Achillion Provides Pipeline Update
Conference Call and Webcast to be Hosted Monday, September 30th at 8:30 a.m. EDT
NEW HAVEN, Conn., Sept. 27, 2013 (GLOBE NEWSWIRE) — Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN)
today provided an update on development of compounds in its pipeline of
therapies for the treatment of chronic hepatitis C virus, or HCV.
Achillion today received a response from the U. S. Food and Drug
Administration, or FDA, on the clinical hold related to sovaprevir,
Achillion’s NS3 protease inhibitor. The FDA response indicated that,
while Achillion’s submission addressed all issues noted in the FDA’s
June 29, 2013 letter, the FDA concluded that the removal of the clinical
hold is not warranted.
“While we are disappointed that we were not able to resolve the
clinical hold at this time despite having addressed all the issues, we
believe the breadth of our portfolio allows us to quickly advance other
all oral combination regimens for the treatment of HCV,” stated Milind
Deshpande, President and Chief Executive Officer of Achillion. “With our
Phase 2 NS5A inhibitor, ACH-3102, we are in a position to rapidly
initiate combination studies with ACH-2684, our protease inhibitor, with
results expected in 2014. Further, we continue to advance our
uridine-analog nucleotide, ACH-3422, with which we anticipate initiating
clinical trials in the first half of 2014.”
ACH-2684 has completed all of the necessary preclinical and clinical
trials necessary to support advancement into Phase 2 combination
development. Achillion previously reported robust anti-viral activity
with ACH-2684 as monotherapy including Phase 1b data in both
non-cirrhotic and cirrhotic treatment-naïve HCV genotype (GT) 1
patients. In addition, Achillion will continue to work to resolve the
clinical hold related to sovaprevir.
Phase 2 -007 Trial of Sovaprevir and ACH-3102 with Ribavirin
Achillion also announced interim data from the ongoing -007 Phase 2a
clinical trial evaluating two doses of sovaprevir, either 200 mg or 400
mg once daily, in combination with 50 mg once daily of ACH-3102 and
ribavirin (rbv) twice daily for 12 weeks in patients with
treatment-naïve GT 1a or 1b hepatitis HCV.
The Phase 2 trial is a double-blind, placebo-controlled study
evaluating the safety, tolerability and efficacy of 12 weeks of
sovaprevir, ACH-3102 and rbv in up to 50 treatment-naïve patients with
chronic GT 1a or GT 1b HCV. The first segment enrolled 30 patients who
were randomized to receive a combination of either 200 mg or 400 mg
sovaprevir once daily in combination with a 150 mg loading dose followed
by a 50 mg daily dose of ACH-3102, and twice daily doses of rbv, or
matching placebos. The primary endpoints for this trial include safety,
tolerability, and sustained viral response 4 weeks after the completion
of dosing (SVR4). The trial is being conducted at sites in the United
States, Canada, New Zealand and Australia.
All patients achieved a very rapid virologic response (vRVR) with HCV
RNA less than 25 IU/ml by week 2. Potent efficacy was observed against
GT 1b HCV with 100% of patients achieving rapid viral response, or RVR,
with HCV RNA levels less than 10 IU/mL at week 4. RVR was achieved in
79% of GT1 patients overall.
To date, the combination of sovaprevir and ACH-3102 with rbv for up to
12 weeks has been well tolerated with no drug-related serious adverse
events, no clinically significant changes in vital signs or
electrocardiograms. There have been no graded increases in liver
function tests, including ALT or AST, for patients receiving active
treatment to date. No other laboratory abnormalities were noted with the
exception of decreases in hemoglobin observed and attributed to
The Company will host a conference call and simultaneous webcast on
Monday, September 30, 2013 at 8:30 a.m. Eastern time. To participate in
the conference call, please dial (877) 266-0482 in the U.S. or (631)
291-4567 for international callers. A live audio webcast of the call
will be accessible from the Calendar page in the News Center at www.achillion.com.
Please connect to Achillion’s website several minutes prior to the
start of the broadcast to ensure adequate time for any software download
that may be necessary.
A replay of the webcast will be available on www.achillion.com.
Alternatively, a replay of the conference call will be available
starting at 11:30 a.m. Eastern time on September 30, 2013, through 11:59
p.m. Eastern time on October 6, 2013 by dialing (855) 859-2056 or (404)
537-3406. The replay passcode is 73738655.
About Achillion Pharmaceuticals
Achillion is an innovative pharmaceutical company dedicated to bringing
important new treatments to patients with infectious disease.
Achillion’s discovery, clinical development, and commercial teams have
advanced multiple novel product candidates with proven mechanisms of
action into studies and toward the market. Achillion is focused on
solutions for the most challenging problems in infectious disease
including HCV and resistant bacterial infections. For more information
on Achillion Pharmaceuticals, please visit www.achillion.com or call 1-203-624-7000.