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 November 23, 2015

AcelRx Pharmaceuticals has released results in a phase III study of Zalviso (sufentanil sublingual tablet system 15mcg) for the treatment of faster onset of pain relief in obese (BMI 30kg/m2) post-surgical patients. Patients who self-administered Zalviso experienced statistically significantly improved pain relief when compared to self-administered IV morphine as measured by pain intensity difference to baseline (PID). Significant differences in PID were observed as early as 45 minutes after the first dose (p<0.05), a trend that continued until six hours after the initial dose (p<0.001), after which time PID scores equilibrated between the two groups. Results of the subgroup analysis presented by AcelRx also show that obese patients who administered Zalviso experienced statistically fewer adverse events than did those receiving intravenous patient-controlled analgesia morphine. While overall adverse event rates were comparable, incidence rates of anemia, leukocytosis (increase in white blood cells), vomiting, hypoalbuminemia (decrease in albumin levels), hyponatremia (decrease in sodium levels), urinary retention and pruritus (itching) were all significantly lower in the Zalviso arm compared to the morphine arm (p≤0.05).

MicuRx Pharmaceuticals has reported results of a phase II study of MRX-I for the treatment of drug-resistant bacteria such as MRSA and VRE. The double-blind study conducted at six sites in the U.S. enrolled a total of 120 patients with acute bacterial skin and skin structure infections (ABSSSI), each of whom received 10 days of treatment consisting of twice-daily oral administration of either 800mg of MRX-I (n=80 subjects) or linezolid (n=40). For the primary efficacy end point, 90% of patients (72/80) in the MRX-I group achieved early clinical response, compared to 87.5% of patients (35/40) in the linezolid group. MRX-I demonstrated a favorable safety and tolerability profile. No drug-related serious adverse events or discontinuation of the treatment due to adverse events were noted in MRX-I patients. The positive results are in line with those of the first phase II clinical study in complicated skin and soft tissue infections performed by MicuRx in China.

Regeneron Pharmaceuticals and Sanofi have announced results from a pivotal phase III study of sarilumab for treatment of rheumatoid arthritis (RA). The SARIL-RA-TARGET trial enrolled 546 RA patients who were inadequate responders or intolerant of TNF-alpha inhibitors (TNF-IR). Patients were randomized to one of three treatment groups self-administered subcutaneously every other week: sarilumab 200 milligrams (mg), sarilumab 150mg, or placebo, in addition to non-biologic disease modifying anti-rheumatic drugs (DMARD) therapy. The change from baseline to week 12 in Health Assessment Questionnaire-Disability Index (HAQ-DI) was -0.49, -0.50, and -0.29 in the sarilumab 200mg (p=0.0004), sarilumab 150mg (p=0.0007), and placebo groups, respectively. Improvements in signs and symptoms of RA at week 24, as measured by the proportion of patients achieving an ACR20 response (ACR20) were 61% in the sarilumab 200mg group; 56% in the sarilumab 150mg group; and 34% in the placebo group, all in combination with DMARD therapy (p<0.0001). Proportion of patients achieving an ACR50 response at week 24 were 41% in the sarilumab 200mg group, 37% in the sarilumab 150mg group, and 18% in the placebo group (p<0.0001). Treatment-emergent adverse events (TEAEs) were more frequent in the sarilumab groups (65% and 66% in sarilumab 200mg and 150mg v. 50% in placebo, respectively). The incidence of serious adverse events (SAEs) was higher than placebo in the sarilumab 200mg group (5% v. 3%) and was similar to placebo in the 150mg group (3%). Infection was the most frequently reported adverse event (30%, 22% and 27% in the 200mg, 150mg and placebo groups, respectively). Sanofi and Regeneron recently submitted a BLA for sarilumab to the FDA. 

ZS Pharma has issued interim results of a global, multicenter, phase III trial of ZS-9 (sodium zirconium cyclosilicate) for hyperkalemia. The trial investigated the long-term safety and efficacy of ZS-9 in 750 patients with hyperkalemia (potassium levels >5mEq/L) from sites in the U.S., E.U., Australia and South Africa. Patients with hyperkalemia receive a 10-gram dose of ZS-9 administered three times daily for until achieving normokalemia during the 24- to 72-hour acute phase of the study. Patients that achieve normokalemia then receive a 5-gram dose of ZS-9 administered once-daily with the ability to titrate dose in 5-gram increments or decrements, if needed, to maintain normokalemia. The primary endpoint is safety and tolerability, and the secondary endpoint is the proportion of patients with average serum potassium =5.1 mEq/L between month three and month 12. Ninety-nine percent of patients achieved normokalemia in the acute phase on 10 grams TID of ZS-9. Mean potassium levels were maintained at 4.6mEq/L throughout the 12-month, long-term treatment phase. The primary efficacy endpoint was met with 87% to 92% of patients maintained at an average serum potassium =5.1mEq/L between month three and month 12. Normokalemia was maintained with patients receiving once-daily 5-gram (64%), 10-gram (30%) or 15-gram (5%) doses of ZS-9. There were no deaths in the acute phase; five deaths (0.7%) occurred in the long-term phase, but none were considered to be related to the study drug.