Zenas BioPharma Reports Positive Phase 3 Obexelimab Trial Data
Zenas BioPharma, Inc. (ZBIO) presented new Phase 3 trial data for its experimental drug obexelimab. Results from the study showed that patients receiving the treatment achieved a 93% probability of remaining flare-free over 12 months based on adjudicated assessments, while investigator estimates showed an 87% rate.
The trial findings indicate sustained treatment effect alongside reduced dependence on steroids. Patients experienced significantly lower cumulative steroid toxicity at week 52 compared to placebo. Additionally, safety findings remained favorable, with adverse event rates during the open-label extension matching or falling below those observed in the initial randomized phase. A sub-study also demonstrated positive immune responses to influenza and COVID-19 vaccines during treatment pauses.
Investors and medical researchers will keep an eye on further clinical updates and potential regulatory submissions for obexelimab as long-term safety data continues to accumulate. Meanwhile, shares of the biotechnology company slipped 3.15% to $26.40 in recent trading.
Key points
- Zenas BioPharma, Inc. (ZBIO) reported a 93% 12-month flare-free rate by adjudicated measures in its Phase 3 obexelimab trial.
- Obexelimab significantly reduced cumulative steroid toxicity compared to placebo at week 52.
- Adverse event rates in the open-label extension were at or below rates seen during the randomized treatment period.
- A vaccine sub-study showed seroimmunity rates of 86% for flu and 100% for COVID-19 following a brief treatment window.
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What were the Phase 3 trial results for Zenas BioPharma obexelimab?
The Phase 3 trial showed a 93% probability of patients remaining flare-free over 12 months based on adjudicated data, along with reduced steroid toxicity compared to placebo.
How did obexelimab affect steroid toxicity and safety?
Obexelimab significantly decreased cumulative glucocorticoid toxicity at week 52 versus placebo, and adverse event rates in the extension study were comparable to or lower than the randomized period.
How did ZBIO stock react to the obexelimab data?
Shares of Zenas BioPharma, Inc. (ZBIO) traded down 3.15% to $26.40 following the release of the trial results.