A tweet from Danielle Belardo, MD

Cardiology Pharmaceuticals

Merck’s $11B Acceleron Merger is Paying Off

Merck just announced that its pulmonary arterial hypertension (PAH) drug candidate sotatercept delivered positive results in a pivotal Phase 3 clinical trial, potentially paving the way for a multibillion-dollar therapeutic and new hope for PAH patients.

Merck bought Acceleron last year for $11B in order to gain access to sotatercept, hoping to bulk up its portfolio before its blockbuster cancer drug Keytruda goes off patent in 2028. The company wagered that sotatercept had the potential to make it to market and buffer revenue losses in the face of generic competition. So far, the bet appears to be paying off. 

PAH Patients in Merck’s STELLAR trial demonstrated a “statistically significant and clinically meaningful” improvement in 6-minute walk distance from baseline at 24 weeks when added to background therapy (the primary endpoint). Eight of nine secondary endpoints were also met. The company plans to present detailed results at an upcoming conference. 

The Takeaway 
A new add-on treatment for pulmonary arterial hypertension may be on the horizon. The STELLAR data validates the Acceleron acquisition and bolsters Merck’s portfolio of cardiovascular drugs ahead of its upcoming patent cliff, and a promising new PAH drug may be on the way. 

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The Wire

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• Why Air Pollution Causes Heart Attacks: Harvard researchers discovered that particle radioactivity may fuel the toxicity of air pollution and explain why pollution increases heart attack incidents. Based on exposure predictions plus data from over 700k deaths, the authors determined that exposure to particle radioactivity alone was tied to a 16% increased risk of heart attack death. Exposure to the fine particulate matter in air pollution alone still increased the risk of heart attack death, but to a lesser extent (16% vs. 6%). Risk of stroke death was elevated by 11% in both arms. 

• Lilly’s Obesity Drug Gets Fast Tracked: Eli Lilly gained FDA Fast Track designation for its drug tirzepatide for the treatment of obesity. Earlier this year, Lilly locked-in tirzepatide’s FDA approval for type 2 diabetes and shortly thereafter released a study showing that tirzepatide helped adults with obesity lose over 20% of their weight. The new designation lays the groundwork for an expedited New Drug Application review process, which will primarily be based on data from SURMOUNT-1, which is already complete, and SURMOUNT-2, which should wrap up in mid-2023. 

• scPharmaceuticals’ Furoscix Crosses FDA Finish Line: After two unsuccessful attempts, scPharmaceuticals has gained FDA approval for its infusor Furoscix to treat fluid overload in congestive heart failure patients. Similar to IV diuretics, the self-administered device relieves fluid retention and swelling through an 80mg injection of generic furosemide delivered over five hours. 

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• AliveCor Diagnostic Cardiology Impact: A deep dive from Signify Research highlighted AliveCor’s recent moves to integrate its KardiaMobile personal ECG system with other vendors including GE, Biotronik, Dignio, and Omron. Signify noted that through partnerships like these, AliveCor may be uniquely positioned to offer solutions across the cardiology care continuum and that AliveCor is “one to watch” in the diagnostic cardiology market. 

• Big Tobacco Targets Youth, Women, Black Communities: A Stanford study fortifies existing evidence that shows Big Tobacco ads and internal documents from the 1930s through today intentionally target youth, women, and Black communities. The report comes as the FDA weighs public comments on draft rules to remove menthol cigarettes and flavored cigars from the market. 

• Heart Failure Research Initiative: The FNIH and the NHLBI are launching a partnership to develop new treatment strategies for HFpEF. The Accelerating Medicines Partnership Heart Failure (AMP HF) Program will utilize two complementary approaches to develop a framework for new precision treatments: (1) analyzing existing HFpEF datasets, and (2) initiating a new clinical trial to confirm retrospective findings in an observational cohort. AMP HF brings together funding from eight organizations spanning the private and public sectors, including Ultromics, Cytokinetics, and the American Society of Echocardiography.

• Eating Earlier Boosts Health: Two studies in Cell Metabolism show that eating earlier in the day may help with weight loss, and eating meals within a 10-hour window could improve blood sugar and cholesterol levels. In one study, researchers found that eating later in the day made people hungrier during a 24-hour period, and also burned calories at a slower rate and led to fat tissue that stored more calories (N=16). The second study found that eating within a 10-hour window improved blood pressure and blood sugar and decreased the size of bad cholesterol particles (N=137).

• Vektor’s Heart Mapping Validation: New data continues to validate Vektor Medical’s arrhythmia mapping technology vMap. Designed to reduce procedure time and increase ablation success, the FDA-cleared system uses 12-lead ECG data to locate cardiac “hot spots” and find the root cause of arrhythmia. The non-invasive system was tied to reduced procedure time (227 vs. 295 minutes), fluoroscopy time (18.4 vs. 34.7 minutes), as well as lower EP lab costs. 

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