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 September 19, 2016
Foamix Pharmaceuticals issued results of a phase II trial of FMX103 for papulopustular rosacea. The double-blind, randomized, placebo-controlled trial included 233 subjects with moderate-to-severe rosacea. Subjects were randomized to receive either one of two doses of FMX103 minocycline foam (3% or 1.5%) or vehicle foam once daily over 12 weeks, followed up by a four-week post-treatment evaluation. The efficacy endpoints were the absolute change in the number of inflammatory lesions papules and pustules and improvement of the Investigator Global Assessment of severity (IGA). At week 12, the 1.5% and 3% doses of FMX103 both significantly reduced the number of papules and pustules vs. the vehicle (1.5% and 3%, both p<0.001, ANCOVA, intent-to-treat analysis). The mean reduction in lesion count of each treatment group vs. its baseline was 21.1 for the 1.5% dose, 19.9 for the 3% dose and 7.8 for vehicle; the corresponding percent reductions were 61.4% and 55.5% for the FMX103 1.5% and 3% groups, respectively, and 29.7% for the vehicle. Both the 1.5% and 3% doses of FMX-103 were significantly better compared to vehicle in reducing the IGA score by two grades and in reaching a “clear” (score=0) or “almost clear” (score=1) rating at week 12 (p<0.01 and p<0.05, respectively, CochranMantelHaenszel test). Both the 1.5% and 3% doses were efficacious and there was no statistically significant difference between doses. FMX103 appeared to be generally safe and well-tolerated. There were no serious treatment-related AEs and few subjects overall reported any treatment-related AEs (two, four and five in the 1.5%, 3% and vehicle groups, respectively).
Genentech reported results of three OCREVUS (ocrelizumab) phase III studies in relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). Data showed that OCREVUS significantly increased the proportion of RMS patients achieving No Evidence of Disease Activity (NEDA) by 75% compared with interferon beta-1a over 96 weeks (0-96 weeks, p<0.0001). Additionally, compared with interferon beta-1a, OCREVUS treatment significantly increased the relative proportion of patients achieving NEDA by 33% in weeks 0-24 and by 72% in weeks 24-96 (both p<0.0001). A majority of patients achieved NEDA in the first 24 weeks of OCREVUS treatment (60.8%) and this proportion increased during weeks 24-96 of the study (72.2%). Patients who achieved No Evidence of Progression (NEP) had no evidence of confirmed disability progression sustained for at least 12 weeks and less than 20% worsening of performance on the timed 25-foot walk and nine-hole peg test. OCREVUS treatment significantly increased the proportion of PPMS patients with NEP by 47% at week 120 compared with placebo (p=0.0006).
Repros Therapeutics released results of a phase II study of Proellex for the treatment of premenopausal women with confirmed symptomatic endometriosis. The study was a double-blind study with endometriosis defined as a baseline BBSS Score (Biberoglu and Behrman Symptom Score) of seven or greater. Subjects were randomized to 6mg or 12mg of Proellex or placebo in a 1:1:1 fashion. The study randomized 60 subjects at a mean age of 30 years. The median percentage change from baseline in the patient BBSS assessment of menstrual pain showed that subjects improved with an 85.4% reduction in baseline score (p<0.0001). In addition, despite evidence of a placebo response, subjects treated with Proellex had a statistically significant greater reduction in menstrual pain compared to the 37.5% change from baseline achieved with placebo (p=0.0008). During this first course of treatment, subjects treated with Proellex experienced a 56% reduction in total pill count while placebo-treated subjects’ pill use declined by 30% (p=0.0521). The reduction in non-prescription use was significant: Proellex-treated subjects had a 74% reduction while placebo-treated subjects only experienced a reduction of 11% (p=0.0423). The company intends to discuss phase III trials with the FDA.
RespireRx Pharmaceuticals reported results of a phase IIa study of CX1739 for the respiratory depressive effects of remifentanil (REMI) and acute opioid overdose and chronic opioid use. The trial was conducted in two separate stages over a four week period. Stage 1, a randomized, double-blind, crossover study comparing 300mg of CX1739 to placebo, was considered a primary outcome study. Acute bolus injection of REMI caused a rapid and dramatic decline in respiration, with Emax ranging from 15% to 100% across subjects. When subjects in Stage 1 were pre-treated with 300mg of CX1739, a statistically significant reduction of recovery time (RT) was observed. RT was reduced from a mean of 6.8+/-0.98 after placebo pre-treatment to a mean of 4.4+/-0.77 after 300mg of CX1739 pre-treatment (p=0.01, paired t test). In Stage 2, RT was reduced for both doses, although no significant differences (p>0.05) were observed when these doses were compared to either placebo or 300mg. While this difference between 300mg and the higher doses might reflect greater efficacy at the 300mg dose, the company believes that this lack of significance for the higher doses might also reflect inter-subject variability in what doses produced the optimum decline in RT. Supporting this idea, responder analysis revealed that decreases in RT were observed, in a statistically significant proportion of subjects (13 out of 15, p<0.005, z test), after one or more doses of CX1739. Using these data from optimum doses, mean RT was significantly (p<0.002, paired t test) reduced from 6.8 +0.98 minutes after placebo to 3.7 +0.70 minutes after CX1739. Future studies are being designed and planned.