• Achillion Pharmaceuticals (ACHN) Phase 2a Results of Odalasvir, AL-335, and Simeprevir for Hepatitis C Viral Infection

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    Clinical and Regulatory
    Event Type: Phase 2a Results
    Timing: Q3 2016
    Designation(s): None

    This event is set for a broad date range and therefore the exact timing is unknown. This adds a degree of risk.
    FDA special designations may increase the likelihood of success and decrease the time to approval.
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    Disease and Treatment
    Disease: Infectious Disease
    Indication: Hepatitis C Viral Infection
    Lead Indication?: No
    Treatment Name: Odalasvir, AL-335, and Simeprevir

    Likelihood of event success varies depending on disease, treatment and lead indication classification.
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    Company Information
    Co. Name: Achillion Pharmaceuticals
    Stock Symbol: ACHN
    Shares Traded: NASDAQ

    The OTC BB and OTC Markets have less stringent reporting and financial requirements than the NASDAQ and NYSE. This may increase the level of risk for investors. Smaller size may have an influence on likelihood of success.
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    Event Status
    Event Outcome: Positive
    Event Discussion: Forums
    Event Announcement(s): http://ir.achillion.com/releasedetail.cfm?ReleaseID=990711
    Partnership: Yes

    Partnerships help smaller biotech companies finance the long approval process. Partnership also provides validation the clinical program may be a worthy investment.
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    Detailed Event Description from Company Announcement


    PARIS, Sept. 23, 2016 (GLOBE NEWSWIRE) -- Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) announced that updated interim results were presented today in an ePoster describing a phase 2 study being conducted by Alios BioPharma Inc., part of the Janssen Pharmaceutical Companies (Janssen) at the European Association for the Study of the Liver (EASL) Special Conference in Paris, France.

    These results, updated to include expanded safety and efficacy data, were presented in the ePoster entitled "Short duration treatment with AL-335 and odalasvir (ODV), with or without simeprevir (SMV), in treatment-naïve patients with hepatitis C virus (HCV) genotype (GT) 1 infection." It reports that 100 percent of patients receiving treatment for as short as six weeks with a triple combination of once-daily (QD) AL-335 800mg and simeprevir (SMV) 75mg with 50mg every other day (QOD) of ODV achieved a sustained viral response 12 weeks after the completion of treatment (SVR12).

    "Odalasvir has continued to show that it has the potential to shorten the treatment duration to as little as six weeks in combination with other direct acting antivirals for the treatment of HCV," commented Dr. Milind Deshpande, president and chief executive officer of Achillion. "We now look forward to seeing confirmation of these impressive data in Janssen's global development program.


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