TWi Biotechnology Inc. Presents Positive Results from AC-201 CR Phase 2 Proof-of-Concept Study in Gout Patients in 2017 ACR/ARPH Annual Meeting

Wednesday, November 1, 2017 General News
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TAIPEI, Taiwan, Nov. 1, 2017 /PRNewswire/ -- TWi Biotechnology Inc., a clinical stage biotechnology company based in

Taiwan, today announced that positive results of the phase 2 trial, A Study of AC-201 Controlled-Release Tablet (CR Tablet) in Patients with Gout, will be presented at the 2017 ACR/ARHP annual meeting in San Diego,
United States. The trial demonstrated taking 100mg AC-201CR twice a day in combination with 40mg febuxostat, a xanthine oxidase inhibitor (OXI), significantly increased the treatment success rate from 55% to 64% (P=0.0337) and from 27% to 39% (P=0.0140) defined as reaching serum uric acid (sUA) concentration below 6mg/dL and 5mg/dL in 4 weeks, respectively. In addition, without colchicine or NSAID prophylaxis during the treatment period, the increased treatment success rate was not associated with an increase in the incidence rate of acute gout flare, which is the common problem when trying to bring down sUA quickly or to improve the clinical treatment success rate by taking high dose OXI or in combination with uricosuric agents. AC-201CR was well tolerated in the trial.

"We are very pleased to have the opportunity to present the trial results in the annual meeting of ACR/ARHP because it is the most important meeting in the field." said by Dr. Calvin C. Chen, president and CEO of TWi Biotechnology. "The poor compliance of the urate lowering therapy due to frequent gout flares at the initiation and the requirement of long titration time, as well as the low treatment success rate and safety concerns including severe skin toxicity, liver toxicity, or kidney toxicity offered by existing therapies are the major unmet needs for the management of sUA in patients with gout or hyperuricemia. Furthermore, the high prevalence of multiple metabolic diseases among patients makes the unique mode of actions of AC-201CR that inhibit the activation of NLRP3 inflammasome and the production of downstream IL-1beta/IL-18 more suitable for these patients. Clinical trials of AC-201 have demonstrated its benefit in controlling blood glucose levels and HbA1c in patients with type 2 diabetes. An anti-IL-1beta mAb also has been proved by a long term, large scale clinical trial to reduce heart disease rate in high risk patients. We have high hope that AC-201CR will help those patients suffering from metabolic diseases, and are looking for collaboration partners to advance the development works worldwide."

About the Study

The Phase 2 study (study code: AC-201-GOU-002) was a randomized, double-blind, placebo-controlled, multicenter study. This study was designed to test the urate-lowering effects, safety and tolerability of AC-201 controlled-release tablets (vs. placebo) in an initial dosing period as a monotherapy, followed by addition of febuxostat to test the efficacy and safety of the combination. At 14 clinical sites in Taiwan, the study enrolled 127 eligible subjects, who were confirmed with gout, and randomized in a 1:1 allocation ratio to either AC-201 CR or placebo over a 12-week treatment period and a 4-week follow-up period.

The primary efficacy endpoint was the proportion of subjects achieving serum uric acid concentration <6.0 mg/dL at Week 8. The major secondary efficacy endpoints were proportion of subjects achieving serum uric acid concentration <6.0 mg/dL or <5.0 mg/dL at each visit; number of gout flares per subject during each period and overall.

About Hyperuricemia and Gout

Gout is a medical condition usually 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. The active ingredient of AC-201 has been approved for treating patients with chronic rheumatic diseases in EU and Middle Eastern countries since mid-1990. 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 under 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 4 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 repositioned drugs for unmet medical needs, especially in the diseases associated with innate immunity. The company is building its product pipeline through in-licensing and internal research. TWi Biotechnology's product development pipeline includes two drug candidates for treating epidermolysis bullosa, gout, type II diabetes, hemophilic arthropathy, and immunodermatology diseases.

Media Contact:

Contact Person: Weishu Lu Phone Number: +886-2-26571788 ext.300 Email: [email protected]

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SOURCE TWi Biotechnology Inc.



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