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    Medivir to Continue MIV-711 Osteoarthritis Trial

    Chelsea Pratt
    Sep. 23, 2016 01:20AM PST
    Life Science Investing News

    Medivir today announces new information about its phase IIa program for the treatment of osteoarthritis.

    Medivir AB (Nasdaq Stockholm: MVIR) today announces new information about its phase IIa program for the treatment of osteoarthritis: The independent Data Monitoring Committee (DMC) has recommended continuation of the ongoing randomized, double-blind phase IIa study (MIV-711-201) based on a review of unblinded safety data.
    · The first patient has been enrolled into an open label phase IIa
    extension study, MIV-711-202.
    The objective of MIV-711-201 is to evaluate the safety, tolerability and
    efficacy of six months of treatment with MIV-711 in patients with
    moderate knee osteoarthritis. As part of the study, an independent DMC
    is periodically scheduled to review the unblinded safety data from the
    trial. The DMC’s voting members are two expert physicians and one
    biostatistician. The possible recommendations from such a review, based
    on the analysis of the accumulated safety data, could be 1) Go ahead, 2)
    Go ahead but with modification, 3) Suspend enrollment or 4) Stop
    enrollment. Based on the review of the accumulated safety data after the
    first 50 subjects had completed three months of treatment, the DMC has
    recommended that the phase IIa trial of osteoarthritis should go ahead.
    In addition, the first patient has been enrolled in an open label
    extension study that will enroll approximately 50 patients from
    MIV-711-201. All patients in the study will receive 200mg MIV-711 once
    daily. Patients will be eligible to roll over into the extension if they
    have a favorable response to MIV-711 treatment, or if their disease has
    worsened following placebo treatment. The first objective of the study
    is to assess the safety and tolerability of six additional months of
    treatment with MIV-711, as well as its effect on knee joint structure
    assessed using magnetic resonance imaging (MRI), in patients who have
    shown evidence of a response to MIV-711 treatment. The other objective
    of the study is to explore the safety, tolerability and efficacy of six
    months of treatment with MIV-711 in patients previously on placebo whose
    osteoarthritis has worsened over the preceding six month period.
    It is expected that data from MIV-711-201 will be available in the
    second half of 2017 and that data from the extension study will be
    available in the first half of 2018.
    “The DMC’s recommendation to continue MIV-711-201 as planned based on
    the unblinded assessment of the available safety data is an encouraging
    milestone for MIV-711 and has enabled us to start the MIV-711-202
    extension study”, says Dr Richard Bethell, CSO at Medivir. “The DMC
    ruling confirms and extends the phase I data, which indicated that
    MIV-711 has a favorable safety profile. Long term safety will be of
    particular importance for disease modifying OA drugs (DMOADs) such as
    MIV-711, since OA patients require long term treatment and are
    frequently burdened by co-morbidities. We will continue to closely
    monitor the safety profile throughout the course of these studies. We
    are also excited by the opportunity to obtain longer-term safety,
    tolerability and efficacy data on MIV-711 in patients who have shown
    evidence of a response to treatment, while at the same time studying the
    drug in patients from the placebo arm of MIV-711-201 whose disease
    worsened over a six-month period as these patients may be in particular
    need of a disease-modifying treatment”.
    MIV-711 is being developed as a DMOAD, i.e. a drug to slow or reverse
    the progressive degeneration of joints affected by OA. There are no
    DMOADs approved for use currently, and the standard of care for OA
    patients is based on analgesics , with the potential for associated side
    effect risks such as GI-bleeding and opioid dependency, and changes in
    life style. DMOADs for osteoarthritis therefore represent a very large
    and attractive market opportunity. Medivir estimates that the US market
    alone is greater than USD 6 billion annually for a drug that impacts
    disease progression, even if its use was restricted just to patient
    populations with moderate osteoarthritis in weight-bearing joints.
    Further information on the trial planning and conduct can be found on www.clinicaltrials.gov
    with identifier NCT02705625.
    Medivir is required under the Securities Markets Act to make the
    information in this press release public. The information was submitted
    for publication at 8.30 CET on 23 September 2016.
    About Medivir
    Medivir (STO:MVIRB) is a research based pharmaceutical company with a
    research focus on oncology and infectious diseases. We have a leading
    competence within protease inhibitor design and nucleotide/nucleoside
    science and we are dedicated to develop innovative pharmaceuticals that
    meet great unmet medical need. Our commercial organization provides a
    portfolio of specialty care pharmaceuticals on the Nordic market.
    Medivir is listed on the Nasdaq Stockholm Mid Cap List.
    This information was brought to you by Cision https://news.cision.com

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