Medivir releases MIV-711-201 trial data
The trial is designed to assess the safety, tolerability and effectiveness of MIV-711 in patients with moderate knee osteoarthritis.
“The independent Data Monitoring Committee's (DMC) 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," Medivir CSO Dr. Richard Bethell said. “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."
Dr. Bethell said the company 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," he said.