Latest New Medical Therapy Trial Results
Following are the most recent results for new drug therapies currently in clinical trials worldwide. Results
are also searchable by therapeutic area beginning with the most recent updates.
Week of August 29, 2016
Antibe Therapeutics issued results of a phase II trial of ATB-346 as a treatment of osteoarthritis (OA). Twelve patients with OA of the knee were treated once daily for 10 days with ATB-346 at a dose of 250mg. This dose of ATB-346 contains one-sixth of the typical daily dose of naproxen for treating OA. This lower dose was very effective at reducing pain, and equal to or better than naproxen or celecoxib in comparable studies. The patients recorded their level of pain one day prior to starting treatment and again on days four and 10 of treatment. The “WOMAC pain scale” was used as the measure of beneficial effect, since it is the gold standard in arthritis clinical trials. In this trial, a once daily dose of ATB-346 produced a reduction of the WOMAC pain score of 4.3 units on day four, increasing to 7.6 units on day 10, with a very high level of statistical significance in comparison to baseline pain (p<0.001). The drug was also safe and well-tolerated. ATB-346 has only one possibly drug-related adverse event, an allergic reaction graded as mild by the study’s supervising physician.
Heron Therapeutics issued results of a phase II study of HTX-011 for the management of post-operative pain in patients undergoing bunionectomy. Study 208 was a randomized, placebo- and active-controlled, double-blind study. There was a 66% reduction in pain as measured by SPI 0-24 when comparing HTX-011 administered by infiltration to placebo (p<0.0001). There was a 64% reduction in pain as measured by Summed Pain Intensity (SPI) score in the first 24 hours post-surgery (SPI 0-24) when comparing HTX-011 administered by infiltration to bupivacaine solution (p<0.0001). There was a 69% reduction in pain as measured by SPI 0-24 when comparing HTX-011 administered by nerve block to placebo (p<0.0001). There was a 71% reduction in pain as measured by SPI 0-24 when comparing HTX-011 administered by nerve block to bupivacaine solution (p<0.0001). Significant reductions in pain were maintained through 96 hours post-surgery (SPI 0-96) for all groups: HTX-011 by infiltration versus placebo (p=0.005), HTX-011 by infiltration versus bupivacaine solution (p=0.019), HTX-011 by nerve block versus placebo (p=0.004) and HTX-011 by nerve block versus bupivacaine solution (p=0.007). Mean time to first opioid rescue medication was 716% longer than for placebo (p<0.0001) and 167% longer than for bupivacaine solution (p<0.036). Over the first 24 hours post-surgery, patients receiving HTX-011 consumed 74% less opioids than placebo patients (p<0.0001) and 67% less than bupivacaine solution patients. Over the first 96 hours post-surgery, patients receiving HTX-011 consumed 53% less opioids than placebo patients (p=0.003) and 50% less than bupivacaine solution patients (p=0.008). The company intends to advance HTX-011 into phase III trials.
pSivida reported results of a phase III trial of Medidur in non-infectious uveitis. pSivida is conducting two phase III trials to assess the safety and efficacy of Medidur for the treatment of posterior uveitis. These are randomized, sham-controlled, double-masked trials. The primary endpoint of both trials is recurrence of posterior uveitis at six months, with patients in both trials followed for three years. The first phase III Medidur trial, which fully enrolled with 129 patients in 16 centers in the U.S. and 17 centers outside the U.S., met its primary efficacy endpoint, prevention of recurrence of disease at six months, with high statistical significance (p<0.00000001, intent to treat analysis) maintained through 12 months. The second trial, which will include up to 150 patients in approximately 15 centers in India, is currently being enrolled.
Radius Health issued results of a phase III trial of abaloparatide for the treatment of postmenopausal women with osteoporosis. The randomized, double-blind, placebo-controlled, comparative, multicenter, 18-month international study enrolled 2,463 women. The study was designed to evaluate the efficacy and safety of the investigational drug abaloparatide-SC 80mcg to reduce the risk of vertebral and nonvertebral fractures. The ACTIVE results showed that patients treated with daily abaloparatide for 18 months had a significantly greater reduction in the incidence of new vertebral fractures (p<0.001) and nonvertebral fractures (p=0.049) compared to placebo. An NDA for abaloparatide is currently under review by the FDA.