TAIPEI, Taiwan, June 27, 2016 /PRNewswire/ -- TWi Biotechnology Inc. (TWiB), a clinical stage drug development company targeting rare, chronic, dermal and inflammatory diseases, announced today that it has completed patient enrollment in its Phase 2 clinical trial (Study code: AC-201-GOU-002) of AC-201CR for the treatment of gout. The Company expects to report top-line results from this study in the fourth quarter of 2016. The positive interim results of this proof-of-concept study were delivered in December, 2015.
TWiB launched its Phase 2 clinical study of AC-201CR for the treatment of gout in November 2014. The multi-center, double-blind, randomized, placebo-control Phase 2 study under US IND is being conducted in Taiwan, and is designed to evaluate AC-201CR's efficacy, safety and tolerability in up to 127 individuals with gout. Efficacy is measured based on American College of Rheumatology Guidelines for Management of Gout which includes measurements of serum urate level and gout flare number. This Phase 2 study is also evaluating multiple secondary endpoints, including metabolic/ inflammation markers and safety. The 12-week AC-201CR treatment period was composed of 3 periods of 4 weeks each with escalating treatment. In Period 1, subjects with gout and hyperuricemia were randomized at a 1:1 ratio to receive AC-201CR or placebo. In Period 2, subjects continued blinded study medication and initiated a urate-lowering therapy (ULT) of febuxostat 40 mg once daily. In Period 3, the ULT of subjects with sUA still over 6 mg/dL were titrated up to 80 mg febuxostat QD. For other subjects, the ULT was maintained until the end of the study. At Week 12, subjects discontinued blinded study medication but maintained their dose of febuxostat for a 4-week follow-up period.
Calvin Chen, Ph.D., Chief Executive Officer of TWiB commented, "Following a successful interim analysis that showed 89% of patients reached a treatment target of serum uric acid concentration below 6 mg/dL at Week 8 combining AC-201CR and 40 mg febuxostat relative to 67% of those taking 40 mg febuxostat alone, we are very pleased to have accomplished this clinical milestone for TWiB and are looking forward to completing the treatment phase of this study and releasing top-line data in the fourth quarter of this year. We are grateful to the individuals, their families and physicians who are participating in the studies. Our goal is to improve the treatment success rate of gout, which is hampered by the requirement of up-titration and frequent flare attacks with existing urate lowering therapies."
For more information on the Phase 2 study with AC-201CR for the treatment of gout, please visit ClinicalTrials.gov and reference identifier NCT02287818.
About Hyperuricemia and Gout
Gout is a medical condition characterized by recurrent attacks of acute inflammatory arthritis--a red, tender, warm, swollen joint caused by an inflammatory response to uric acid crystals deposited in joints and soft tissues as a result of elevated levels of uric acid in the blood (hyperuricemia). Urate crystals in joints can trigger acute arthritic flares, chronic destructive arthropathy, and formation of tophi. According to the U.S. National Health and Nutrition Examination Survey (NHANES) study, the prevalence of gout among US adults in 2007-2008 was 3.9% (8.3 million individuals).
About AC-201/ AC-201 CR
AC-201 is a first-in-class, orally available small molecule which has shown the dual abilities to inhibit URAT1 as well as the production and activity of caspase-1 and the cytokine interleukin-1Beta (IL-1Beta) through the inhibition of the assembly of the NLRP3 inflammasome. Inhibition of the NLRP3 inflammasome associated signaling pathway and IL-1Beta has been demonstrated to be effective in treating a variety of diseases including arthritis, gout, and diabetes mellitus (DM). The active ingredient of AC-201 has been approved for treating patients with chronic rheumatic diseases in France and subsequently in other EU and Middle Eastern countries such as Spain and Italy since mid-1990s. AC-201 CR is the controlled release oral formulation of AC-201.
TWi Biotechnology holds two US INDs for AC-201 -- one for controlling blood glucose in patients with type II diabetes and the other for treating gout in patients undertaking urate-lowering therapy. In addition to the good safety record of its active ingredient used in treating another chronic disease, AC-201 has undergone testing in several human clinical trials including 3 phase II trials with up to 6 months treatment period with a satisfactory safety profile demonstrated.
About TWi Biotechnology, Inc.
TWi Biotechnology, Inc. is a leading clinical stage biopharmaceutical company based in Taipei, Taiwan, specializing in the development of innovative new drugs for unmet medical needs, especially in the diseases associated with innate immunity. The company is building its product pipeline through a drug repositioning strategy. TWi Biotechnology's product development pipeline includes two drug candidates for treating type II diabetes, arthritis, gout, and immunodermatology diseases. TWi Biotechnology holds US and Taiwan orphan drug designations for AC-203 for Epidermolysis Bullosa treatment as well as two US INDs for the oral dosage form of the molecule for type 2 diabetes and gout treatment.
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SOURCE TWi Biotechnology, Inc.