Foresee Pharmaceuticals announced the top-line result of FP-001 LMIS (Leuprolide Mesylate Injectable Suspension) 50mg phase III clinical trial, an open-label, single-arm study in subjects with Advanced Prostate Carcinoma. The primary efficacy end point was achieved in 97% of subjects.
The primary efficacy end point is the percentage of subjects with suppression of serum testosterone (50ng/dl) by day 28 and from day 28 to day 336 in the intent-to-treat (ITT) population. The targeted efficacy was that the lower limit of the 2-sided 95% confidence interval (CI) for suppression is to be >90%.
In this study, 137 subjects were enrolled and received a minimum of one dose of the study drug (ITT population), and 124 subjects completed the study without major protocol violations that would affect the primary efficacy endpoint (per-protocol population (PP)). The 95% CI from Kaplan-Meier estimates was (92.2%, 98.9%), and the 95% repeated-confidence interval was (92.5%, 99.4%). By day 28, mean testosterone concentration was suppressed below castrate levels to 17.6 ng/dL, and the suppression rate was 98.5% (135 out of 137 subjects achieved medical castration). No mean increase in testosterone was observed after the second injection. Four subjects did not achieve successful suppression of testosterone by the primary efficacy end point analysis, two of which failed to achieve castration level on day 28 and the other two had transient testosterone escapes.
The most common adverse events reported in this study include "hot flushing" (48.9%), followed by "hypertension" (14.6%), "injection site pain" (7.3%), "fatigue" (6.6%), etc., most in mild or moderate intensity. Overall, treatment with LMIS 50 mg injection every 6 months was safe and well tolerated. These safety data are similar to those of marketed LH-RH agonists in the same patient population.
"We are excited about the successful top-line results of FP-001 LMIS, a program in which we have invested many years of internal R&D efforts," said Dr. Ben Chien, chairman and CEO of Foresee. "Our Stabilized Injectable Formulation platform technology overcomes the technical barriers that our competitors have had over the years in generating a stable, premixed, prefilled version of leuprolide depot for injection. FP-001 offers prostate cancer patients a comfortable and convenient solution and facilitates the preparation and drug administration process for the healthcare specialists. Based on its differentiated profile, we are confident that FP-001 LMIS will successfully penetrate the fast growing global prostate cancer market of $7.5 billion via key strategic collaborations such as a commercial partnership in the U.S. and out-licensing in other key territories such as Europe, Japan, China and emerging markets."
"In our first-in-class NCE pipelines, FP-025, a highly selective oral MMP-12 inhibitor targeting inflammatory and fibrotic diseases, is currently completing a phase I study in Asthma/COPD, aiming to fulfill the huge unmet medical needs of $36 billion estimated in 2019," said Dr. Ben Chien.
