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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 August 14, 2017

Allegro Ophthalmics issued results of a phase IIb study of Luminate for treatment of diabetic macular edema (DME). The study evaluated Luminate as a sequential therapy or in combination therapy with anti-VEGF in 80 patients with DME. The primary endpoint of the DEL MAR phase II Stage 2 study was non-inferiority to bevacizumab in mean change in best-corrected visual acuity (BCVA) at 20 weeks when Luminate was used with a single bevacizumab pre-treatment (sequential therapy) or in combination with bevacizumab. The Luminate results were achieved after one treatment of 1.25mg bevacizumab (week zero) followed by three 1mg Luminate injections (weeks one, four and eight) and 12 weeks off treatment, compared to five injections given every four weeks with bevacizumab. The data showed the mean gain in BCVA was 7.1 letters for patients in the Luminate with bevacizumab pre-treatment (sequential) group compared to 6.7 letters for patients in the bevacizumab control group. The double masked, placebo-controlled, randomized, multicenter, five-month trial included five arms. The trial also found that Luminate was well-tolerated with no drug toxicity or intraocular inflammation. These safety results are consistent with previously conducted Luminate studies on human subjects where there were no reports of significant inflammation, and no evidence of retinal tears or detachments.

FibroGen reported results of a randomized, double-blind, placebo-controlled phase II study and two combination safety sub-studies of pamrevlumab for treatment of idiopathic pulmonary fibrosis (IPF). In the double-blind, placebo-controlled portion of this study, 103 patients were randomized (1:1) to receive either pamrevlumab or placebo for 48 weeks. Pamrevlumab met the primary efficacy endpoint of change of forced vital capacity percent predicted (FVC % predicted), a measure of change in lung volume, from baseline to week 48 of the study. Statistical significance was demonstrated using a linear slope analysis in the intent to treat population. Average decline in FVC % predicted from baseline to week 48 was 2.85 in the pamrevlumab arm as compared to an average decline of 7.17 in the placebo arm, an absolute difference of 4.33. Pamrevlumab-treated patients had an average decrease in FVC of 129ml at week 48 compared to an average decrease of 308ml in patients receiving placebo. Consistent with previous clinical studies, pamrevlumab was well-tolerated in IPF patients. In the double-blind, active-controlled combination sub-studies, 57 patients were randomized to assess the safety of combining pamrevlumab with approved IPF therapies. Thirty-six patients on a stable dose of pirfenidone were randomized 2:1 to also receive pamrevlumab or placebo for 24 weeks. Twenty-one patients on a stable dose of nintedanib were randomized 2:1 to also receive pamrevlumab or placebo for 24 weeks. Pamrevlumab was well tolerated when administered in combination with either pirfenidone or nintedanib. The company anticipates meeting with the U.S. FDA to address the clinical and regulatory path forward for pamrevlumab in this indication.

Gemphire Therapeutics released results of a phase IIb, double-blind, placebo-controlled, randomized study of oral gemcabene 600mg dosed once daily in hypercholesterolemic patients. ROYAL-1 enrolled patients who were not adequately controlled, with an existing LDL-C value ≥100mg/dL (2.59mmol/L) and a TG value < 500mg/dL (5.65 mmol/L), on stable high- or moderate-intensity statin and/or ezetimibe therapy. Patients were stratified according to background statin intensity and diabetes status. One hundred and five subjects were enrolled at sites in the U.S. and randomized to either gemcabene 600mg or placebo for a total of 12 weeks. The primary endpoint was the percent change in LDL-C from baseline. Secondary endpoints included safety as well as the percent change from baseline in non-HDL-C, TC, TG, HDL-C, VLDL-C, Apo B, hsCRP and several other biomarkers. Fifty-six females and 49 males with a mean age of 61 years were enrolled. The mean baseline LDL-C was 130mg/dL. Gemcabene 600mg produced a mean percent change in LDL-C of -17.2% vs -5.5% for placebo (ANCOVA: p=0.0057). Gemcabene 600mg produced a median percent change in hsCRP of -40.0% (ranked ANCOVA: p<0.0001) vs -6.1% for placebo. Additional secondary results and subpopulations assessments will be provided once the full dataset has been analyzed. There were no serious adverse events in the study.

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