Novo Nordisk trial, Verve basic editing, etc.

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There’s a lot of cardiovascular news this morning: we discuss Novo Nordisk’s plans for heart disease, and Verve’s gene-editing therapy for familial hypercholesterolemia. We also learned about a new initiative to try to prevent the spread of gonorrhea with a meningitis vaccine.

What you need to know this morning
• Forge Biologics, a privately held contract manufacturer of cell and gene therapies, was acquired by Japanese multinational food and biotechnology group Ajinomoto for $554 million. Forge was founded in 2020 and is backed by Perceptive Advisors’ Xontogeny Venture Fund.
• Aclaris Therapeutics said the experimental drug failed to reduce symptoms compared with placebo in a mid-stage clinical trial in patients with rheumatoid arthritis. The company is halting development of the drug, zunsemetinib, including ongoing studies in psoriasis.
• Vir Biotechnology presents new data from mid-stage studies involving experimental treatments for chronic hepatitis D and hepatitis B.

Novo Nordisk wants to become a better cardiovascular player
Novo Nordisk’s main focus has been the diabetes and obesity markets, but now it aims to become a major player in heart disease. The company said in August that its drug Wegovy reduced the risk of heart attack, stroke or death by 20% in a pivotal trial, sending its shares soaring. The company presented the full details of the study to an audience at the American Heart Association meeting last weekend: The drug could reduce heart attack rates by 28%, stroke rates by 7% and cardiovascular-related deaths by 15%. %.

“This is the first weight management therapy we have shown in a rigorous trial to reduce the excess risk of cardiovascular events associated with overweight and obesity,” the study’s lead researcher told STAT. “This now establishes overweight and obesity as a new pathway and another modifiable risk factor that we can treat in patients with cardiovascular disease.”

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Verve’s base editing treatment lowers LDL cholesterol
Verve Therapeutics’ CRISPR-based gene-editing treatment successfully reduced “bad” cholesterol levels in patients with inherited high cholesterol in a small trial.

Ten patients in the phase 1 trial had heterozygous familial hypercholesterolemia, an inherited disorder that causes high levels of bad cholesterol and advanced heart disease. Nine people had already undergone heart surgery, four had a history of heart attacks, and all were unable to control their condition with approved medications.

When the base-editing therapy was given to three patients, LDL-C levels were reduced by 39%, 48%, and 55%, respectively. The drop in the latter’s high cholesterol lasted for six months. The results were presented last weekend at an American Heart Association meeting.

“It’s early days, but we think these data open the door to a completely new approach to treating coronary heart disease — a one-time therapy that can sustainably lower LDL,” Verve CEO Sek Kathiresan told STAT.

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A conversation with Eli Lilly’s Chief Strategy Officer (CSO)
Eli Lilly also has its own interest in the above research: it has its own GLP-1 drug Zepbound for treating obesity, which was approved by the FDA just last week. The company is also working with Verve Therapeutics to develop gene-editing drugs. The company’s CSO Dan Skovronsky spoke with STAT and shared some of his thoughts on its path forward in the cardiovascular space.

“When I think about the pharmaceutical industry and the 10 companies that spend $50 billion to $100 billion a year on R&D, that’s the largest investment 10 to 20 years from now in improving human health,” Skovronsky told STAT. “We can make more and more powerful drugs, and sometimes that’s necessary … but sometimes we can look at areas like cardiovascular disease and say the biggest problem isn’t that the drugs aren’t good enough, but that people stop taking them.”

He believes the solution to patients’ lack of compliance with more standard medications is through science and technology.

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UK expert group recommends meningitis vaccine to prevent gonorrhea
A British immunization expert panel has recommended that people at high risk of contracting gonorrhea could use the meningitis B vaccine to reduce the incidence of sexually transmitted infections.

“The introduction of the MenB vaccination program to prevent gonorrhea in the UK would be a world first and should significantly help reduce gonorrhea levels, which are currently at record highs,” the group’s chair said in a statement.

Neisseria gonorrhoeae, the bacterium that causes the infection, is becoming increasingly resistant to antibiotics. GSK’s vaccine Bexsero protects against meningitis B, one of the serotypes of the Neisseria meningitidis bacteria. The genetic sequence similarity between the two bacteria is between 80% and 90%. The similarity suggests the vaccine may provide at least some protection against gonorrhea.

read more.

More reading
• The UK has just approved a drug to prevent breast cancer. American women may not know it’s already an option, STAT
• Boston-area lab space vacancy rate climbs to 10-year high, The Boston Globe reports
• Anthos stroke drug appears safer than common blood thinners in mid-stage trial, STAT

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