Carmot Therapeutics, Inc.

Antitrust regulators shouldn’t clear Novo Holdings’ planned acquisition of Catalent, Roche CEO Thomas Schinecker said Wednesday, adding to the pressure that industry competitors appear to be trying to generate against the takeover. The deal would boost Novo Nordisk’s manufacturing capacity as it tries to meet huge demand for its obesity drugs. But Roche — which is developing its own obesity drugs — and Novo’s main rival Eli Lilly have now opposed it. While Roche was quick to highlight that it wouldn’t be directly affected by the Novo-Catalent deal, Schinecker said “it would be a wrong decision” for authorities to allow a transaction that could limit competition from a broader industry perspective. “It could be a problem for other smaller players if there is a restriction in how many [manufacturers] are available,” Schinecker said during a call with reporters on Wednesday. Lilly has made similar comments, raising concerns that a competitor would own a major supplier relied on by much of the industry. In February, Novo Holdings announced the $16.5 billion plan to buy Catalent, with Novo Nordisk set to buy three sites from Novo Holdings for $11 billion. A few weeks later, Eli Lilly CEO David Ricks said the deal was “unusual” and called for a broad inquiry into the transaction. And in August, he said Lilly had been using Catalent for manufacturing of its GLP-1 drug. Other pharma companies and smaller biotechs developing obesity drugs largely declined to comment when reached by Endpoints News on Wednesday. In the US, the Federal Trade Commission continues to review the deal, and people familiar with the situation say they’re not yet near a decision about whether to block it or ask for some sort of concession. Consumer and union groups called on the FTC to challenge the takeover, alleging it will impact competition for weight loss drugs and cell and gene therapies. Sen. Elizabeth Warren (D-MA) urged the FTC to thoroughly scrutinize the deal and its compliance with antitrust laws. Over the course of the year, Novo and Catalent have reiterated that, despite several delays , the deal is still scheduled to be completed by year’s end. And on Monday, Catalent penned an open letter to customers reassuring them that it would operate as a fully independent CDMO after deal completion. On Wednesday’s call, Roche pharma chief Teresa Graham underscored that “Roche has one of the largest and most diverse manufacturing footprints in the industry,” and so “we are not at all concerned that we will need additional CMO capacity,” she added. The company has several next-generation weight loss assets in the clinic that it obtained as part of its acquisition of Carmot Therapeutics .

A venture capital firm that seeks to digitize the life sciences ecosystem has plans for a $500 million follow-up fund, according to a Tuesday SEC filing. The firm, Dimension Capital, debuted in January 2023 with a $350 million inaugural fund , and invests in startups from young entrepreneurs, academics and engineers, according to its website. Representatives for the investor didn’t immediately respond to questions about the new $500 million fund. Dimension’s portfolio includes startups like plant chemistry-inspired Enveda Biosciences , AI foundation model-based Chai Discovery and others, including the next bet from the founder of obesity biotech Carmot Therapeutics . There have been signs that young venture firms have struggled to raise new money for second funds. Across the VC ecosystem, about 37% of first-time VCs cannot raise a second fund, according to a PitchBook report from February. Dimension’s leaders have a track record behind them, however. It was founded by ex-Lux investors Adam Goulburn and Zavain Dar , as well as former Obvious venture partner Nan Li. “I suspect most will look at our strategy today as niche (and frankly I want them to continue to do so for as long as possible),” Dar said in a Slack interview with Endpoints News in February. “In 10 years, though, this will be the primary strategy for value creation and capture in the ecosystem.” At the time of its launch, Goulburn told Endpoints that Dimension aimed to be a “lighthouse firm for the digitization of the life sciences industry.” The firm said then it sees biologists, chemists and computer scientists coming together to lead the next generation of companies in the life sciences field. “That siloing is just so outdated,” Li said in January 2023, noting Dimension wanted to be a “one-stop shop” for nascent entrepreneurs. Dimension was among a crop of new life science investment firms to emerge in early 2023, including Curie.Bio (which disclosed another fund in June ), NYBC Ventures and Cure Ventures. If successful, Dimension’s proposed raise would add to a growing list of life sciences investors who have recently laid out additional funds, including at Flagship, Bain, ARCH and Forbion. Some smaller firms are also pulling in capital, including KdT Ventures, Asabys Partners and others.

