Stockholm, Sweden — 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
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
Further information on the trial planning and conduct can be found on
www.clinicaltrials.gov with identifier NCT02705625.
For further information, please contact:
Richard Bethell, CSO Medivir AB, mobile +46 (0)72-704 3211
Ola Burmark, CFO Medivir AB, mobile: +46 (0) 725 480 580
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 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.GlobeNewswireglobenewswire.com
Last updated on: 26/09/2016