The Phase 1 study, a non-randomised, open-label, multicentre trial, is evaluating IKS014 in patients with locally advanced or metastatic solid tumours expressing HER2
The therapy was well tolerated through Week 24, with a safety profile consistent with Alumis’ Phase 2 data
Despite some promising subgroup signals, the company indicated it will not pursue further psychiatric trials
The therapy also drove additional weight loss at the higher 1.8 mg dose without plateauing and maintained a favorable tolerability profile
The study found BIC/LEN to be statistically non-inferior to BIKTARVY, Gilead’s current standard-of-care therapy
The trial met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival
At one year, the drug met its primary and all key secondary endpoints, delivering significantly better weight maintenance than placebo
The combination also outperformed chemotherapy on another important secondary endpoint
The randomized, double-blind, placebo-controlled single ascending dose (SAD) study evaluated safety, tolerability, pharmacokinetics, and target engagement in 46 healthy participants
Retatrutide, tested at 9 mg and 12 mg doses alongside diet and exercise, met all primary and key secondary endpoints
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