sofnobrutinib (AS-0871) / Carna Biosci - LARVOL DELTA

Safety, pharmacokinetics, and pharmacodynamics of sofnobrutinib, a novel non-covalent BTK inhibitor, in healthy subjects: First-in-human phase I study. (PubMed, Clin Transl Sci) - "Similarly, IC50 for B-cell activation was 187.21 ng/mL. These data support further investigation of sofnobrutinib in allergic and autoimmune diseases."

Clinical • Journal • P1 data • PK/PD data • Immunology

Regarding the results of the MAD part of the phase 1 clinical trial of the BTK inhibitor sofnobrutinib (AS-0871) [Google translation] (Nikkei) - P1 | N=NA | "The clinical trial report containing the results has been finalized. The outline is as follows....Most adverse events are mild; No dose-dependent increasing trend was observed in the frequency and severity of adverse events. Favorable pharmacokinetic profile with dose-dependent increase in blood drug concentration; In sofnobrutinib 150 mg BID and 300 mg BID treatment groups, basophils, an indicator of pharmacodynamic effect, Strongly inhibits activation (more than 90%)..."

P1 data • Immunology

Carna Bioscience Announces Initiation of Phase 1 Clinical Trial MAD Part of BTK Inhibitor AS-0871 [Google translation] (Nikkei) - "We are pleased to announce that AS-0871, an in-development BTK inhibitor, has started to be administered to subjects in the MAD part of the Phase 1 multiple dose escalation (MAD) study."

Trial status • Immunology • Inflammation

Carna Biosciences Announces Completion of Phase 1 Clinical Trial BA Part Using Tablet Formulation of BTK Inhibitor AS-0871 [Google translation] (Nikkei) - "We are pleased to announce that we have completed administration of the BTK inhibitor AS-0871, which we are developing, in the bioavailability (BA) part of the phase 1 clinical multiple dose escalation (MAD) trial using a tablet formulation."

Trial status • Immunology • Inflammation