June 10 Clinical Quick Takes: Oral semaglutide superior to Jardiance, non-inferior to Victoza; plus Aptinyx and Eli Lilly

Novo’s oral semaglutide meets in Phase III trials
Novo Nordisk A/S (CSE:NOVO B; NYSE:NVO) reported results from two Phase III trials of its oral semaglutide in Type II diabetes. In PIONEER 2, oral semaglutide, a long-acting GLP-1 analog, met the primary endpoint of superiority to Jardiance empagliflozin, an SGLT2 from Boehringer Ingelheim GmbH (Ingelheim, Germany), demonstrating an HbA1c reduction of 1.3% vs. 0.9% (p<0.001) at week 26. In PIONEER 4, the therapy met the primary endpoint of non-inferiority to Novo’s long-acting GLP-1 analog Victoza liraglutide, producing a 26-week HbA1c reduction of 1.2% vs. 1.1%, in patients inadequately controlled by metformin, with or without a SGLT-2 inhibitor.
NYX-2925 alleviates pain in fibromyalgia patients
Aptinyx Inc. (NASDAQ:APTX) announced top-line results from a Phase II study of NYX-2925 in fibromyalgia patients, stating the NMDA receptor modulator met the primary endpoint of reducing brain biomarkers of pain processing. NYX-2925 reduced glutamate/glutamine (Glx) activity in the dorsal anterior cingulate cortex at rest (p<0.05) and in the posterior insular cortex following a pain stimulus (p<0.05), as measured by fMRI. Multiple patient-reported clinical measures also showed statistically significant improvements compared with baseline and placebo.

URLi non-inferiority in management of blood glucose at mealtime
In the Phase III PRONTO-T1D and PRONTO-T2D trials, investigational mealtime insulin formulation ultra rapid lispro (URLi) from Eli Lilly and Co. (NYSE:LLY) showed non-inferior HbA1c reductions at week 26 vs. the pharma’s Humalog insulin lispro, meeting the primary endpoints. The company also observed superior reductions in blood glucose spikes at one hour (-27.9 mg/dL [T1D], -11.8 mg/dL [T2D]) and two hours (-31.2 mg/dL [T1D] and -17.4 mg/dL [T2D]) after a test meal, compared with Humalog. No significant differences in hypoglycemia rates were reported by patients...