Generic drug maker, Teva Pharmaceutical Industries Ltd. TEVA, announced top-line results from a phase II trial evaluating its pipeline candidate pridopidine for the treatment of patients with Huntington disease (HD).
Pridopidine is an oral small-molecule dopamine stabilizer which is being developed for the symptomatic treatment of motor disorders (including HD).
The 52-week, dose-ranging exploratory PRIDE-HD study of pridopidine twice daily versus placebo was directed at measuring improvement in motor function and the candidate’s effect on slowing down the progression of the disease. Though, medicines are presently available to treat the symptoms of HD, there are no approved drugs to alter the progression of the same.
The study revealed that certain doses of pridopidine led to a statistically significant impact on the endpoint of disease progression at 52 weeks compared to placebo. Disease progression outcomes were measured by the Total Functional Capacity (TFC) scale. In a sub-population of patients with early stage HD, the company said improvements were seen in the elements that make up TFC at 26 weeks.
The elements that make up TFC are the patient’s ability to undertake domestic chores, activities of daily living and impact on ability to manage finances.
Management believes that the PRIDE-HD study has given them a clearer idea of the dosages to study in phase III. The safety profile of the candidate was also consistent with that seen in previous studies and supported continued development.
However, “an unusually high placebo effect” limited the ability to determine treatment effects on assessments of HD motor scores.
Full results from PRIDE-HD are expected to be published in scientific journals.
According to the company’s press release, HD, a rare and fatal neurodegenerative disorder, affects about 13 to 15 individuals per 100,000 in Caucasians. Patients generally succumb to the disease within 15–25 years of diagnosis.
Earlier this week, Teva announced that it is collaborating with Intel Corporation INTC to develop a wearable device and machine learning platform that can be used for the treatment HD. Teva plans to ploy the technology in a sub-study of the PRIDE HD study by the end of 2016. Patients will be asked to use smartphones and wear smartwatches equipped with sensing technology that measures their functioning and movement. Data will be wirelessly streamed to a cloud-based platform developed by Intel for analysis.
Teva currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the generics sector include Amphastar Pharmaceuticals, Inc. AMPH and AxoGen, Inc. AXGN. While Amphastar Pharmaceuticals sports a Zacks Rank #1 (Strong Buy), AxoGen has a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
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