V-5 Immunitor: Interim Phase IIb data

Interim data from 55 evaluable patients in the double-blind, Ukrainian Phase IIb Study imm01 trial showed that once-daily oral V5 plus standard of care (SOC) met the primary endpoint of a significantly greater proportion of patients with a negative sputum smear at 1 month vs. placebo plus SOC. Specifically, 26 of 27 patients (96.3%) treated with V5 plus SOC had a negative sputum smear compared to 7 of 28 patients (25%) who received placebo plus SOC. On secondary endpoints, the average weight gain in all V5-treated patients was 3.4 kg compared to 1.07 kg for the 19 placebo-treated patients who gained weight. Additionally, V5 eliminated TB-associated fever in 100% of patients vs. 39.3% for placebo. SOC consisted of ethambutol, isoniazid, rifampicin, streptomycin and pyrazinamide. Immunitor completed enrollment of 120 patients in the trial in November. Data were published in the Journal of Immunotherapy. ...