On October 19, 2018 Laekna Therapeutics reported that its Investigational New Drug (IND) application for LAE001 was officially accepted by Center for Drug Evaluation (CDE), China Food and Drug Administration (Press release, Laekna Therapeutics, OCT 19, 2018, View Source;article_id=42 [SID1234530434]).
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LAE001 is a novel, non-steroid, potent reversible dual inhibitor of Cytochrome P450 (CYP) 17A1 and CYP11B2. It will be mainly used as the treatment for metastatic prostate cancer.
Prostate cancer is one of the most common malignancies in men, and it is the second most common cause of cancer-related mortality (after lung cancer). In China, prostate cancer is the only one among the top ten cancers with yearly increased both the incidence rate and mortality rate. In most European and north America countries, the metastasis prostate cancer accounts only 15% of all prostate cancer. However, more than 50% of Chinese patients with prostate cancer had metastasis status at the time of diagnosis. Comparing to the current treatments for prostate cancer, LAE001 has demonstrated robust therapeutic efficacy and better safety profile in US phase I clinical trial. Due to its dual mechanism of inhibition of two critical enzymes for testosterone and aldosterone synthesis, LAE001 does not affect the levels of mineralocorticoid in men, and therefore reduces the risk of hyperaldosteronism and hepatotoxicity. LAE001 can also be used as a monotherapy without prednisone. It is expected that LAE001 will provide a better treatment option for the patients with prostate cancer after it is launched.