April 9, 2018
Allergan and Gideon Richter announced positive topline results for RGH-MD-53, a Phase III study of cariprazine for the treatment of adults with major depressive episodes associated with bipolar I disorder (bipolar I depression). RGH-MD-53 and RGH-MD-54 were identical Phase III, randomized, double-blind, placebo-controlled, parallel-group, multicenter, fixed-dose clinical trials in adult patients with bipolar I depression. A total of 584 patients were randomized to evaluate the efficacy, safety and tolerability of cariprazine 0.75 mg, 1.5 mg and 3 mg compared to placebo in the treatment of outpatients with bipolar I depression. Patients underwent a no-drug screening period of approximately 7-14 days, followed by 8 weeks of double-blind treatment and a one-week, no investigational product safety follow-up period. Cariprazine was generally well tolerated in the trial. The overall incidence of patients who experienced adverse events was 51 percent for the cariprazine 1.5 and 3 mg dose groups, and 46 percent for the placebo group. The majority of adverse events were mild to moderate and led to discontinuation in approximately 5 percent of cariprazine-treated patients versus three percent of placebo-treated patients.
Synlogic Doses First Patient in Phase Ib/IIa Trial
Synlogic announced that the first patient was dosed in its Phase Ib/IIa clinical trial of SYNB1020. This randomized, double-blind, placebo-controlled study is designed to evaluate the safety and tolerability of SYNB1020, as well as its ability to lower blood-ammonia levels in patients with cirrhosis and elevated blood ammonia. This Phase Ib/IIa study had two parts. In Part I of the trial, an initial sentinel open-label cohort of subjects with cirrhosis and a Model for End-Stage Liver Disease (MELD) score <12 received orally administered SYNB1020 (5 x 1011 CFU TID) for six days. Part 2 of the trial comprised a randomized, double-blinded, placebo-controlled study in patients with cirrhosis and hyperammonemia. Eligible subjects were admitted to an inpatient facility for a run-in diet and 24-hour ammonia profile, and those with an elevated ammonia level proceeded with randomization and received either placebo or orally administered SYNB1020 (5 x 1011 CFU TID) for six days.
Lilly Announced CYRAMZA Met Overall Survival Endpoint
Eli Lilly announced top-line results from its Phase III REACH-2 study of CYRAMZA® (ramucirumab) as a single agent in the second-line treatment of people with hepatocellular carcinoma (HCC), also known as liver cancer. The trial met its primary endpoint of overall survival (OS) as well as the secondary endpoint of progression-free survival (PFS). REACH-2 is a global, randomized, double-blind, placebo-controlled Phase III study of CYRAMZA and best supportive care (BSC) compared to placebo and BSC in hepatocellular carcinoma (HCC) patients who were intolerant to, or that had disease progression while on or following treatment with, sorafenib and had a high alpha-fetoprotein (AFP-High), defined as an AFP of ≥ 400 ng/mL. REACH-2 is the first positive Phase III HCC trial in a biomarker-selected patient population. The REACH-2 study has confirmed the hypothesis generated by the REACH trial results, which showed that a pre-specified subgroup of advanced HCC patients who were AFP-High derived a survival benefit from treatment with CYRAMZA following first-line treatment with sorafenib.
Wize Pharma Enrolls First Patient in Study for Treatment of Dry Eye Syndrome
Wize Pharma announced that it enrolled the first patient in its Phase IV clinical trial in Israel for LO2A in the symptomatic treatment of dry eye syndrome (DES) in patients with Sjögren’s syndrome. This randomized, double-masked study will evaluate LO2A versus Alcon’s Systane Ultra UD, an over-the-counter lubricant eye drop product used to relieve dry and irritated eyes. Approximately 60 patients with Sjögren’s syndrome who are experiencing DES are being randomized in a 1:1 ratio to one of two treatment groups, LO2A or Systane® Ultra UD. Drops will be administered topically to the eye over a three month period. The primary endpoint of the study is the change in corneal/conjunctival staining score using the National Eye Institute (NEI) Industry Grading System after 3 months of study treatment. Secondary endpoints include corneal/conjunctival staining score after one month of treatment and change in Ocular Surface Disease Index (OSDI) score after one and three months of treatment.