PharmGPS Validations

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Trulance (IBS-C)

TRULANCE: SNDA FILING FOR TRULANCE
(Segment:IBS with constipation (IBS-C); Phase: Filed; Company: Synergy Pharmaceuticals)
March 27th 2017; Synergy pharmaceuticals submits supplemental new drug application (sNDA) for
Trulance (plecanatide) for the treatment of adults with irritable bowel syndrome with constipation (IBS-C)

Performance Benchmark Linzess

Trulance 3.75, 2.95 3 3
Linzess EFFICACY
SAFETY
2.325, 2.4 2.825, 2.65 SOC
A3309

Trulance
2.475, 2.05

YKP10811 Trulance

1.912, 1.55

Linzess Trulance Trulance 23 22
Phase II analysis Filed analysis EFFICACY SAFETY
Phase II analysis Filed analysis

In March 2017 Synergy Pharmaceuticals Inc. announced that the company has submitted a supplemental New
Drug Application (sNDA) for TRULANCE™ (plecanatide) for the treatment of adults with irritable bowel syndrome
with constipation (IBS-C). The application is based on data from two randomized, 12-week, double-blind,
placebo-controlled Phase 3 studies evaluating the efficacy and safety of TRULANCE for the treatment of adults
with IBS-C. In both trials, TRULANCE 3 mg and 6 mg doses met the primary endpoint showing statistical
significance in the percentage of patients who were Overall Responders compared to placebo during the 12-week
treatment period. (Study 1: 21.5% in 3 mg and 24.0% in 6 mg dose groups compared to 14.2% in placebo; p=0.009
for 3 mg and p<0.001 for 6 mg; Study 2: 30.2% in 3 mg and 29.5% in 6 mg dose groups compared to 17.8% in
placebo; p<0.001 for 3 mg and p<0.001 for 6 mg)

PharmGPS Prediction: The recent sNDA filing of Trulance has validated the analysis done by
PharmGPS as the molecule was rated as one of the top contenders for IBS-C just next to Linzess
as early as in early phase II.

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