The trial of base editing lowers cholesterol, but it raises safety concerns
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The first humans trial of cholesterol control with VERVE-101: Implications for the PCSK9 level and the safety of base editing
The first humans trial of base editing has positive results for keeping cholesterol levels in check.
Before receiving VERVE-101, the study participants had an average LDL level of 193 mg/dL. After 28 days, participants treated with either a high or low dose of VERVE-101 had their PCSK9 levels reduced by up to 84%. Their cholesterol levels dropped by more than 50%.
The findings have been criticized. Two serious adverse events in the trial, including a death, have raised safety concerns, and Verve’s share price plummeted by nearly 40% following the results’ release despite their promise.
The interim results from a Phase 1b trial were reported by Verve at a meeting of the American Heart Association in Philadelphia. The trial will continue next year after receiving approval from the US Food and Drug Administration.
The side effects of the treatment were brief, such as flu-like symptoms, headaches and body aches, as well as an increase in liver enzymes, which returned to normal within days.
Time Will Tell Whether Non-Rare Editing is Viable? A Press Briefing on Verve Genetics and Biomolecular Medicine
When there are viable alternatives, editing sentiment is going to be a challenge. Michael said in the post that time will tell if non- rare is viable.
According to a geneticist at a University in Milan, Italy, there is still more work that needs to be done in regards to the technology. “The delivery by nanoparticles is still in early stages in terms of tolerability.”
There is a risk of off target edits elsewhere in the genome. In animal studies, the Verve team found no off-target editing in mice, and no evidence of the changes in the PSCK9 gene becoming heritable in monkeys. Verve’s aim is to select the best dose for the trial and to launch a phase 2 trial in the near future.
The FDA has mandated that the firm follow trial participants for 14 years. You are changing the genome forever with this study. Safety is going to be of the utmost importance, especially because there are currently safe and efficacious strategies available for lipid lowering,” said Watson at the press briefing.
The first patient was treated just six months ago, and researchers are still following all of the participants. The preliminary results were presented at the American Heart Association’s annual meeting in Philadelphia on November 12.
A mid-stage trial of base editing drug VERVE-101 was reported at a meeting of the American Heart Association. Results showed that after 28 days, participants who received a high or low dose of VERVE-101 had their PCSK9 levels reduced by up to 84%. They also saw their cholesterol levels drop by over 50%. The trial will continue next year.
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