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.
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.
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