ACH-3422
/ J&J, AstraZeneca
- LARVOL DELTA
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March 07, 2014
Achillion reports 2013 fourth quarter and year-end financial results
(Achillion Press Release)
- Anticipated completion of P1 drug-drug interaction study evaluating ACH-3102 and ACH-2684 in Q2 2014; Anticipated initiation of P2 trial evaluating ACH-3102 with ACH-2684 in Q2 2014; Anticipated initiation of P1 trial with ACH-3422 outside US in Q2 2014; Anticipated initiation of clinical trial with ACH-3422 in combination with other agents by the end of 2014; Anticipated initiation of P2 trial in Q2 2014 with ACH-3102 and sofosbuvir for durations of 8 weeks and less for the treatment of genotype 1 HCV; Anticipated submission and response from the FDA regarding the clinical hold on sovaprevir in H1 2014. "For the year ended December 31, 2013, the Company reported a net loss of $59.0 million, compared to a net loss of $47.1 million in 2012."
Anticipated FDA event • Anticipated new P1 trial • Anticipated new P2 trial • Anticipated new trial • Anticipated trial completion date • Commercial • Hepatitis C Virus
May 23, 2014
Investigational nucleoside and nucleotide polymerase inhibitors and their use in treating hepatitis C virus
(Expert Opin Investig Drugs)
- "Currently, mericitabine has the most robust data but its efficacy appears to be less than optimal. Other drugs such as ALS-2200 (and its diastereomer VX-135) and BMS-986094 are promising but the data in humans are too scanty to draw conclusions about their future role at this current point in time."
Review • Hepatitis C Virus
March 05, 2015
Achillion reports 2014 fourth quarter and year-end financial results
(Achillion Press Release)
- "Plan to initiate in the first half of 2015 a clinical trial with ACH-3422 in combination with ACH-3102 for patients with treatment-naïve genotype 1 HCV...SVR4 results are expected in the second half of 2015...Plan to initiate during the first quarter a Phase 1 proof-of-concept trial evaluating the anti-viral activity of ACH-3422 for HCV genotypes 2 and 3. Results are anticipated during the second quarter of 2015....Expect to initiate during the first half of 2015 a proxy triplet trial evaluating ACH-3102 and sovaprevir with sofosbuvir...SVR4 results are expected in the second half of 2015; and Expect to initiate by the end of 2015 a pharmacokinetic and viral kinetic study of ACH-3422, ACH-3102 and sovaprevir in patients with treatment-naïve genotype 1 HCV."
Anticipated new P1 trial • Anticipated new P2 trial • Anticipated P1 data • Anticipated P2 data • Hepatitis C Virus
March 08, 2014
Achillion: Cowen & Company Healthcare Conference
(Achillion)
- Anticipated initiation of P2 ACH-3422 + ACH-3102 +/- ACH-PI (triple regimen) trial in hep C infection in early 2015
Anticipated new P2 trial • Hepatitis C Virus
December 28, 2014
Best Performing 2014 Small Cap Pharmaceutical Stocks: ACHN, PTX & FOLD
(SmallCap Network)
- "...We expect to report top-line results from our ongoing Phase 1 trial of ACH-3422 later this quarter and look forward to initiating a proprietary combination program evaluating ACH-3422, ACH-3102 and sovaprevir during 2015."
Anticipated P1 data • Hepatitis C Virus
February 13, 2015
Achillion: Corporate Presentation
(Achillion)
- Anticipated presentation of data from P1 proof of concept trial in hepatitis C infection in H1 2015; Anticipated initiation of P2 SPARTA doublet program in combination with ACH-3102 for hepatitis C infection in H1 2015; Anticipated data from P2 SPARTA doublet trial in combination with ACH-3102 for hepatitis C infection in H2 2015; Anticipated initiation of multi-dose pharmacokinetic study in combination with ACH-3102 and sovaprevir for hepatitis C infection in H2 2015
Anticipated new P2 trial • Anticipated new trial • Anticipated P1 data • Anticipated P2 data • Hepatitis C Virus
January 13, 2014
Achillion reports HCV pipeline progress and outlines 2014 HCV milestones
(Achillion Press Release)
- Anticipated initiation of P1 first-in-human trial ex-US in Q2 2014 and P1 proof-of-concept trial in mid-2014 for ACH-3422 in HCV pts; Anticipated initial results from HCV-infected patients in Q3 2014 for ACH-3422; Anticipated initiation of pilot P2 study early in Q2 2014 for ACH-3102 + sofosbuvir in treatment-naive HCV pts; Anticipated initiation of P2 combination study for ACH-3422 by year-end 2014; Anticipated initiation of P2 trial early 2015 for ACH-3422 + ACH-3102 ± NS3/4A protease inhibitor in treatment-naive HCV pts; Anticipated initiation of P1 drug-drug interaction study in Q1 2014 and anticipated initiation of proof-of-concept study in mid-2014 for ACH-3102 + ACH-2684; Anticipated complete response package on the previously disclosed sovaprevir clinical hold and anticipated response from the FDA by the end of H1 2014.
Anticipated FDA event • Anticipated new P1 trial • Anticipated new P2 trial • Hepatitis C Virus
June 10, 2014
Achillion announces initiation of ACH-3422 dosing in HCV-infected patients and ability to resume sovaprevir clinical program for the treatment of chronic HCV
(Achillion Press Release)
- "Achillion...has begun dosing ACH-3422...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....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."
Anticipated P1 data • Enrollment status • FDA event • Hepatitis C Virus
December 13, 2013
Achillion: Oppenheimer Healthcare Conference
(Achillion)
- Anticipated launch of ACH-3422 + ACH-3102 +/- ACH-PI triple combo for hep C infection in 2016/2017
Anticipated launch • Hepatitis C Virus
April 30, 2014
Achillion advances ACH-3422, uridine-analog nucleotide inhibitor, into clinical trial; Initiates phase 2 pilot study with ACH-3102, NS5A inhibitor, for HCV
(Achillion Press Release)
- P2, N=12; P1, N=100; "Achillion...announced that is has begun dosing study participants with ACH-3422, Achillion's proprietary uridine-analog nucleotide inhibitor, in a Phase 1 clinical trial....Achillion also announced the initiation of dosing in a Phase 2 pilot study evaluating ACH-3102...in combination with sofosbuvir for eight and potentially six weeks of treatment for patients with chronic genotype 1 treatment-naïve HCV." Anticipated P1 results during fall of 2014; Anticipated P2 results during summer of 2014."
Anticipated P1 data • Anticipated P2 data • New P1 trial • New P2 trial • Phase shift • Hepatitis C Virus
July 25, 2015
Achillion: Clinical Trial Update
(Achillion)
- “ACH-3422 achieved dose-related virologic responses in GT-1 HCV-infected patients. In the 6 patients who received 700 mg QD for 14 days, mean maximal reduction from baseline was 4.6 log
10
, including 3 patients with target not detected”; “In all HVs and patients infected with HCV who received active treatment through 700mg QD, AC-3422 was safe and well-tolerated with no treatment-related SAEs, AE-related discontinuations, or clinically significant laboratory or ECG abnormalities”
P1 data • Hepatitis C Virus
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