Asundexian

Dive Brief:Regeneron Pharmaceuticals intends to advance two blood-thinning drugs into Phase 3 testing next year after mid-stage study results showed they matched or surpassed marketed medicines at preventing blood clots following knee replacement surgery.Regenerons drugs block a clotting protein, Factor XI, thats been targeted by multiple pharmaceutical companies, some of which have candidates in large, late-stage trials. The data announced Thursday are proof-of-concept results that Regeneron said give it confidence to follow suit.Factor XI blockers have produced mixed results so far in testing, however. Even if approved, they could face commercial challenges, as the effective blood thinner Eliquis is taken orally, rather than via infusion, and generic versions could arrive in 2026.Dive Insight:Regeneron needs its pipeline to deliver.The companys biggest seller, the eye drug Eylea, could face biosimilar competition earlier than expected, complicating its plans to switch patients onto a recently approved, high-dose version thats injected less frequently. Two blood cancer drugs its counting on as future revenue drivers were rejected this year by the Food and Drug Administration, delaying their market arrival and allowing rivals to further establish themselves. Company shares, which peaked in August, have fallen more than 40% since.Positive drug development news, such as with the companys two blood thinners, could help shift investor sentiment.Called REGN7508 and REGN9933, the two drugs bind to different regions of Factor XI, a strategy thats seen as a safer alternative to popular blood thinners like Eliquis. But results from other, similar drugs havent been clear-cut. For instance, Bayer dialed back development of its candidate, asundexian, after it failed a Phase 3 trial last year. Bristol Myers and Johnson & Johnson launched a large, late-stage clinical program for their prospect despite mixed data in earlier testing.In one Phase 2 trial, Regeneron tested a single infusion of REGN9933 against daily use of the anticoagulant enoxaparin or Eliquis given twice daily. In the other, an infusion of REGN7508 was evaluated only against daily enoxaparin. The main goal of both studies was to show Regenerons drugs could prevent vein-blocking blood clots as detected by an X-ray.According to Regeneron, a pooled analysis across both trials showed 7% of those who received REGN7508 later developed a blood clot, versus 17% of those given REGN9933, 21% among those on enoxaparin and 12% of those who took Eliquis.People on REGN7508 had statistically fewer blood clots than people who got enoxaparin, while REGN9933 was judged to be non-inferior, or statistically similar, to enoxaparin, Regeneron said. The company also said REGN7508 was non-inferior to Eliquis. It didnt provide a statistical analysis of REGN9933 versus Eliquis.There were no major or clinically important minor bleeding events in any of the treatment groups, Regeneron said. One patient receiving enoxaparin reported a bruise.Regeneron said the trial showed proof of concept for the two drugs. We are eager to advance REGN7508 and REGN9933 into a broad Phase 3 program beginning in 2025, Regeneron President George Yancopoulos said in a statement.In a Thursday note to clients, RBC analyst Brian Abrahams said the small size of the studies and the lack of bleeding incidents in any patient group made it difficult to tell whether REGN7508 or REGN9933 may be safer than marketed blood thinners.Abrahams also noted how its not clear which indications the company will choose for Phase 3 testing. Any trial in a setting involving people eligible for Eliquis would need to be a head-to-head study, making the risk of failure higher, he wrote. '

Regeneron might be ready for competition with its blockbuster drug Eylea, but it’s not clear that investors are. On Thursday morning, the biotech’s leadership fielded question after question about the strength of the eye drug franchise, asking about upcoming competition from Amgen’s biosimilar and mixed revenue results in the third quarter. The company’s overall sales for its Eylea franchise beat the Wall Street expectations by 2% in the third quarter. But the newer version of the drug, Eylea HD, missed by 8%. The stock $REGN was down about 10% in reaction to the results. Things may not get much better three months from now. Last week, Amgen announced it was preparing to launch an Eylea biosimilar years early after winning a legal case against Regeneron in an appeals court. Regeneron has long dominated the market, with the company delivering “somewhere in the neighborhood” of 100 million Eylea injections, CEO Leonard Schleifer said on Thursday’s earnings call. “They say imitation is the best form of flattery, so we’re glad to be flattered by Amgen that they’re spending their time imitating our products,” Schleifer said on the call. “We’re spending our money trying to bring new products to market, which we think is what this industry really is built for. Biosimilars are fine, but we think the industry is built, and Regeneron is best built, to bring innovative products to market.” Regeneron has never been shy about its lack of interest in developing biosimilars, even as other large biotechs have pursued the market. Schleifer and CSO George Yancopoulos co-founded Regeneron in the late 1980s and remain atop the drugmaker’s board, making them one of the longest-standing scientist-led biotechs in the industry. “We know that there is a biosimilar in the market for Eylea, not Eylea HD. And we know it will be competitive, but we think we’ll be able to compete,” Schleifer said. Regeneron has more than 40 drugs in clinical development, Schleifer emphasized on the call. It did cull one asset in the quarter, however: REGN6569, a GITR monoclonal antibody in Phase 1 for solid tumors, a company spokesperson confirmed to Endpoints News . Meanwhile, Regeneron said it could move two factor XI inhibitors into pivotal trials early next year and plans to report proof-of-concept results before the end of this year. Factor XI drugs aim to take advantage of genetic data showing patients with factor XI deficiency — which in some cases can cause a form of bleeding risk — have reduced incidence of myocardial infarction, stroke and other cardiovascular problems. The factor XI field has had its ups and downs. Bayer stopped a large Phase 3 in atrial fibrillation last year but is still pushing ahead with asundexian in other late-stage testing . Johnson & Johnson and Bristol Myers Squibb’s milvexian is also in late-stage testing, as is Blackstone-backed Anthos Therapeutics . Regeneron’s factor XI work includes an A2 domain-focused asset codenamed REGN9933 and a catalytic domain drug called REGN7508. “Our A2 domain antibody is not a complete blocker of factor XI. It actually is more like a complete factor XII blocker. It’s expected to not have as profound an effect on the coagulation pathways but to have a much milder safety profile,” Yancopoulos said on the call. “In contrast, we believe that our catalytic domain antibody is the best-in-class blocker of factor XI. It will come with the best ability to control coagulation among all agents that are attacking this pathway.” The company also said it anticipates finishing enrollment in its Phase 2 obesity trial, which is focused on preserving muscle mass in patients on Novo Nordisk’s semaglutide. Regeneron plans to have results in the second half of 2025 for the study, which is testing an anti-myostatin called trevogrumab in addition to semaglutide with and without the anti-activin A known as garetosmab. “The simplest regulatory will be just by increasing the actual weight loss and then you’ll be able to show secondary endpoints that you’re doing better on composition of weight loss as well,” Yancopoulos said. “That said, we are going to be measuring metabolic parameters and we’re also going to be measuring functional outputs as well.”