楊梅報告乙肝陽性數據

StephenW

Arbutus Reports Positive Hepatitis B Data
Sep. 22, 2020 9:48 AM ET
|
Summary

Arbutus reports positive data for AB-729 for chronic hepatitis B

Arbutus Biopharma Corporation (ABUS) announced continued positive data from a continuing Phase 1a/1b clinical trial of AB-729. The new data showed that a single subcutaneous injection of 90 mg of AB-729 leads to a mean HBsAg decline of 1.23 log10 IU/mL at week 12 in patients with chronic HBV.

AB-729-001 is an ongoing first-in-human clinical trial. It consists of three main parts. The Part 1 consisted of three cohorts of healthy subjects. These subjects were randomized on a 4:2 basis and were administered single doses of AB-729 or placebo. William Collier, President and CEO of Arbutus said:

    The 90 mg single-dose 12-week data coupled with our previously disclosed 60 mg single-dose 12-week data mean that we now have two doses which have demonstrated meaningful reductions in HBsAg with a favorable safety and tolerability profile."

Part 2 of the trial has non-cirrhotic, HBeAg positive or negative, chronic HBV subjects. These participants have a background of ucleos(t)ide therapy with HBV DNA below the limit of quantitation. They were given single doses of 60 mg to 180 mg of AB-729. Another cohort in Part 2 consisted of HBV DNA positive chronic HBV subjects and was given 90 mg single-dose of AB-729.

Part 3 consisted of chronic HBV subjects, HBV DNA negative first, and HBV DNA positive later. These subjects are being given multi-doses of AB-729 for up to six months. The data showed that the mean HBsAg decrease reported in the 90 mg single-dose cohort is in line with that reported in previous single-dose cohorts. The data also demonstrates the consistent efficacy of the drug candidate as well as corroborating its favorable safety profile at the intermediate dosage. The company is using this data for continued assessment of the 90 mg dosage in its multi-dose portion of ongoing clinical trial.

AB-729 is an RNA interference (RNAi) therapeutic. It uses Arbutus's novel covalently conjugated N-acetylgalactosamine (GalNAc) delivery technology to target hepatocytes. The use of its delivery technology allows for subcutaneous administration. The drug candidate works by inhibiting viral replication and reducing all HBV antigens such as hepatitis B surface antigen in preclinical models. It is widely believed that the reduction in hepatitis B surface antigen may be a key factor in reviving the immune system of a patient. In its current single- and multi-dose Phase 1a/1b clinical trial, the drug candidate has shown the ability to bring a meaningful decline in hepatitis B surface antigen.

Arbutus Biopharma is a biopharmaceutical company and is mainly engaged in discovering, developing, and commercializing treatment for chronic hepatitis B virus (HBV) infection. The company is currently working on multiple drug candidate which may be used as combination therapy for such infections. It is also working on a potential treatment candidate for COVID-19.

Investment Thesis: Arbutus stock managed to retain its levels during the pandemic outbreak. The company has provided solid returns to its investors and is expected to retain the trend. While Arbutus has not reported profits in past 12 months, it has shown robust revenue growth.

StephenW

楊梅報告乙肝陽性數據
2020年9月22日，美國東部時間上午9:48
|
摘要

Arbutus報告了慢性乙型肝炎的AB-729陽性數據

Arbutus Biopharma Corporation（ABUS）宣布了AB-729正在進行的1a / 1b期臨床試驗的持續陽性數據。新數據顯示，慢性HBV患者第12週單次皮下注射90 mg AB-729導致平均HBsAg下降1.23 log10 IU / mL。

AB-729-001是一項正在進行的人體首次臨床試驗。它由三個主要部分組成。第1部分由三組健康受試者組成。這些受試者以4：2為基礎隨機分組，並接受單劑量的AB-729或安慰劑。 Arbutus總裁兼首席執行官William Collier說：

    90毫克單劑量12週數據加上我們之前披露的60毫克單劑量12週數據意味著我們現在有兩種劑量已證明可有效降低HBsAg，並具有良好的安全性和耐受性。”

該試驗的第二部分包括非肝硬化，HBeAg陽性或陰性的慢性HBV受試者。這些參與者的背景是，HBV DNA低於定量限的核苷酸治療。他們給了60毫克至180毫克的AB-729單劑量。第2部分中的另一個隊列由HBV DNA陽性慢性HBV受試者組成，並給予90 mg單劑量AB-729。

第3部分由慢性HBV受試者組成，首先是HBV DNA陰性，然後是HBV DNA陽性。這些受試者被給予多達六個月的多劑量AB-729。數據顯示，在90 mg單劑量隊列中報告的平均HBsAg下降與以前的單劑量隊列中報告的一致。數據還證明了候選藥物的一致療效以及證實其在中等劑量時的有利安全性。該公司正在使用此數據在正在進行的臨床試驗的多劑量部分中繼續評估90 mg劑量。

AB-729是一種RNA干擾（RNAi）治療劑。它使用Arbutus的新型共價共軛N-乙酰半乳糖胺（GalNAc）遞送技術靶向肝細胞。其遞送技術的使用允許皮下施用。該候選藥物通過抑制病毒複製並減少臨床前模型中的所有HBV抗原（例如乙肝表面抗原）而起作用。廣泛認為，乙型肝炎表面抗原的減少可能是恢復患者免疫系統的關鍵因素。在其當前的單劑量和多劑量1a / 1b期臨床試驗中，候選藥物顯示出能夠引起乙型肝炎表面抗原顯著下降的能力。

Arbutus Biopharma是一家生物製藥公司，主要從事發現，開發和商業化慢性B型肝炎病毒（HBV）感染的治療方法。該公司目前正在研究多種候選藥物，這些候選藥物可用作此類感染的聯合療法。它還正在研究COVID-19的潛在治療候選方案。

投資論點：在大流行期間，楊梅的股票設法保持了水平。該公司已為其投資者提供了可觀的回報，並有望保持這一趨勢。儘管Arbutus過去12個月未報告利潤，但收入增長強勁。