New Drug Update for The Week Ending June 29

Regulatory Update

In June 2019, the FDA rejected Acer Therapeutics’ celiprolol (Edsivo) for the treatment of Ehlers-Danlos syndrome and requested a new clinical trial be completed.

Nabriva announced the EMA accepted the MAA for lefamulin in June 2019 for treating community-acquired pneumonia.

Aimmune submitted an MAA for AR101 to the EMA in June 2019. AR101 is Aimmune’s Oral Immunotherapy used to desensitize the patient with peanut allergy.

Announced Research Updates

Conatus announced that in the 48-week, 217 patient, Phase IIb, ENCORE-LF trial, emricasan did not improve a composite endpoint of all-cause mortality, new decompensation events, or ≥4 points progression in the MELD score compared to placebo in NASH patients with compensated or early decompensated liver cirrhosis and severe portal hypertension. As in the original ENCORE-PF trial, there was no improvement in the hepatic venous pressure gradient after an additional 24 weeks of treatment with emricasan.

Proxel announced that in the 16-week, 215 patient, Phase III, TIMES 3 trial, imeglimin in combination with insulin decreased HbA1c 0.6% in Japanese patients with type 2 diabetes

Published Research Updates

In a 12-week, 616 patient Phase IIb, dose ranging trail trial, more patients treated with Alder Biopharmaceuticals’ eptinezumab 300 mg achieved a 75% or > decease in migraine days compared to placebo (33.1% vs 20.7%), but there was no difference with 100mg, 30mg and 10 mg in patients with chronic migraine. 

In the 255 patient, Phase III ADMYRE trial, PharmaMar’s plitidepsin plus dexamethasone did not improve progression free survival or overall survival compared to dexamethasone monotherapy in patients with multiple myeloma.

A lasmiditan safety analysis of 4,439 patients that participated in the Phase III SPARTAN and SAMURAI trials focused on dizziness and found that dizziness increased with dose was mostly mild or moderate in severity. Dizziness did not affect efficacy. The occurrence was 8.6% with 50 mg, 14.9% with 100 mg and 16.8% with 200 mg compared to 2.9% with placebo. The median time to onset was 30-40 minutes, with a median duration of 1.5-2 hours. Besides dose, risk factors for dizziness were non-Hispanic/Latino, mild or moderate severity of migraine attack, and lower body mass index.

In a 12-week, 365 patient, Phase II trial, treatment with Daiichi Sankyo/Exelixis’ esaxerenone 1.25 mg, 2.5 mg, and 5 mg reduced urinary albumin-to-creatinine ratio 38%, 50%, and 56% compared with 7% with placebo in Japanese patients with type 2 diabetes mellitus and microalbuminuria. 

In a 12-week, 363 patient, Phase IIb trial, 8.6% of patients treated with Cassiopea’s clascoterone, 1% and 8.3% of patients treated with clascoterone 0.1% had at least a two-grade improvement and achieved a clear or almost clear score with the Investigator’s Global Assessment in patients with facial acne.