TAIPEI, Taiwan, Nov. 1, 2017 /PRNewswire/ — TWi Biotechnology Inc., a analytic date biotechnology aggregation based in Taiwan, today appear that absolute after-effects of the appearance 2 trial, A Abstraction of AC-201 Controlled-Release Tablet (CR Tablet) in Patients with Gout, will be presented at the 2017 ACR/ARHP anniversary affair in San Diego, United States. The balloon accustomed demography 100mg AC-201CR alert a day in aggregate with 40mg febuxostat, a xanthine oxidase inhibitor (OXI), decidedly added the analysis success amount from 55% to 64% (P=0.0337) and from 27% to 39% (P=0.0140) authentic as extensive serum uric acerbic (sUA) absorption beneath 6mg/dL and 5mg/dL in 4 weeks, respectively. In addition, after colchicine or NSAID prophylaxis during the analysis period, the added analysis success amount was not associated with an access in the accident amount of astute gout flare, which is the accepted botheration back aggravating to accompany bottomward sUA bound or to beforehand the analytic analysis success amount by demography aerial dosage OXI or in aggregate with uricosuric agents. AC-201CR was able-bodied acceptable in the trial.
“We are actual admiring to accept the befalling to present the balloon after-effects in the anniversary affair of ACR/ARHP because it is the best important affair in the field.” said by Dr. Calvin C. Chen, admiral and CEO of TWi Biotechnology. “The poor acquiescence of the urate blurred analysis due to common gout flares at the admission and the claim of continued titration time, as able-bodied as the low analysis success amount and assurance apropos including astringent bark toxicity, alarmist toxicity, or branch toxicity offered by absolute therapies are the above unmet needs for the administration of sUA in patients with gout or hyperuricemia. Furthermore, the aerial prevalence of assorted metabolic diseases amid patients makes the different approach of accomplishments of AC-201CR that arrest the activation of NLRP3 inflammasome and the accumulation of after IL-1beta/IL-18 added acceptable for these patients. Analytic trials of AC-201 accept accustomed its account in authoritative claret glucose levels and HbA1c in patients with blazon 2 diabetes. An anti-IL-1beta mAb additionally has been accepted by a continued term, ample calibration analytic balloon to abate affection ache amount in aerial accident patients. We accept aerial achievement that AC-201CR will advice those patients adversity from metabolic diseases, and are attractive for accord ally to beforehand the development works worldwide.”
About the Study
The Appearance 2 abstraction (study code: AC-201-GOU-002) was a randomized, double-blind, placebo-controlled, multicenter study. This abstraction was advised to analysis the urate-lowering effects, assurance and tolerability of AC-201 controlled-release tablets (vs. placebo) in an antecedent dosing aeon as a monotherapy, followed by accession of febuxostat to analysis the ability and assurance of the combination. At 14 analytic sites in Taiwan, the abstraction enrolled 127 acceptable subjects, who were accepted with gout, and randomized in a 1:1 allocation arrangement to either AC-201 CR or placebo over a 12-week analysis aeon and a 4-week aftereffect period.
The primary ability endpoint was the admeasurement of capacity accomplishing serum uric acerbic absorption <6.0 mg/dL at Week 8. The above accessory ability endpoints were admeasurement of capacity accomplishing serum uric acerbic absorption <6.0 mg/dL or <5.0 mg/dL at anniversary visit; cardinal of gout flares per accountable during anniversary aeon and overall.
About Hyperuricemia and Gout
Gout is a medical action usually characterized by alternate attacks of astute anarchic arthritis — a red, tender, warm, bloated collective acquired by an anarchic acknowledgment to uric acerbic crystals deposited in joints and bendable tissues as a aftereffect of animated levels of uric acerbic in the claret (hyperuricemia). Urate crystals in joints can activate astute arthritic flares, abiding annihilative arthropathy, and accumulation of tophi. According to the U.S. National Health and Nutrition Examination Survey (NHANES) study, the prevalence of gout amid US adults in 2007-2008 was 3.9% (8.3 actor individuals).
About AC-201/ AC-201 CR
AC-201 is a first-in-class, orally accessible baby molecule, which has apparent the bifold abilities to arrest URAT1 as able-bodied as the accumulation and action of caspase-1 and the cytokine Interleukin-1Beta (IL-1Beta) through the inhibition of the accumulation of the NLRP3 inflammasome. Inhibition of the NLRP3 inflammasome associated signaling alleyway and IL-1Beta has been accustomed to be able in alleviative a array of diseases including arthritis, gout, and diabetes mellitus. The alive additive of AC-201 has been accustomed for alleviative patients with abiding arthritic diseases in EU and Middle Eastern countries back mid-1990. AC-201 CR is the controlled absolution articulate conception of AC-201.
TWi Biotechnology holds two US INDs for AC-201 – one for authoritative claret glucose in patients with blazon II diabetes and the added for alleviative gout in patients beneath urate-lowering therapy. In accession to the acceptable assurance almanac of its alive additive acclimated in alleviative accession abiding disease, AC-201 has undergone testing in several animal analytic trials including 4 appearance II trials with up to 6 months analysis aeon with a satisfactory assurance contour demonstrated.
About TWi Biotechnology, Inc.
TWi Biotechnology, Inc. is a arch analytic date biopharmaceutical aggregation based in Taipei, Taiwan, specializing in the development of repositioned drugs for unmet medical needs, abnormally in the diseases associated with congenital immunity. The aggregation is architecture its artefact activity through in-licensing and centralized research. TWi Biotechnology’s artefact development activity includes two biologic candidates for alleviative epidermolysis bullosa, gout, blazon II diabetes, hemophilic arthropathy, and immunodermatology diseases.
Contact Person: Weishu LuPhone Number: 886-2-26571788 ext.300Email: Weishu.Lu@twibiotech.com
View aboriginal content:http://www.prnewswire.com/news-releases/twi-biotechnology-inc-presents-positive-results-from-ac-201-cr-phase-2-proof-of-concept-study-in-gout-patients-in-2017-acrarph-annual-meeting-300547146.html
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