By Anna Prior
Achillion Pharmaceuticals Inc. (ACHN) said Tuesday the U.S. Food
and Drug Administration has removed the clinical hold on
sovaprevir, the company's experimental hepatitis C treatment.
Shares surged 52% to $6.45 in premarket trading.
The FDA's move allows Achillion to conduct trials in patients
with hepatitis C, the company said, adding that the previously
evaluated dose of sovaprevir that was well-tolerated with clinical
activity in two completed Phase 2 studies may be used in additional
therapeutic clinical trials.
The company is "very pleased that the effort by the Achillion
team, working in collaboration with the FDA, has resulted in this
response for the sovaprevir program," said Achillion executive vice
president and chief medical officer David Apelian.
The company also said it has begun dosing ACH-3422, a
uridine-analog nucleotide polymerase inhibitor, for patients with a
certain type of hepatitis C in an onging Phase 1 clinical
trial.
Achillion said it expects to report proof-of-concept results
from this trial in the fall.
In July, Achillion had said the FDA put sovaprevir on clinical
hold after the company's early-stage study of drug interactions in
healthy patients resulted in elevated liver enzymes tied to
higher-than-expected exposures to sovaprevir and another drug,
atazanavir.
The company had voluntarily stopped dosing in the study after
finding high levels of the liver enzymes in several people enrolled
in the study. Its preliminary investigation found that dosing with
both of the drugs caused a metabolic interaction that substantially
increased the plasma concentration of both drugs.
No serious adverse events were reported at that time.
In September, Achillion said the FDA had decided against lifting
its clinical hold on sovaprevir, news that sent the company's stock
plunging at the time.
The FDA had continued to allow the enrollment of patients in a
separate midstage study evaluating sovaprevir in combination with
other drugs in patients with hepatitis C.
Achillion is competing with Gilead Sciences Inc. (GILD) and
other drug companies to bring an all-oral hepatitis C regimen to
market, hoping to capitalize on what is expected to be a
multibillion-dollar market for the therapy. The treatment from
Gilead called Sovaldi recorded nearly $2.3 billion in first-quarter
sales.
Write to Anna Prior at anna.prior@wsj.com
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