Laekna Announces First Patient Dosed in South Korea in LAE201INT2101 Phase 1/2 Study

On September 6, 2022 Laekna, a clinical-stage biotechnology company dedicated to bringing ground-breaking therapies to cancer and liver fibrosis patients worldwide, reported that the first patient recently received a dose in the LAE201INT2101 phase I/II study at Seoul National University Hospital (Press release, Laekna Therapeutics, SEP 6, 2022, View Source [SID1234619112]). The company’s multi-regional clinical trials (MRCTs) now cover China, the United States and South Korea.

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LAE201INT2101 is a multi-center, open-label, phase I/II dose-escalation and efficacy study of the LAE001 and LAE002 (afuresertib) combination in patients with metastatic castration-resistant prostate cancer (mCRPC) with disease progression or intolerability following standard of care (SOC) treatment. Laekna has finished the phase I dose-escalation stage and is starting the phase II stage of the Proof-of-Concept study now.

Metastatic castration-resistant prostate cancer is one of the most intractable cancers. The combination therapy of LAE001 and LAE002 (afuresertib) is expected to provide treatment benefits for patients who progressed after treatments of the new-generation A/AR drugs including abiraterone and enzalutamide. LAE001 inhibits both CYP17A1 and CYP11B2 (aldosterone synthase) as a next-generation anti-androgen inhibitor. LAE002 (afuresertib) is a highly selective AKT kinase inhibitor. Both are the company’s potential core products.

In addition to Seoul National University Hospital, Laekna has already initiated trials in four other clinical sites in South Korea. The study is also ongoing in more than 10 sites across the United States.

"We have been committed to ‘global development and marketing’ since the inception of the company. Based on our clinical team’s strategy and execution capabilities, our trials are now ongoing in more than 90 clinical sites in China, the United States and South Korea," said Dr. Yong Yue, Chief Medical Officer of Laekna. "We are rapidly advancing a number of multi-regional clinical trials to better evaluate the value of our drugs in the treatment of various cancers, and we hope to enable our innovative therapies to benefit more patients worldwide as soon as possible."