Armata Pharmaceuticals, Inc. (NYSE American: ARMP), a US-based biotechnology company, announced on Tuesday that it has dosed its first subject in the Phase 2a portion of the company's diSArm study of AP-SA02 as a potential treatment for Staphylococcus aureus bacteraemia.
The company has commenced the Phase 2a portion of the study subsequent to Data Review Committee (DRC) review of positive safety and tolerability data from the Phase 1b portion.
The diSArm study, a Phase 1b/2a randomised, double-blind, placebo-controlled, multiple ascending dose escalation study, is intended to assess the safety, tolerability, and efficacy of intravenous AP-SA02 as an adjunct to best available antibiotic therapy compared to best available antibiotic therapy alone for the treatment of adults with bacteraemia because of Staphylococcus aureus.
This study is being carried out in two phases, Phase 1b assessed the safety and tolerability of multiple ascending intravenous doses of AP-SA02 or placebo as an adjunct to best available therapy (BAT) compared to BAT alone in subjects with SA bacteraemia (SAB). The Phase 2a is assessing the efficacy, safety, and tolerability of multiple doses of AP-SA02 or placebo as an adjunct to BAT compared to BAT alone in subjects with complicated SAB. The study is to enrol around 50 subjects.
Adcentrx's ADRX-0706 granted US FDA Fast Track designation to treat advanced cervical cancer
Ajinomoto and RIBOMIC announce successful extension of nucleic acid aptamer pharmacokinetics
AstraZeneca secures EU approval for Calquence combo as first-line treatment in mantle cell lymphoma
Odylia Therapeutics undertakes gene replacement therapy project for NPHP1 retinal dystrophy
Phanes Therapeutics doses first patient in peluntamig-atezolizumab combination clinical study
FDA accepts Novo Nordisk's filing application for oral semaglutide 25 mg
Nutshell Therapeutics' NTS071 p53 allosteric reactivator cleared for US clinical trial
Blue Earth Therapeutics initiates Phase 2 trial in metastatic castrate resistant prostate cancer
Armata Pharmaceuticals' AP-SA02 clinical trial receives additional US DoD funding
S&E bio's SNE-101 stroke therapy approved for clinical trial