Shares rocket as Synergy's plecanatide meets Phase III endpoints in CIC

US biopharma company Synergy Pharmaceuticals (Nasdaq: SGYP) saw its shares leap 47% to $6.80 in premarket trading on Wednesday, as the company released positive late-stage trial data with its constipation drug candidate and amid speculation that it could become a takeover target.

Synergy announced positive top-line results from the first of two pivotal Phase III clinical trials evaluating the efficacy and safety of two different plecanatide treatment doses (3.0mg and 6.0mg), taken as a tablet once-a-day, in 1,346 adult patients with chronic idiopathic constipation (CIC).

Preliminary analysis of the data indicates that both plecanatide 3.0mg and 6.0mg doses met the study’s primary endpoint and 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 (21.0% in 3.0mg and 19.5% in 6.0mg dose groups compared to 10.2% in placebo; p<0.001 for both doses). The durable overall responder endpoint is the current FDA (Food and Drug Administration) endpoint required for US approval in CIC.