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The Food and Drug Administration has a bevy of safety concerns surrounding Verve Therapeutics‘ (VERV) gene-editing approach to high cholesterol, leading VERV stock to crash Monday.
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Last month, the FDA placed Verve’s application to begin human testing in the U.S. on hold. Over the weekend, Verve filed a document with the Securities and Exchange Commission explaining why. Part of the FDA’s concerns boil down to safety — worries of genetic edits becoming inheritable and unintended effects of changing the gene responsible for high LDL cholesterol.
In addition, the FDA asked for additional data from ongoing human studies in New Zealand and the U.K.
VERV stock crashed 10.8% to 21.42 on today’s stock market. Shares of other gene-editing stocks also tumbled. Crispr Therapeutics (CRSP) lost 4.4% and closed at 52.11. Intellia Therapeutics (NTLA) stock skidded 8.9% to 42.01. Editas Medicine (EDIT) dropped 4.1% to 9.83. Beam Therapeutics (BEAM) fell 5.2% to 44.37.
VERV Stock: Turning Off A Gene
Verve’s approach to high cholesterol sounds simple on its face.
The company hopes to use gene editing to turn off the PCSK9 gene. The gene is responsible for regulating proteins involved in blood cholesterol levels. In some people, these proteins lead to high LDL cholesterol. High cholesterol carries of a host of potential complications, including heart attack, stroke and death.
Though Verve is already testing its drug in people in New Zealand and the U.K., U.S. regulators appear more hesitant.
Verve has tested the gene-editing drug in monkeys. Now, the FDA wants additional information as to whether the drug could be more potent in people. The agency is also concerned about the risk of germline editing. Germline editing involves changing DNA in a way those changes could be passed onto children. It has been widely rejected by the scientific community.
It’s important to note, there are non-gene editing approaches to high cholesterol. The first treatment is generally statins, which have been on the market for a long time. There are also drugs that inhibit the PCSK9 proteins. Further, Alnylam Pharmaceuticals (ALNY) sells a drug that temporarily silences the same PCSK9 gene.
Questions Surrounding Side Effects
U.S. regulators also asked Verve to provide additional data regarding the potential risk of unintended and unexpected side effects outside the liver. The actual genetic change, in this case, takes place in the liver.
These requests prodded VERV stock to hit its lowest point since July.
Further, the FDA asked Verve to provide it with additional data from ongoing human tests abroad. The agency also wants Verve to run human testing differently in the U.S. It will require more restrictive contraceptive measures in participants and a longer period of time between doses.
“Verve intends to submit a response as expeditiously as possible,” the company said in its filing.
The company expects initial data from the Phase 1 study in New Zealand and the U.K. in the second half of 2023.
Follow Allison Gatlin on Twitter at @IBD_AGatlin.
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