Laekna Therapeutics Shanghai Co., Ltd, a biopharmaceutical company based in China, has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a Phase III clinical study for its drug combination LAE001 and LAE002 (afuresertib) in patients with metastatic castration-resistant prostate cancer (mCRPC) who have received standard treatment.
Both LAE001, an aldosterone synthase inhibitor targeting CYP17A1 and CYP11B2, and LAE002, a highly selective AKT kinase inhibitor, were in-licensed from the Swiss pharmaceutical giant Novartis. This drug pairing has previously initiated 10 global multi-center Phase II clinical studies in the US and South Korea for patients with mCRPC following standard treatment.
As of November 21, 2023, the median radiographic progression-free survival (rPFS) for 40 enrolled patients under the recommended Phase II dose was 8.1 months, a significant improvement over the 2 to 4 months median rPFS typically observed in mCRPC patients under previous standard treatments. The combination therapy has demonstrated a favorable safety profile, with adverse events being generally well-tolerated and manageable.- Flcube.com
