacy outcomes” to move forward. However, frexalimab will continue on in Phase III trials in multiple sclerosis (RMS) and secondary-progressive multiple sclerosis (SPMS) as well as Phase II trials in type 1 diabetes and systemic lupus erythematosus. In February 2024, frexalimab secured positive mid-stage results in RMS demonstrating a slowing in disease activity. The drug is also one of Sanofi’s “pipeline-in-a-product” assets that the company contends can potentially generate annual sales of €5 billion ($5.3 billion). Sanofi is also halting a Phase II study of the molecule venglustat to treat the rare genetic disorder GM2 gangliosidosis. The company said there was an “absence of positive trends” for its clinical endpoints in the trial. The molecule aims to slow disease progress by inhibiting the abnormal accumulation of glycosphingolipids. In 2021, Sanofi stopped a Phase II/III trial of venglustat in kidney disease as it did not reach the futility criteria. In neurology, Sanofi discontinued a Phase II study of the RIPK1 inhibitor oditrasertib in amyotrophic lateral sclerosis (ALS) as the trial failed to reach the primary endpoint of improvement based on the ALS Functional Rating Scale-Revised. Sanofi said it will share the complete safety and efficacy data at an upcoming medical meeting and continue the Phase II study of oditrasertib in MS patients. Sanofi’s pipeline cuts come amid announced layoffs last week as part of the company’s restructuring of its U.S. vaccine operations. Thursday’s Q1 earnings also saw AstraZeneca putting the kibosh on several early-stage medicines, including MEDI6570, designed to block multiple ligands to the LOX-1 receptor. The asset was in a Phase IIb trial, called GOLDILOX, for post-myocardial infarction but was stopped due to a “strategic portfolio prioritization.” Other AstraZeneca assets nixed for portfolio prioritization include the metabolic dysfunction-associated steatohepatitis (MASH) candidate AZD7503. The ligand-conjugated antisense (LICA) drug originally belonged to Ionis Pharmaceuticals and is designed to inhibit the production of hydroxysteroid 17-beta dehydrogenase 13 (HSD17B13). The other asset to get axed is the oral porcupine inhibitor AZD5055, which was in Phase I trials for Idiopathic pulmonary fibrosis (IPF) and other Interstitial lung diseases (ILDs) with progressive fibrosis. The candidate was picked up from Redx Pharma in 2020 for $17 million and $360 million, respectively, in potential milestone payments. For Sanofi’s Q1 results, the pharma reported over €10.4 billion ($11.2 billion) in sales, driven by its blockbuster drug Dupixent which increased 24.9% compared to the same period. AstraZeneca meanwhile pulled in $12.1 billion in sales for the quarter, a 15% boost from Q1 of 2023, with its oncology products bringing in more than $5.1 billion, a 23% bump from the previous quarter. Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.