sovaprevir (ACH 1625) / AstraZeneca - LARVOL DELTA

In silico identification of strong binders of the SARS-CoV-2 receptor-binding domain. (PubMed, Eur J Pharmacol) - "According to our screening and selection criteria, three approved antivirals (elbasvir, grazoprevir, and sovaprevir) and 4 other drugs (hesperidin, pamaqueside, diosmin, and sitogluside) were identified as potent binders of the RBD. Furthermore, this study also discussed the pharmacological action of the 4 non-antiviral drugs on hematological and neurological disorders that, in addition to inhibiting the viral entry, could be beneficial against the neurological disorders identified in COVID-19 patients. Besides, six other small-molecules were identified, with no pharmacological description so far, exhibiting strong binding affinities to the RBD that we believe worth being investigated as inhibitors of the SARS-CoV-2-receptor interaction."

Journal • CNS Disorders • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

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

Safety, tolerability and antiviral activity of ACH-0141625 or placebo in combination with peginterferon and ribavirin in HCV positive subjects (clinicaltrials.gov) - P2, N=124; Recruiting -> Active, not recruiting; Completion date: Jan’13 -> Apr ‘13

Completion date • Enrollment closed • Hepatitis C Virus

Achillion: Pipeline Update (Achillion) - Anticipated completion of P2 trial for genotypes 2, 3, 4 treatment-naive HCV in Q2 2014; Anticipated initiation of P2 Cirrhotic trial in HCV patients with compensated cirrhosis in Q4 2013; Anticipated completion of P2 Cirrhotic trial in HCV patients compensated cirrhosis in Q4 2013; Anticipated initiation of Apollo-C P2b (sovaprevir + ACH-3102 combo) trial for genotype 1a/b tx-naive HCV patients in Q4 2013; Anticipated completion of Apollo-C P2b (sovaprevir + ACH-3102 combo) trial for genotype 1a/b tx-naive HCV patients in Q2 2014

Anticipated new P2 trial • Anticipated trial completion date • Hepatitis C Virus

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

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

Oppenheimer Healthcare Conference (Achillion) - "200 mg; 400 mg; or 800 mg QD dosing achieved robust efficacy."

P2a data • Hepatitis C Virus

Safety, tolerability and efficacy of 12-weeks of sovaprevir, ACH-3102 and ribavirin in treatment-naive GT-1 HCV subjects (clinicaltrials.gov) - P2, N=50; Sponsor: Achillion; Recruiting -> Active, not recruiting.

Enrollment closed • Hepatitis C Virus

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

Achillion: Corporate Presentation (Achillion) - "Highlights of Clinical Results"; "ACH-3102 + Sovaprevir Phase 2 Trial"; "Combination of ACH-3102+Sovaprevir results is very rapid reduction in viral clearance"; "All subjects achieve HCV RNA level <LOQ in less than two weeks: Shortest time to clear HCV RNA as compared to other regimens, Time to clear HCV RNA is important to shorten treatment duration"

P2 data • Hepatitis C Virus

Achillion: UBS Global Healthcare Conference (Achillion) - "ACH-3102 + Sovaprevir + RBV Phase 2 Study"; "Achieved 100% SVR24 in GT1b Patients"; "100% of GT1b patients achieved SVR24 despite the presence of baseline RAVs, including the Y93H mutation in NS5A"

P2 data • Hepatitis C Virus

Achillion: Corporate Presentation (Achillion) - Anticipated composition of matter patent protection through 2029

Anticipated patent expiry • Hepatitis C Virus

Achillion initiates phase 2 interferon-free trial of sovaprevir and ACH-3102 for genotype 1 HCV (Achillion) - P2, N=50; 007 trial; Sponsor: Achillion; "Achillion ...has initiated an international Phase 2 clinical trial with sovaprevir and ACH-3102 ...'Achillion looks forward to reporting...RVR results from the -007 sovaprevir and ACH-3102 study during the third quarter of this year, as well as providing the updated SVR results later this month from our safety and tolerability study of ACH-3102 and ribavirin for the treatment of genotype 1b HCV.'"

Anticipated P2 data • New P2 trial • Hepatitis C Virus

Achillion: Bank of America Merrill Lynch Healthcare Conference (Achillion) - Anticipated rapid virological response data from P2a (sovaprevir+ACH-3102+rbv) 007 trial for hep C infection in Q3 2013; Anticipated sustained virological response data from P2a (sovaprevir+ACH-3102+rbv) 007 trial for hep C infection in Q4 2013; Anticipated sustained virological response data from P2a (sovaprevir+ACH-3102) trial for genotype 1 hep C infection in fall 2013

Anticipated P2a data • Hepatitis C Virus

Achillion announces oral presentations given at APASL 2014 detailing clinical activity of ACH-3102, second-generation NS5A inhibitor, against genotype 1b HCV (Achillion Press Release) - P2, N=8; P2, N=50; NCT01849562; Sponsor: Achillion; "Achillion...announced that two oral presentations were made at the 23rd Asian Pacific Association for the Study of the Liver (APASL) Conference 2014 in Brisbane, Australia. Updated Phase 2 clinical trial results evaluating a 150 mg loading dose followed by 50 mg once daily of ACH-3102 in combination...sovaprevir and twice daily ribavirin showed that 100% of patients achieved SVR12 (n=8) including subjects who had Y93 mutations at baseline. A second oral presentation on ACH-3102 was made at APASL 2014 that discussed clinical virology...observed in the novel Phase 2 clinical trial evaluating ACH-3102 with ribavirin for patients with treatment-naïve genotype 1b HCV."

P2 data • Hepatitis C Virus

Achillion: Oppenheimer Healthcare Conference (Achillion) - "Very rapid reduction in HCV RNA demonstrated with sovaprevir + ACH-3102 + RBV in GT1: All GT1 subjects achieved vRVR, defined as an HCV RNA <25 IU/mL by week 2"; "Potent anti-viral activity demonstrated against GT1b: 100% RVR in the 200mg and 400mg dose groups; All subjects achieved HCV RNA <10 IU/ml at week 4; Subject with the Y93H mutation at baseline, which is highly resistant to first-generation NS5A inhibitors, achieved RVR"; "RVR was achieved in 79% of GT1 subjects overall"

P2 data • Hepatitis C Virus

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

Achillion provides pipeline update (Achillion Press Release) - P2, N=50; NCT01849562; Sponsor: Achillion; "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....'With...ACH-3102, we are in a position to rapidly initiate combination studies with ACH-2684, our protease inhibitor, with results expected in 2014....ACH-3422, with which we anticipate initiating clinical trials in the first half of 2014....Phase 2 -007 Trial...All patients achieved a very rapid virologic response (vRVR) with HCV RNA less than 25 IU/ml by week 2...RVR was achieved in 79% of GT1 patients overall."

Anticipated new P1 trial • Anticipated P2 data • FDA event • P2 data • Hepatitis C Virus

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

Achillion: JMP Securities Healthcare Conference (Achillion) - Anticipated P2 interim data including SVR4 for ACH3102 + sofosbuvir study for hep C infection during summer 2014

Anticipated P2 data • Hepatitis C Virus