Synergy Pharmaceuticals, Inc. Reports Unaudited Consolidated Earnings Results for the Second Quarter and Six Months Ended June 30, 2015
Aug 10 15
Synergy Pharmaceuticals, Inc. reported unaudited consolidated earnings results for the second quarter and six months ended June 30, 2015. For the quarter, the company's net loss was $33.668 million or $0.34 per basic and diluted share against $25.920 million or $0.28 per basic and diluted share a year ago. Loss from operations was $26.919 million against $26.758 million a year ago.
For the six months, the company's net loss was $61.057 million or $0.62 per basic and diluted share against $42.145 million or $0.45 per basic and diluted share a year ago. Loss from operations was $49.723 million compared with $43.235 million a year ago. Net cash used in operating activities was $49.0 million as compared to $39.5 million a year ago.
Synergy Pharmaceuticals Announces Positive Results in the Second Phase 3 Trial of Plecanatide in Patients with Chronic Idiopathic Constipation
Jul 30 15
Synergy Pharmaceuticals Inc. announced positive results from the second of two pivotal phase 3 clinical trials evaluating the efficacy and safety of two different plecanatide treatment doses (3.0 mg and 6.0 mg), taken as a tablet once-a-day, in 1,337 adult patients with chronic idiopathic constipation (CIC). Preliminary analysis of the data indicates that both plecanatide 3.0 mg and 6.0 mg 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 (20.1% in 3.0 mg and 20.0% in 6.0 mg dose groups compared to 12.8% in placebo; p=0.004 for both doses). The durable overall responder endpoint is the current FDA endpoint required for US approval in CIC. Importantly, plecanatide was safe and well tolerated at both doses; the most common adverse event was diarrhea, which occurred in 3.2% of patients in 3.0 mg and 4.5% of patients in 6.0 mg dose groups compared to 1.3% of placebo-treated patients. Stool consistency was the key secondary endpoint reported with analyses; both 3.0 mg and 6.0 mg plecanatide doses showed statistically significant improvement from baseline in Bristol Stool Form Scale (BSFS) scores compared to placebo (mean increase of 1.49 in 3.0 mg and 1.50 in 6.0 mg dose groups compared to a mean increase of 0.87 in placebo; p<0.001 for both doses). The observed improvements began at Week 1, continued throughout the 12-week treatment period, and returned towards baseline with no indication of an exaggerated or rebound effect following discontinuation of treatment. 20 patients in the trial (1.4%) experienced serious adverse events but there was no imbalance across treatment groups in either incidences or individual serious adverse events. Overall, the rates of withdrawal from treatment because of an adverse event were low (3.2% in 3.0 mg and 3.8% in 6.0 mg dose groups compared to 3.0% in placebo) and discontinuations due to diarrhea were infrequent (1.1% in 3.0 mg and 1.1% in 6.0 mg dose groups compared to 0.4% in placebo). No clinically relevant abnormalities were observed in serum chemistries, hematology, urinalysis, ECG or vital signs measurements. Synergy plans to present additional data results from both phase 3 CIC trials at appropriate scientific conferences. The company plans to file its first new drug application (NDA) with plecanatide in the CIC indication in January 2016. The plecanatide phase 3 CIC program included two randomized, 12-week, double-blind, placebo-controlled pivotal trials that evaluated the efficacy and safety of two different plecanatide treatment doses (3.0 mg and 6.0 mg), taken as a tablet once-a-day, in patients with CIC. Both trials included a two-week pre-treatment baseline period, a 12-week treatment period, and a two-week post-treatment period. The phase 3 CIC program was designed to support regulatory submission in the U.S. The second phase 3 CIC trial was conducted in the United States and assessed 1,337 adult patients (21.6% males and 78.4% females) that were randomly assigned to take 3.0 mg or 6.0 mg plecanatide or placebo once-a-day during the 12 week treatment period (443 patients in the 3.0 mg dose group, 449 patients in the 6.0 mg dose group and 445 patients in the placebo group). The first phase 3 CIC trial was conducted in North America and assessed 1,346 adult patients (19.2% males and 80.8% females) that were randomly assigned to take 3.0 mg or 6.0 mg plecanatide or placebo once-a-day during the 12 week treatment period (453 patients in the 3 mg dose group, 441 patients in the 6.0 mg dose group and 452 patients in the placebo group). The primary endpoint for both trials was the proportion of durable overall responders (%), which is the current regulatory endpoint required for U.S. approval in CIC. The FDA has defined a durable overall responder as a patient who fulfills both > 3 complete spontaneous bowel movements (CSBMs) per week plus an increase of > 1 CSBM from baseline in the same week, for 9 out of the 12 treatment weeks. In addition, the same patient must be an overall responder for at least 3 of the last 4 treatment weeks in order to be considered a durable overall responder. Plecanatide would be the first drug approved for CIC using the more stringent regulatory requirement for durability in the response. Patients were selected using Rome 3 criteria modified for CIC and had fewer than 3 defecations per week, loose stools occurring rarely without laxatives, inadequate criteria for irritable bowel syndrome with constipation (IBS-C), and at least two of the following applied to at least 25% of defecations: straining during evacuation, lumpy or hard stools, sensation of anorectal obstruction or blockage. Rome 3 requires patients to fulfill the criteria for the last 3 months with symptom onset at least 6 months prior to diagnosis.
Synergy Pharmaceuticals, Inc. Presents at 35th Annual Canaccord Genuity Growth Conference, Aug-13-2015 11:30 AM
Jul 9 15
Synergy Pharmaceuticals, Inc. Presents at 35th Annual Canaccord Genuity Growth Conference, Aug-13-2015 11:30 AM. Venue: InterContinental Boston, 510 Atlantic Avenue, Boston, MA 02210, United States. Speakers: Gary S. Jacob, Chairman, Chief Executive Officer and President.