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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 June 27, 2016

Acucela, a clinical-stage ophthalmology company that specializes in identifying and developing novel therapeutics to treat and slow the progression of sight-threatening ophthalmic diseases, announced today top-line results from the phase IIb/III clinical trial (S.E.A.T.T.L.E. study) of the investigational visual cycle modulator emixustat hydrochloride (emixustat). “We are carefully reviewing the data in geographic atrophy before we decide on our next steps with emixustat in this indication. We will continue to advance our in-licensed projects as well as our in-house research.” The study enrolled 508 patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The study did not meet its primary endpoint with none of the treatment groups showing a significant difference in lesion growth rate from placebo. The lesion growth rates over 24 months for the 10mg, 5mg, 2.5mg and placebo groups were 1.84 mm2/year, 1.83 mm2/year, 1.69 mm2/year, 1.69 mm2/year, respectively. There was no significant difference in the mean change of best corrected visual acuity from baseline to month 24 between treatment groups. There was a small numerical treatment difference observed in certain patients with specific genetic profiles in favor of emixustat.

Allergan and Gedeon Richter announced positive results from Venus I, one of two pivotal phase III clinical trials evaluating the efficacy and safety of ulipristal acetate in women with uterine fibroids. The study included 157 patients, with 101 patients randomized to ulipristal acetate 5 and 10mg and 56 to placebo. The study met all the co-primary and secondary endpoints with both ulipristal treatment arms achieving statistically significant results over placebo (p<0.0001). The co-primary efficacy endpoints were the percentage of patients with absence of uterine bleeding and time to absence of uterine bleeding. Significantly more patients in the 10 mg group (58.3%; p<0.0001) and the 5mg group (47.2%; p<0.0001) achieved absence of bleeding compared to placebo (1.8%). There were no treatment-related serious adverse events. No patients discontinued ulipristal acetate treatment due to adverse events. The most common adverse events (5%) on ulipristal acetate treatment were hypertension (N=6), blood creatine phosphokinase increased (N=5), hot flush (N=5), and acne (N=3). Venus I is the first clinical trial to report topline results. The second of two clinical trials, Venus II is anticipated to be completed this year with topline results expected in the first half of 2017. A new drug application for the treatment of uterine fibroids is planned to be submitted in 2017. 

Novo Nordisk is reporting that new phase IIIa findings showed that faster-acting insulin aspart demonstrated a statistically significant reduction in HbA1c in type 1 diabetes, compared with NovoLog (insulin aspart [rDNA origin] injection), a comparable HbA1c reduction in type 2 diabetes versus NovoLog and improved post-meal or postprandial glucose (PPG) control in type 1 and type 2 diabetes. Results from the onset 1 and onset 2 treat-to-target trials comparing faster-acting insulin aspart with NovoLog were presented at the 76th annual Scientific Sessions of the American Diabetes Association (ADA) in New Orleans, LA. In onset 1, after 26 weeks of randomised therapy, faster-acting insulin aspart showed statistically significantly greater HbA1c reduction versus NovoLog in adults with type 1 diabetes when dosed at mealtime ([95% confidence interval (CI)] -0.15 [-0.23; -0.07]). Faster-acting insulin aspart also showed comparable HbA1c reduction when dosed 20 minutes after starting a meal, compared with NovoLog dosed at mealtime ([95% CI] 0.04 [-0.04; 0.12]).[1] Trial results for onset 1 also showed superior reduction in 2-hour PPG increment ([95% CI] -0.67 [-1.29; -0.04] mmol/L) versus NovoLog. The change in 1-hour PPG increment, a secondary supportive endpoint, was also reduced ([95% CI] -1.18 [-1.65; -0.71] mmol/L). In onset 2, faster-acting insulin aspart demonstrated non-inferiority in HbA1c reduction compared with NovoLog® ([95% CI] -0.02 [-0.15; 0.10]) in adults with type 2 diabetes. Trial results could not confirm a statistically significant reduction in 2-hour PPG increment ([95% CI] -0.36 [-0.81; 0.08] mmol/L). However, a statistically significant reduction in 1-hour PPG increment was shown with faster-acting insulin aspart ([95% CI] -0.59 [-1.09; -0.09] mmol/L)[2] which was a secondary supportive endpoint.

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