Verve Therapeutics Inc. shares
VERV,
fell 40% premarket on Monday after the biotech company on Sunday released early-stage clinical trial data on its experimental gene-editing treatment for high cholesterol.
The treatment, VERVE-101, reduced low-density lipoprotein cholesterol in people with heterozygous familial hypercholesterolemia, an inherited genetic condition that can cause dangerously high cholesterol, the company said in a release. VERVE-101 is a single-course treatment designed to durably lower LDL cholesterol by inactivating the PCSK9 gene in the liver.
Some analysts, however, said Verve’s data did not yet clearly differentiate the efficacy of its experimental treatment from that of Novartis AG’s
NVS,
Leqvio, which recently got U.S. regulatory approval for an expanded label for earlier treatment of LDL cholesterol.
The Verve results “failed to beat elevated expectations” heading into the data release, Leerink Partners analysts wrote in a note Monday.
Analysts also raised concerns about some patients in the clinical trial showing elevated liver enzymes, a potential sign of liver damage. The elevation is “transient, it’s asymptomatic, there’s no long-term injury to the liver,” Verve’s chief scientific officer Andrew Bellinger said on a call with analysts Sunday.
Very few patients with the inherited condition have met their LDL cholesterol goal, in part because the current treatment method requires lifetime therapies, Dr. Deepak Bhatt, director of the Mount Sinai Fuster Heart Hospital, said in a statement. “I am very encouraged by the initial data” from the trial, which show that VERVE-101 could meaningfully lower LDL-C in these patients, Bhatt said.
The trial results come about two weeks after Eli Lilly & Co.
LLY,
purchased certain Verve gene-editing product rights, including VERVE-101, from Beam Therapeutics
BEAM,
Verve shares are down 18.9% in the year to date, while the S&P 500
SPX
has gained 15%.
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