MIV-711 Osteoarthritis Trial: Recommendation to Go Ahead

New Post Public Reply Private Reply Replies (0) Message Board

News Desk 2018

Sep 23, 2016 at 2:45 AM

MIV-711 Osteoarthritis Trial: Recommendation to Go Ahead based on independent review of safety data, and first patient enrolled in extension study

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 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. 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. About Medivir 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.

Newer

Older

Scroll down for more posts ▼

Top 10 Most Recent News Articles

Ornellaia's 2026 Harvest: Adapting to Nature's Whims

A Year Marked by Weather's Unpredictable Dance Nobody said making wine was a walk in the park, and the folks at Ornellaia know better than most how to roll with whatever nature throws their way. The 2026 harvest story is as much about unlocking the secrets of the soil as it is about navigating the quirks of the weather. Situated in Bolgheri, Italy, this year's vintage...

U. of Phoenix and LACCD Launch 3+1 Degree Pathway

Opening the Floodgates for Ambitious Community College Students When it comes to climbing the educational ladder, not everyone starts at the same rung. That's a fact we've all come to terms with in one way or another. Enter the University of Phoenix and the Los Angeles Community College District with a solution to expand educational access. The 3+1 Program: A Cost-Saving...

Gong, Agentforce, Avoma Crowned 2026 CI Champions

Diving Deep into Conversation Intelligence There's a lot to unpack when three software titans hog the spotlight, and that's exactly what's happening in the world of conversation intelligence this year. It's like we've hit the jackpot with Gong, Agentforce Sales, and Avoma carving out their turf as the 2026 Champions, according to the venerable Info-Tech Research Group....

EMCO's New Automated Facility Could Shake Industry

A Novel Leap in Production Capacity EMCO Industries just put a solid foot on the accelerator with their brand-new, shiny, fully automated plant over in Claremore, Oklahoma. If you're glancing at heavy-duty trailer springs, you can't ignore the fact that this is a multimillion-dollar investment. Heck, this monstrous 30,000-square-foot facility more than doubles what EMCO...

Wally Disrupts Dental Industry with $25M Funding

A New Breath of Fresh Air for Dental Care Dental visits—a tedious, costly affair we've all dreaded. So, when Wally rolls out an overhaul in this stale landscape, it's worth taking notice. With $25 million in their pockets from Series A funding led by Maveron, Wally's swaggering in with a plan to flip the script on dental care across the nation. Redefining the Dental...

Merit Expands in New York with Bold Acquisition Move

Merit Financial's Growth Trajectory Takes a Leap You watch the movers and shakers in this game long enough, and you start to see patterns. Merit Financial Advisors is one of those juggernauts you'd better keep an eye on. These folks just scooped up Moldenhauer & Associates—a firm that's been a staple in Orchard Park, New York—for a cool $1.1 billion worth of client...

C3EL Expands Federal Footprint with Strategic Contracts

Pushing Boundaries in Federal Contracts What a ride C3EL's had in Government Fiscal Year 2026! Let me tell you, they’ve bagged a bunch of contracts that’d make any company’s mouth water. Kicking things off, they snagged a prime cybersecurity contract from the U.S. Air Force. Considering our current cybersecurity landscape, that's like striking gold. But they...

OCI N.V. Secures a Win in Court; EGM Proceeds as Planned

OCI Dodges a Bullet in Amsterdam Court Stepping into the courtroom drama, OCI N.V. just took home a win as the Amsterdam Court of Appeal's Enterprise Chamber gave them a clean bill of health, kicking out the inquiry request from VEB and a bunch of other shareholders. The judges weren't convinced there was anything fishy going on, so they tossed the inquiry petition and...

Duke Energy's Cost-Protection Plan Shields Ratepayers

Shielding Customers From Data Center Costs Let's get right into the thick of it: Duke Energy's latest move is a strategic one, shrouded in industry terms but with a real impact on regular folks' wallets. The company's agreement with heavyweights like Amazon, Google, and Meta aims to protect existing customers in North Carolina from getting hit with the costs of powering...

HelloNation Brings 'Edvertising' to NC REALTORS® Event

HelloNation's Bold Step into Real Estate Networking October 8th to the 11th is shaping up to be a pivotal few days in Wilmington, North Carolina. Here’s the scoop: HelloNation, known for its innovative 'edvertising' model, is joining the bustling crowd at the 2026 NC REALTORS® Convention. This isn’t just any get-together—it's the grandest annual jamboree for real...