Almost every week, biopharma companies release results from ongoing clinical trials. Here’s a roundup of some of the top clinical trial news from the previous week.
- AveXis, a Novartis company, released interim data from the Phase I STRONG trial, additional data from the STR1VE trial, and the first data from the Phase III SPR1NT trial for Zolgensma (onasemnogene abeparvovec-xioi) in spinal muscular atrophy (SMA) Type 1. Zolgensma is a gene therapy in development as a one-time infusion for SMA Type 1. It uses a virus vector to deliver a copy of the human SMA gene. SMA is a severe neuromuscular disease noted by the loss of motor neurons, which leads to progressive muscle weakness and paralysis.
- Neurocrine Biosciences presented data from two Phase III clinical trials of opicapone, a once-daily, oral catechol-O-methyltransferase (COMT) inhibitor for Parkinson’s disease. They found that patients receiving opicapone 50 mg with levodopa, the standard of care, had a significant and sustained improvement in symptoms. Neurocrine reported on two Phase III studies, BIPARK-1 and BIPARK-2. BIPARK-1 looked at about 600 patients with Parkinson’s and motor fluctuations. BIPARK-2 looked at about 400 patients with Parkinson’s and motor fluctuations. They received once-daily doses of opicapone of either 25 mg or 50 mg or placebo for 14 to 15 weeks. The data from these two Phase III trials showed that adding once-daily opicapone to levodopa significantly increased ON time without troublesome dyskinesia.
- Urovant Sciences presented Phase III data at the 2019 American Urological Association Annual Meeting (AUA). The drug is being evaluated in adults with overactive bladder. The EMPOWUR trial showed statistical significance with the drug over placebo in reducing daily urge urinary incontinence (UUI) episodes and reduction in daily micturitions. The company expects to file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) by early 2020.
- Eli Lilly presented results from the Phase III EVOLVE-1 and EVOLVE-2 studies in Emgality (galcanezumab-gnlm) in monthly migraine headaches at the Annual Meeting of the American Academy of Neurology (AAN). Emgality was approved by the FDA in September 2018 for prevention of migraine in adults. These two studies stratified patients by frequency of migraine and evaluated two different doses of the drug for its ability to reduce the different subgroups’ headache frequency.
- UroGen announced results from a secondary analysis of its Phase III OLYMPUS trial of UGN-101 (mitomycin gel) in patients with endoscopically unresectable low-grade upper tract urothelial cancer (UTUC). The results were presented at the American Urological Association Annual Meeting. Patients in the study showed a 59% complete response rate, at least in a subset of patients. Of the evaluated complete responses, 27 patients have had a six-month evaluation, and 24 out of 27, or 89%, are disease-free at six months. Overall, 5 out of 41 patients who achieved a complete response have relapsed at any time during the study.
- Biogen presented data at the AAN meeting showing that its Spinraza (nusinersen) had a durable treatment effect in patients with SMA. Babies receiving the drug were followed up to four years. The infants showed additional or new motor function improvements during that period. These were the results of two trials, SHINE and NURTURE.
- Merck & Company announced it had positive results in a Phase III clinical trial evaluating Belsomra (suvorexant) for insomnia in patients with mild-to-moderate Alzheimer’s disease dementia. Merck presented the data at the AAN Annual Meeting. The trial looked at the efficacy and safety of Belsomra 10 mg, which could be increased to 20 mg based on patient’s response, compared to placebo in patients with mild-to-moderate Alzheimer’s dementia who also had insomnia. The trial met both primary and secondary efficacy endpoints. Belsomra improved mean total sleep time (TST) by 28.2 minutes compared to placebo at 4 weeks, which was the primary endpoint. This...
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