Phase 1 Safety, Tolerability, and Pharmacokinetics of SPR720

This was a single-center, phase I, randomized, double-blind, placebo-controlled, first-in-man study. 96 healthy volunteers were enrolled in this 2-part, multi-cohort study. In both Part 1 and Part 2, sequential cohorts were exposed to increasing doses of SPR720. A total of 96 healthy volunteers (n = 8/cohort, 3:1 randomization) received SPR720 (or placebo) as single oral doses ranging from 100 to 2,000 mg or repeat total daily doses ranging from 500 to 1,500 mg for 7 or 14 days. SPR720 was well tolerated at daily doses of up to 1,000 mg for up to 14 days.

BTZ-043 Multiple Ascending Dose / EBA

PanACEA-BTZ-043-02 was an adaptive seamless phase 1b/2a study performed at two South African sites. In phase 1b, doses were escalated by increments of 250mg with pre-specified decision-rules for seamless transition; in phase 2a, patients were randomised to receive one of three different doses BTZ-043, or standard treatment. Bacterial killing was assessed in liquid culture from overnight pooled sputum samples. Food effect on BTZ-043 exposure was assessed in phase 1b, drug-drug-interaction potential by a probe drug cocktail or dolutegravir in phase 2a.

OPC-167832 Phase 1 / 2 EBA

A phase I study in healthy adults was conducted to assess the pharmacokinetic, safety, and tolerability profiles of single ascending doses of OPC-167832, as well as the effects of food on its absorption, distribution, and elimination. This phase I study was followed by a phase I/IIa study, in which adult participants with drug-susceptible pulmonary TB were treated for 14 days with ascending doses of OPC-167832 monotherapy.

Spero Therapeutics Announces Collaboration with GMRI to Develop SPR720 for TB

-- Globe Newswire reported on June 20th -- Spero Therapeutics, Inc., a multi-asset clinical-stage biopharmaceutical company focused on identifying, developing and commercializing treatments in high unmet need areas involving multi-drug resistant (MDR) bacterial infections and rare diseases, today announced that it entered into a collaboration with the Bill & Melinda Gates Medical Research Institute (Gates MRI) to develop SPR720 for the treatment of lung infections caused by Mycobacterium t

Bill & Melinda Gates Medical Research Institute

The Bill & Melinda Gates Medical Research Institute (Gates MRI) is a non-profit biotechnology development organization focused on reducing or eliminating vexing diseases in global health. The Gates MRI’s mission is to develop products to prevent and/or treat tuberculosis, malaria, enteric infections and maternal, neonatal and childhood diseases, all of which are major causes of mortality and inequality in Low-Middle Income Countries (LMIC).

Pages

Subscribe to Working Group for New TB Drugs RSS