achillion pharmaceuticals (ACHN) Key Developments
Achillion Pharmaceuticals, Inc. Announces Interim Results from Ongoing Phase 2 Proxy Study Evaluating ACH-3102
Aug 15 14
Achillion Pharmaceuticals, Inc. announced interim results from an ongoing Phase 2 proxy study evaluating ACH-3102, Achillion's second-generation NS5A inhibitor, in combination with sofosbuvir, without ribavirin, for eight weeks of treatment in patients with treatment-naive genotype 1 chronic hepatitis C virus (HCV) infection. Of the 12 patients treated, 100% (n=12/12) remained HCV RNA undetectable four weeks after completing therapy (SVR4). Based upon these results, 12 additional patients will begin treatment with six weeks of once daily ACH-3102 and sofosbuvir. Achillion is conducting a Phase 2, open-label, randomized, partial-crossover study to evaluate the efficacy, safety, and tolerability of eight weeks or six weeks of ACH-3102 and sofosbuvir, a marketed nucleotide polymerase inhibitor, without ribavirin, in treatment-naive genotype 1 HCV-infected patients. The primary objective of the study is determination of sustained viral response 12 weeks (SVR12) after the completion of therapy. Eighteen patients were enrolled, including six observational patients. Twelve patients completed eight weeks of treatment consisting of 50 mg of ACH-3102 and 400 mg of sofosbuvir administered once daily while observational patients received no drug during this phase of the trial. Ten of the 12 patients receiving eight weeks of treatment had genotype 1a HCV with median HCV RNA at baseline of 7.22 log(10) (range 5.5 -- 7.8 log(10)). No on-treatment viral breakthrough or post-treatment viral relapse has been observed to date. ACH-3102 and sofosbuvir were well tolerated with no significant adverse events, ECG findings, or lab abnormalities observed during treatment. Following achievement of the pre-specified response rate of 100%, the six observational patients plus six additional patients will be enrolled and receive six weeks of treatment consisting of 50 mg of ACH-3102 and 400 mg of sofosbuvir administered once daily. Achillion anticipates that SVR4 results from the crossover cohort will be reported by the end of 2014.
Achillion Pharmaceuticals, Inc. Reports Unaudited Earnings Results for the Second Quarter and Six Months Ended June 30, 2014
Aug 7 14
Achillion Pharmaceuticals, Inc. reported unaudited earnings results for the second quarter and six months ended June 30, 2014. For the three months ended June 30, 2014, the company reported a net loss of $15.7 million compared with a net loss of $19.9 million during the same period of 2013. The company recognized no revenues for the three months ended June 30, 2014 nor any during the same period in 2013. Loss from operations was $15,766,000 against $20,113,000 a year ago. Net loss per basic and diluted share was $0.16 against $0.21 a year ago.
For the six months ended June 30, 2014, the company reported a net loss of $31.7 million, the same as the net loss of $31.7 million in the same period in 2013. There were no revenues during the first six months of 2014, and no revenues in the prior year period. Loss from operations was $32,001,000 against $31,907,000 a year ago. Net loss per basic and diluted share was $0.33 against $0.35 a year ago.
Big Pharma Has No Interest In Achillion
Jun 12 14
Big Pharma companies have so far shown no interest in acquiring Achillion Pharmaceuticals, Inc. (NasdaqGS:ACHN).
Achillion Pharmaceuticals, Inc. Announces Initiation of ACH-3422 Dosing in HCV-Infected Patients and Ability to Resume Sovaprevir Clinical Program for the Treatment of Chronic HCV
Jun 10 14
Achillion Pharmaceuticals, Inc. announced the company has begun dosing ACH-3422, a uridine-analog nucleotide polymerase inhibitor, for seven days in patients with genotype 1 chronic hepatitis C viral infection (HCV) in its ongoing Phase 1 clinical trial. Proof-of-concept results from this trial are expected to be reported during the fall of 2014. Furthermore, Achillion announced that the U.S. Food and Drug Administration (FDA) has removed the clinical hold on sovaprevir, an NS3/4A protease inhibitor, to permit the conduct of trials in patients with HCV. Sovaprevir doses of 200 mg once daily, the previously evaluated dose that was well-tolerated with clinical activity in two completed Phase 2 studies, may be used in additional therapeutic clinical trials. Sovaprevir is a Phase 2 NS3/4A protease inhibitor being developed for the potential treatment of chronic HCV infection. To date, approximately 550 subjects have been exposed to sovaprevir with clinical activity reported in two Phase 2 12-week treatment duration studies, one in combination with pegylated-interferon/ribavirin and one in combination with ACH-3102 in which the combination achieved 100% SVR12 in patients with genotype 1b HCV. The FDA removed the clinical hold to permit the conduct of therapeutic trials with a maximum of 200 mg once daily of sovaprevir in HCV patients and in single dose trials in healthy volunteers, but maintained a partial clinical hold for multiple dose studies that may be conducted in healthy volunteers, requiring prior review and approval of the protocol by the FDA. Achillion expects to continue to work collaboratively with the FDA on the continued clinical development of sovaprevir.
Achillion Might Be Next Takeover Target
Jun 9 14
Achillion Pharmaceuticals, Inc. (NasdaqGS:ACHN) could be a takeover target. Achillion shares soared 48% on speculation it would be the next target.