|Synergy CEO Gary Jacob|
Synergy Pharmaceuticals ($SGYP) handed over a fresh set of Phase III data from its second pivotal study of plecanatide, confirming the first round of positive efficacy results for chronic constipation and delivering a slightly improved safety profile that should help as the biotech makes a run at a drug approval and market launch.
The news stoked a fresh bump in the biotech's share price, which has been revved up by some persistent buyout buzz in a hyperactive market.
"Durable" responders in the plecanatide group were virtually identical in the 3-mg and 6-mg arms--20.1% and 20%--which also wound up close to the first set of data reported from their initial Phase III study last month. The placebo arm recorded a 12.8% response. On the safety side, 3.2% of patients in 3.0-mg and 4.5% of patients in 6.0-mg dose groups had to deal with diarrhea, compared to 1.3% of placebo-treated patients. That's somewhat lower than the rate reported in the first trial, which was flagged as a favorable differentiator if the drug makes its way onto the market against Ironwood's ($IRWD) Linzess.
Barclays analysts have already cheered the first round of Phase III results, noting plecanatide's somewhat lower efficacy rate against Linzess but a distinctly improved safety profile, with the Ironwood drug registering a 16% rate for diarrhea.
Synergy now says it will be ready to file for an approval in January, a little behind the Q4 schedule it had been discussing. Its shares jumped more than 25% in premarket trading, and then gave up some of those gains.
The biotech recruited close to 1,350 patients for each of the studies.
"We are thrilled with the positive results of this trial," said Synergy CEO Gary Jacob in a statement. "We now have successfully completed the two largest Phase III trials ever conducted in CIC and plecanatide's treatment effect and tolerability profile have been remarkably consistent. We look forward to filing our first NDA with plecanatide in the CIC indication and the opportunity to bring this novel treatment to market."
- here's the release