Atriva Therapeutics GmbH has announced the successful conclusion and top-line results of its Phase I clinical trial for its lead antiviral drug candidate ATR-002.
ATR-002 is a first-in-class MEK inhibitor of viral replication, targeting a fundamental host-cellular protein in the replication pathway of influenza-causing viruses. MEK inhibitors have shown high potential as efficacious antiviral drugs, which address the need for a novel, broadly active, resistance-avoiding influenza therapy. Potential advantages of this host-targeting approach are the prolonged treatment window and the reduced potential of viral resistance, both compared to therapies that directly target viral structures.
The randomized, double blind, placebo-controlled dose escalation study (EudraCT 2019-000784-25), conducted in Belgium, demonstrated the safety and tolerability of ATR-002 in 70 healthy volunteers. It followed an adaptive design with a starting dose of 100 mg and up to three escalation steps in seven arms, following a single ascending dose / multiple ascending dose (SAD / MAD) regime. Administration scheme was one dose ATR-002, escalating 100 mg to 900 mg (SAD), followed by seven doses ATR-002, escalating 100 mg to 600 mg QD over seven days (MAD). Each dose cohort was considered to be safe by the Safety Review Committee (SRC), with release allowed for the next higher dose (up to SAD 900 mg and MAD 600 mg, respectively). The observed pharmacokinetic profile supports the intended once-daily regime for the further Phase II clinical development.
The official report will be released in January 2020.