Amarin Corp. plc, of Dublin, said the independent data monitoring committee has completed its review of the scheduled pre-specified interim efficacy and safety analysis for the REDUCE-IT cardiovascular (CV) outcomes study and has recommended that the trial continue as planned without modification. Because REDUCE-IT is the first prospective trial of any therapy in the large patient population studied, the bars for stopping this trial early for overwhelming efficacy were intentionally set high with the understanding that a more robust result, based on a larger number of CV events, could be obtained by the study continuing to completion, the firm said. Results are expected in the second or third quarter of 2018. The 8,175-patient study is evaluating whether treatment with Vascepa (icosapent ethyl) reduces major adverse CV events in patients who, despite stabilized statin therapy, have elevated triglyceride levels and other cardiovascular risk factors. The drug is an ethyl eicosapentaenoic acid-only omega-3 therapy to reduce triglycerides.

Critical Outcome Technologies Inc., of London, Ontario, said it completed the dose escalation portion of its phase I trial testing COTI-2 in patients with gynecologic cancers who have failed conventional therapy and reported that the drug was generally safe and well-tolerated by patients at doses up to 1.7 mg/kg. Further data from secondary and exploratory endpoints are expected to be available by year-end. The company also said it's starting an expansion arm of the study in patients with head and neck squamous cell carcinoma (HNSCC) at a starting dose of 1 mg/kg to evaluate the safety and tolerability of COTI-2 and to find the recommended phase II dose in patients with HNSCC. Data from that arm of the trial are expected in 2018. Critical Outcomes plans to start expansion arms testing COTI-2 in combination with standard of care chemotherapy and radiation therapy in patients with gynecological malignancies and HNSCC next year.

Evoke Pharma Inc., of Solana Beach, Calif., said it started a comparative exposure pharmacokinetic trial for Gimoti, the company's nasal delivery formulation of metoclopramide. Approximately 100 healthy volunteers will receive Reglan (metoclopramide) tablets and three different doses of Gimoti in a crossover design. Data from the trial is expected in the fourth quarter of this year, and if positive, would result in Evoke filing a 505(b)(2) NDA for Gimoti to relieve symptoms associated with acute and recurrent diabetic gastroparesis in late 2017 or early 2018.

Hemispherx Biopharma Inc., of Philadelphia, reported that Ampligen plus Flumist, known as AMP-600, was well tolerated in 25 healthy human volunteers. Following the data combining Ampligen with Flumist, a seasonal live-virus flu vaccine, Hemispherx plans to collaborate with a vaccine company to test Ampligen intranasally with a non-live virus vaccine.

Omeros Corp., of Seattle, reported additional follow-up data from patients with immunoglobulin A (IgA) nephropathy treated with OMS721 in the phase II trial of glomerulonephropathy. OMS721 is Omeros' lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), the effector enzyme of the lectin pathway of the complement system. As presented in June, patients with IgA nephropathy demonstrated clinically and statistically significant improvement in proteinuria during the course of the clinical trial. After these patients completed the trial, the clinical investigator continued to follow them per standard of care. Follow-up data up to approximately one year after completion of treatment are available. In follow-up, three of the four patients have maintained reductions in proteinuria. In these three patients uACRs remained reduced at 14 percent, 23 percent, and 24 percent of the patients' baseline values prior to OMS721 treatment. Omeros has initiated a phase III program for OMS721 in IgA nephropathy and expects to begin later this year.

Oncoceutics Inc., of Philadelphia, said the first patient has been treated in a phase II trial of ONC201 for patients with recurrent or metastatic neuroendocrine tumors at the Cleveland Clinic. The selection of neuroendocrine tumors for a clinical trial was driven by the discovery in 2016 that ONC201 is a direct antagonist of the D2 dopamine receptor (DRD2). This receptor is highly up-regulated in neuroendocrine cancers. This trial will enroll up to 24 patients with a variety of neuroendocrine tumors, including patients with desmoplastic small round cell tumors and pheochromocytoma-paraganglioma and is designed to measure anti-hypertensive reduction as a secondary endpoint in the PC-PG patients, and may provide an opportunity to demonstrate a clinical benefit in a relatively rapid time frame.

Qu Biologics Inc., of Vancouver, British Columbia, reported positive feedback from the FDA in response to Qu's first pre-IND meeting package submission. The agency gave feedback on product development questions related to manufacturing, clinical trials and non-clinical testing that will guide Qu in its QBECO SSI development program for inflammatory bowel disease, the company said without revealing more details.

Reata Pharmaceuticals Inc., of Irving, Texas, said the FDA confirmed that the modified Friedreich's Ataxia Rating Scale (mFARS) is an acceptable primary endpoint for part 2 of Reata's MOXIe trial testing omaveloxolone in patients with Friedreich's ataxia (FA). The agency recommended that Reata extend the treatment duration for part 2 of the study and add a patient-reported or performance-based outcome endpoint to the study. The FDA indicated that it may consider omaveloxolone for either accelerated or full approval based on the results of the data package. Part 2 of MOXIe will enroll approximately 100 FA patients, measuring mFARS in patients taking omaveloxolone compared to placebo at 48 weeks in addition to other endpoints. Reata plans to start the trial in the second half of this year.

Scynexis Inc., of Jersey City, N.J., reported data from the phase IIa SCY-078-203 trial testing oral SCY-078 in female patients with moderate to severe vulvovaginal candidiasis infections compared to fluconazole at the 2017 Infectious Diseases Society for Obstetrics and Gynecology in Park City, UT. SCY-078, an oral and intravenous triterpenoid antifungal, produced a higher clinical cure rate (78.1 percent) compared to fluconazole (65.6 percent) after 24 days, as well as a lower recurrence rate (4 percent) compared to fluconazole (15 percent) during the four-month follow up period. The company also presented preclinical data showing SCY-078 was potent against vaginal isolates of Candida glabrata and Candida albicansas compared to other antifungals in vitro at acidic pH levels and that SCY-078 concentrated in the vagina of mice.

Spectrum Pharmaceuticals Inc., of Henderson, Nev., said it started a phase III registration trial testing Qapzola (apaziquone) in patients with non-muscle invasive bladder cancer. The trial in 425 patients who have undergone a transurethral resection of the bladder tumor is being conducted under a special protocol assessment agreement with the FDA, measuring time to recurrence of the tumor as the primary endpoint.

Zynerba Pharmaceuticals Inc., of Devon, Pa., reported top-line results from its phase II Synthetic Transdermal Cannabidiol for Treatment of Knee Pain due to Osteoarthritis (STOP) trial testing ZYN002 (cannabidiol gel) in 320 patients with osteoarthritis. The trial didn't meet its primary endpoint of reducing from baseline the weekly mean of the 24-hour average worst pain score at week 12 for either dose. Zynerba noted that the composite responder analysis – defined as at least a 30 percent reduction in worst average daily pain scores and at least a 20 percent improvement in the Western Ontario and McMaster Universities Osteoarthritis physical function score – for the lower 250 mg dose achieved statistical significance and there was a trend toward statistical significance in other secondary endpoints.