The company announced positive top-line results from the first of two pivotal Phase 3 clinical trials evaluating the efficacy and safety of two different plecanatide treatments, taken as a tablet once a day, in 1,346 adult patients with chronic idiopathic constipation (CIC).
Both plecanatide 3.0 mg and 6.0 mg doses met the study’s primary endpoint, according to preliminary analysis. At the same time, it demonstrated statistical significance in the proportion of patients in the intention-to-treat population who were durable overall responders compared to placebo during the 12-week treatment period.
Gary S. Jacob, Ph.D., chairman and CEO of Synergy, commented on this release:
We are very pleased with these results and how well they confirm earlier plecanatide data observed in the phase 2b/3 trial. These results strengthen our belief that plecanatide has the potential to not only effectively treat constipation but with a durability and tolerability profile that is ideal for chronic use. We look forward to the results of our second pivotal trial in the coming weeks.
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In the trial, 15 patients, about 1%, experienced serious adverse events, but there was no imbalance across treatment groups in either incidences or individual serious adverse events.
Looking forward, Synergy has plans to announce top-line data results from the second Phase 3 CIC trial with plecanatide in the first half of the third quarter of 2015. Also the company plans to file its first new drug application (NDA) with plecanatide in the CIC indication in the fourth quarter of this year.
It would appear that Synergy has all the cash it needs going forward to complete this trial and make it to the big leagues. At the end of March 2015, the company had roughly $79 million in cash and cash equivalents. It also has 200 million in long-term debt, which appears to have been taken out in the third quarter of 2014.
Shares of Synergy were up about 46.5% at $6.80 Wednesday morning, in a 52-week trading range of $2.45 to $6.91. This marks the newest multiyear high for Synergy dating back to April 2013, but shares appear to be subtly backing off from this level.
The stock has a consensus analyst price target of $8.25, and the company has a market cap of roughly $670 million.
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