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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 July 24, 2017

Paratek Pharmaceuticals announced positive top-line results from a pivotal phase III clinical study comparing omadacycline to twice-daily oral linezolid in the treatment of acute bacterial skin and skin structure infections (ABSSSI). The OASIS-2 study was a randomized, double-blind, multicenter study that enrolled 735 adult subjects with moderate to severe ABSSSI at 33 centers in the U.S. The early clinical response (ECR), 48 to 72 hours after the first dose of study drug, for omadacycline was 87.5% compared to 82.5% for linezolid. Omadacycline met statistical non-inferiority compared to linezolid for the EMA-specified co-primary endpoints at the post therapy evaluation, seven to 14 days after completion of therapy in the modified intent-to-treat (mITT) population and the Clinically Evaluable (CE) populations. Clinical success rates at post therapy evaluation in the mITT population for the omadacycline and linezolid arms were 84.2% vs. 80.8%, respectively; and in the CE population were 97.9% vs. 95.5%, respectively. The study met all of its primary and secondary endpoints required to support approval for this indication by the FDA and the EMA.

Spark Therapeutics has published phase III clinical trial data of voretigene neparvovec for the treatment of patients with vision loss due to biallelic RPE65-mediated inherited retinal disease (IRD). In the randomized, controlled gene therapy trial, voretigene neparvovec improved functional vision, light sensitivity and visual field. Results showed a statistically significant and clinically meaningful difference between intervention (n=21) and control participants (n=10) at one year, per the clinical trial’s primary endpoint, mean bilateral multi-luminance mobility testing (MLMT) change score (difference of 1.6; 95% CI, 0.72, 2.41; p=0.0013). Participants maintained functional gains observed 30 days post-administration at the one-year primary endpoint. MLMT evaluates functional vision by documenting the participants’ ability to navigate a mobility course under a variety of specified light levels ranging from one lux (equivalent to, for example, a moonless summer night) to 400 lux (equivalent to, for example, an office environment). In May 2017, Spark Therapeutics completed the rolling submission of a BLA with the FDA.

Theravance Biopharma and Mylan issued results from a 12-month phase III safety study of revefenacin (TD-4208) for the treatment of chronic obstructive pulmonary disease (COPD). The study was a randomized, active-controlled parallel group trial designed to evaluate the safety and tolerability of two doses of revefenacin (88mcg or 175mcg, inhaled once daily via a nebulizer) over a dosing period of 52 weeks, as compared to standard-of-care. Tiotropium (Spiriva), administered via a handheld device, served as the active comparator standard of care treatment arm in the study. Fifty percent of patients in the study were using other COPD therapies, including long-acting beta-agonists (LABA) or LABA/inhaled corticosteroids (ICS). Data from the trial demonstrated low rates of AEs and SAEs for both doses of revefenacin, comparable to tiotropium. Mortality rates were low, balanced across each arm of the study, and deemed by investigators as not related to study treatment. The data will support the submission of the NDA for revefenacin with the FDA, anticipated in the fourth quarter of 2017.

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