Latest New Medical Therapy Trial Results
Following are the most recent results for new drug therapies currently in clinical trials worldwide. Results
are also searchable by therapeutic area beginning with the most recent updates.
Week of January 16, 2017
Agile Therapeutics issued results of a phase III trial of Twirla, a low-dose combined hormonal contraceptive patch. SECURE was a multicenter, single-arm, open-label, 13-cycle trial that evaluated the safety, efficacy and tolerability of Twirla in 2,032 healthy women, aged 18 and over. Of those enrolled, 51.4% of subjects discontinued prematurely from the study and the loss to follow-up rate was 11.3%, which is in line with loss to follow-up rates observed in previous clinical trials of combined hormonal products, and substantially better than the 20% loss to follow-up rate observed in the company’s previous phase III trial. The Pearl Index for the overall intent to treat population of subjects 35 years of age and under was 4.80 with an upper-bound of the 95% confidence interval of 6.06. As with all hormonal contraceptive trials, the number of pregnancies included in Agile’s calculation of the Pearl Index is subject to review by the FDA as part of its overall review of the NDA for Twirla. Consistent with other recent hormonal contraceptive clinical trials, including Ortho Evra and Quartette, and the FDA’s 2015 meta-analysis on the effect of obesity on the effectiveness of hormonal contraceptives, a relationship between obesity and efficacy was observed among subjects 35 years of age and under. Twirla was generally well-tolerated and had an overall favorable safety profile, consistent with publicly available information relating to other low-dose combined hormonal products. The most frequent hormone-related adverse events, none of which were experienced by more than 5% of subjects, were generally in line with those events observed in other low dose combined hormonal products.
Halozyme Therapeutics released results of a phase II study of PEGPH20 in combination with ABRAXANE (nab-paclitaxel) and gemcitabine in stage IV pancreas cancer patients. Stage 2 of the randomized, multicenter study showed a 91% improvement in median PFS for HA-High patients in the PEGPH20 arm, 8.6 months compared to 4.5 months in the control arm and achieved its primary endpoint to evaluate and demonstrate a reduction in the rate of thromboembolic events in the PEGPH20 arm. The company has initiated a phase III clinical trial, HALO 301. HALO 301 is a global, randomized, double-blind, placebo-controlled clinical trial evaluating PEGPH20 for metastatic pancreas cancer. The trial will be conducted at approximately 200 sites with two primary endpoints, progression free survival and overall survival in patients receiving PEGPH20 in combination with gemcitabine and ABRAXANE (nab-paclitaxel) compared to gemcitabine and nab-paclitaxel alone.
Sun Pharma issued results of a phase III trial of Seciera (cyclosporine A, 0.09% ophthalmic solution) for the treatment of dry eye disease. In this 12 week, multicenter, randomized, double-masked, vehicle-controlled confirmatory study, 744 dry eye patients were treated either with Seciera, or its vehicle. After 12 weeks of treatment, as compared to vehicle, Seciera showed statistically significant improvement in the primary end point, Schirmer’s score (a measurement of tear production) (p<0.0001). The demonstration of efficacy by Seciera at 12 weeks is earlier than other drugs approved for dry eye in the same class. Additionally, several key secondary endpoints showed statistically significant improvements compared to vehicle with some showing an even earlier onset of action. Adverse events reported in the trial were mild to moderate in nature and similar to other approved drugs in the category. The company will discuss results with the FDA.
Synthetic Biologics reported results of a phase IIb study of SYN-004 (ribaxamase) designed to protect the gut microbiome from disruption caused by certain intravenous (IV) beta-lactam antibiotics. The study, a randomized, double-blind, placebo controlled trial of 412 patients, met its primary endpoint of significantly reducing C. difficile Infection (CDI). Preliminary analysis of the data indicated seven confirmed cases of CDI in the placebo group compared to two cases in the ribaxamase treatment group. Patients receiving ribaxamase achieved a 71.4% relative risk reduction (p=0.045) in CDI rates compared to patients receiving placebo. Adverse events reported during this trial were comparable between treatment and placebo arms. Preliminary analysis of the data demonstrated a significant reduction in new colonization by vancomycin-resistant enterococci (VRE) for patients receiving ribaxamase compared to placebo (p=0.0002). With agreement from the FDA, the study included a secondary endpoint to assess ribaxamase’s capacity to decrease the incidence of antibiotic-associated diarrhea from all causes. Preliminary analysis of the data suggested a trend toward such a reduction (p=0.13), which was due, for the most part, to the reduction of CDI. Synthetic Biologics is also continuing to prepare for the initiation of pivotal phase IIb/III clinical trials for SYN-010, designed to treat the underlying cause of irritable bowel syndrome with constipation (IBS-C).
Valeant Pharmaceuticals International reported results of a phase III study of IDP-118 (halobetasol propionate and tazarotene) lotion in the treatment of plaque psoriasis. The multicenter, double-blind, randomized, vehicle-controlled clinical study enrolled 203 adult subjects. IDP-118 showed statistical significance (p<0.001) to vehicle with a treatment success rate at eight weeks of 35.76% to 6.98%. The primary endpoint of the 12-week study (eight weeks of treatment followed by four weeks of follow-up) was achievement of a “clear” to “almost clear” score and at least a two grade improvement based on an Investigator Global Assessment (IGA) at eight weeks, and clear to almost clear and at least two grade improvement in the IGA at weeks 12, six, four and two as secondary endpoints.