Within the pharmaceutical industry, a multibillion-dollar race is underway to top Novo Nordisks and Eli Lillys in-demand obesity drugs.Dozens of companies, large and small, have set out to test experimental medicines they claim could be more potent, convenient or have fewer side effects than Novos Wegovy and Lillys Zepbound. But those two companies are already hard at work with successors of their own.The next six months figure to be an important preview. Data are expected for a number of drugs that are already, or are shaping up to be, contenders in this high-stakes competition. The readouts will be closely watched, as they will set expectations for how the obesity drug market currently a duopoly between Lilly and Novo will look in the future. Heres what to expect:Zepbound versus WegovyHead-to-head trials always carry high risk. Any company that sponsors one is doing so with the knowledge testing could reveal its drug is equivalent to a competitor or, worse, less effective.With Zepbound, Eli Lilly appears to believe its a risk worth taking. In a trial called SURMOUNT-5, Lilly enrolled 700 people in an attempt to prove Zepbound is better than Wegovy at reducing the body mass of people with obesity or who are overweight, and have another weight-related complication like heart disease or high blood pressure.It expects to have results by the end of the year, and the findings could impact physician and patient perception of which drug offers greater weight loss benefits..So far, Zepbound has seemed superior, as testing showed treatment helped people with obesity lose up to 21% of their body weight. The comparative figure for Wegovy was 16% in the Phase 3 trials Novo used to gain Food and Drug Administration approval. Based on this, Leerink Partners analyst David Risinger expects Zepbound to show a statistically significant advantage in the head-to-head trial.A resoundingly positive outcome could help push Lilly past $1 trillion in market valuation, a milestone that would be a first among pharmaceutical firms. Lilly is currently worth nearly $900 billion.Yet Lilly has yet to prove Zepbound can prevent cardiovascular complications in people with obesity or who are overweight and already have heart disease, as Novo has with Wegovy. That study result helped Novo gain limited Medicare coverage for people with existing heart disease. Lilly has an outcomes trial called SURPASS-CVOT underway, but doesnt expect to have data until next year.Novos dual agonistWegovy works by stimulating a metabolic hormone called GLP-1, while Zepbound targets GLP-1 and a second one called GIP. The biology behind the dueling approaches is still being sorted, but Zepbounds dual agonism has set a model for others to follow, including Novo.The Danish company is now in late-stage testing with a dual-acting experimental drug it calls cagrisema. The drug combines semaglutide, the active ingredient in Wegovy, with another compound that mimics a metabolic hormone called amylin.Cagrisemas Phase 3 trial, called REDEFINE1, is due to wrap up and generate data in the fourth quarter. The results could help Novo fight off Lillys commercial challenge should SURMOUNT-5 favor Zepbound over Wegovy.REDEFINE1 tests cagrisema against a placebo and Wegovy, measuring weight loss over 68 weeks in about 3,400 people. Cagrisemas performance against Wegovy should give analysts a sense of how well it might also measure up against Zepbound, once the SURMOUNT-5 data are available.Novo is also testing cagrisema directly against Zepbound, but that trial isnt due to generate data for another year.Amgens contenderAmgen isnt known for cardiometabolic drugs, but it has one, called maridebart cafraglutide or maritide, thats among the most closely-watched obesity medicines not owned by either Lilly or Novo.Maritide targets the same two gut hormones, GLP-1 and GIP, that Zepbound does. But, somewhat controversially, it is designed to inhibit rather than stimulate GIP. It is also a monthly shot, compared with the weekly injections used for Wegovy and Zepbound.Phase 2 results for maritide are due by the end of the year. Enthusiasm for the experimental drugs potential has driven Amgens shares higher this year sometimes dramatically so. Phase 1 data Amgen disclosed in February suggested it might drive the most weight loss among tested drugs over 12 weeks, according to Stifel analysts.The Phase 2 trial enrolled nearly 600 people with obesity, some of whom also have diabetes, and randomized them to receive one of several doses of maritide or a placebo. Researchers will measure weight loss over 52 weeks.An obesity pillNovo has advanced an oral version of Wegovy and Lilly has pushed its pill oforgliproninto Phase 3 trials. But there are many rivals staking their competitive future on the idea that people with obesity will prefer a pill over a shot. Roche is one such company, having acquired Carmot Therapeutics for $2.7 billion in late 2023 to gain access to three obesity drugs.A Phase 1 dosing trial of the GLP-1 pill CT-996 is due to wrap up by November, which will give Roche and its investors an idea of the drugs biological activity, safety and weight loss. Roche already reported data from earlier stages of the trial, which tested single and increasing doses in trial volunteers who are overweight or have obesity. The third part will test the pill in 60 people who have diabetes in addition to obesity or being overweight.Roche has already said CT-996 will advance into Phase 2 clinical development based on the Phase 1 data. Its already touting the drugs best-in-class potential, although Phase 2 data will be a better test of that claim. Others are already in Phase 2, including Pfizer with its drug danuglipron and Structure Therapeutics with GSBR-1290. They could soon be joined by Terns Pharmaceuticals TERN-601 and Viking Therapeuticsoral version of VK2735.Preserving muscle massThe rapid weight loss stimulated by GLP-1 agonists melts away muscle as well as fat. That worries some experts, who note how people who discontinue treatment tend to regain weight in the form of fat. Muscle cells also have a higher resting metabolic rate, which results in higher caloric burn.In response, some drugmakers are exploring ways to preserve lean muscle mass. An early test could come in the form of results for Verus enobosarm, a type of drug that stimulates muscle-building hormones. Previously sold under the name Ostarine, it has been tested clinically in people with cancer whose muscles have shrunk, as well as those with muscular dystrophy.In obesity, a Phase 2 test of enobosarm together with Wegovy is underway in people 60 and over who are overweight or have obesity and have lost muscle mass. The trial will measure how much trial volunteers muscle mass changes over 16 weeks, and will compare results in people who receive the two drugs to those who were given only Wegovy. Another endpoint will assess physical function by evaluating how participants climb stairs.Veru expects results by the end of the year. The data could help analysts parse how important lean mass might be in future obesity treatment.A new drug targetOutside of targeting GLP-1, GIP, amylin and other gut hormones, there are a range of other treatment approaches under evaluation. One involves blocking a cannabinoid receptor called CB1 that is known for regulating an appetite-modulating hormone called leptin. CB1 is known to have effects on other biological functions such as inflammation, too.So far, theres been at least one disappointing data point on CB1 inhibition. Phase 2 data for a Novo drug called monlunabant didnt meet expectations for weight loss, leading Novo to state that further work is needed to determine the optimal dosing.The next shot for CB1 may be Skye Biosciences nimacimab, which is due to have interim Phase 2 results by mid-2025. The trial, called CBEYOND, tests nimacimab against placebo, as well as a combination of Wegovy and nimacimab against Wegovy alone. The study will measure weight loss over 26 weeks. Enrolling 120 volunteers, the study should be large enough to detect at least an 8% difference between the experimental drug and placebo, according to the trials plan.Skye shares fell by more than 40% the same day Novo reported its data for monlunabant. '