聯生藥單株抗體新藥 UB-221 獲美國 FDA 核准 在慢性自發性蕁麻疹患者進行臨床一期試驗

聯合生物製藥(股)公司(聯生藥)今日宣布,其新型抗IgE單株抗體藥物 UB-221 已獲得美國FDA 核准在標準一線藥物H1 抗組織胺治療無效的慢性自發性蕁麻疹(Chronic Spontaneous Urticaria,CSU) 病患進行臨床一期試驗。慢性蕁麻疹的患病率約為1.8%。慢性自發性蕁麻疹發生率則約0.5〜1%。三分之二的慢性蕁麻疹是自發性的, 20至40歲之間是發病高峰期。

這是一項隨機、單盲、安慰劑對照、單次遞增劑量的臨床研究,目的在評估UB-221作為附加療法(add-on therapy)的安全性、耐受性、藥物動力學和藥效學。本次臨床試驗將收納32位CSU病患,接受靜脈輸注單一劑量 UB-221。投藥後,依規定的返診時間採集受試者的血液檢體進行分析,試驗全程共99天。
UB-221已證明其具有中和游離IgE的能力,其親和力是另一種目前市售的抗IgE單株抗體藥物的8倍。此外,UB-221已顯示通過與B細胞表面的CD23受體結合而更有效地減少IgE合成。猴子動物之藥物動力學研究表明,UB-221的血清半衰期是目前市售類似抗體藥物的兩倍。

UB-221也正在開發其它由IgE引起的過敏性疾病適應症,包括重度哮喘、過敏性鼻炎、嚴重食物過敏和異位性皮膚炎。

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United BioPharma Receives US FDA Approval for UB-221 Phase 1 IND for Chronic Spontaneous Urticaria

Taipei, Taiwan, November 8th , 2019 — United BioPharma (UBP) announced today that they have received Investigational New Drug (IND) approval from the U.S. FDA to conduct a phase 1 clinical trial with a novel anti-IgE monoclonal antibody UB-221, in patients suffering from chronic spontaneous urticaria (CSU) that is not adequately controlled by standard first-line H1-antihistamine treatments. The lifetime prevalence of chronic urticaria is approximately 1.8%. Chronic spontaneous urticaria occurs in 0.5~1% of the population at any point in time. Two out of three cases of chronic urticaria are spontaneous, with its incidence peaking between 20 and 40 years of age .

The phase 1 trial is a randomized, placebo-controlled, single-dose, dose-escalating study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of UB-221 as an add-on therapy in 32 patients with moderate to severe CSU.

UB-221 has demonstrated its ability to neutralize free/soluble IgE with 8 folds higher affinity than that of another currently marketed anti-IgE monoclonal antibody therapeutic. In addition, UB-221 has shown to be more effective to down-regulate/reduce IgE synthesis through binding to CD23 receptor on B cell surface. A PK study in monkeys demonstrated two times longer serum half-life of UB-221 than that of the current therapeutic antibody drug. UB-221 is also being developed as the biologic therapeutic for other IgE-mediated allergies, including severe asthma, allergic rhinitis, severe food allergy and atopic dermatitis.

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In shocking reversal, Biogen to submit experimental Alzheimer’s drug for approval

By MATTHEW HERPER @matthewherper OCTOBER 22, 2019

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In a shocking reversal, Biogen (BIIB) on Tuesday said that it would resurrect an Alzheimer’s drug that the company previously said had failed and will ask the Food and Drug Administration to approve it. The company said a “new analysis of a larger dataset” showed that the drug, aducanumab, reduced clinical decline in patients with early Alzheimer’s disease on multiple measures of the drug’s effectiveness. That directly contradicts a decision in March to halt studies of the therapy based on the recommendations of an independent monitoring board that was charged with protecting patients in the study. Aducanumab’s failure sent shock waves far beyond Biogen. It was thought to be the last of a series of drugs — the previous ones, from many different drug companies, all failed — that targeted a protein in the brain called beta amyloid. After Biogen’s announcement in March, most researchers and biotechnology executives saw little hope for a drug that would help patients with Alzheimer’s disease even as cases mount. 繼續閱讀

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Biogen’s good news on aducanumab could ‘open the floodgates’ for Alzheimer’s drugs

By DENNIS J. SELKOE OCTOBER 23, 2019

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One of the many things I’ve learned during four decades of doing research on Alzheimer’s disease is that the work always brings surprises. Biogen’s announcement on Tuesday about its experimental Alzheimer’s drug, aducanumab, was a big one.

Back in March, the company stopped two large Phase 3 clinical trials of the drug after futility analyses showed that aducanumab was unlikely to provide a benefit compared to placebo.

That decision was a blow to the hypothesis that a protein called beta-amyloid is a cause of Alzheimer’s. It cast a cloud over years of research, and many of us in the field began feeling like we were swimming upstream against pronouncements that anti-amyloid therapies won’t work. Several biopharmaceutical companies started rethinking their research in this area.

Biogen’s latest announcement is likely to give some in the field whiplash.

Why the reversal?

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