好消息！ARO-HBV开始三联用药临床试验

newchinabok

sir 发表于 2019-4-24 23:19
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Arrowhead在慢性HBV患者中开始了三重组合队列，收入2500万美元。

感谢分享


新的三组联合队列(队列12)，包括JNJ-3989(以前是ARO-HBV)和其他未公开的药物

乙肝人1949

持续跟进

Fater

巨大的好消息！期待！

rxsm

该出手就出手啊……

hchu

“慢性乙型肝炎病毒患者在有限治疗时间内获得更高功能治愈率的转化药物。”

收下了。谢谢！

齐欢畅

Arrowhead Begins Triple Combination Cohort in Chronic HBV Patients and Earns $25 Million Milestone Payment from Janssen
Apr 24, 2019 at 7:30 AM EDT
PASADENA, Calif. --(BUSINESS WIRE)--Apr. 24, 2019-- Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today announced that it has begun dosing in a new triple combination cohort (cohort 12) that includes JNJ-3989 (formerly ARO-HBV) and additional undisclosed agents selected by Janssen Pharmaceuticals,
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PASADENA, Calif.--(BUSINESS WIRE)--Apr. 24, 2019-- Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today announced that it has begun dosing in a new triple combination cohort (cohort 12) that includes JNJ-3989 (formerly ARO-HBV) and additional undisclosed agents selected by Janssen Pharmaceuticals, Inc. in its ongoing Phase 1/2 study (AROHBV1001) in patients with chronic hepatitis B virus (HBV). In connection with the start of this new cohort, Arrowhead has earned a $25 million milestone payment from Janssen Pharmaceuticals, Inc., part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

Christopher Anzalone, Ph.D., president and chief executive officer at Arrowhead, said: “Both Arrowhead and Janssen share the aim to advance transformational medicines that achieve higher rates of functional cure with a finite treatment duration for patients with chronic hepatitis B viral infection. Beginning this new triple combination cohort in our ongoing AROHBV1001 study has the potential to generate valuable data rapidly.”

AROHBV1001 (NCT03365947) is a Phase 1/2 clinical study evaluating the safety, tolerability, and pharmacokinetic effects of single-ascending doses (SAD) of ARO-HBV in healthy adult volunteers, as well as the safety, tolerability, and pharmacodynamic effects of multiple-ascending doses (MAD) of ARO-HBV in patients with chronic HBV.

Arrowhead entered into a license and collaboration agreement with Janssen in October 2018 to develop and commercialize ARO-HBV. Under the initial terms of the HBV license agreement, Arrowhead was eligible to receive a $50 million milestone payment linked to a Phase 2 study. Arrowhead and Janssen subsequently amended the HBV license agreement to accelerate the payment of $25 million of the $50 million Phase 2 milestone with the initiation of cohort 12 of the AROHBV1001 trial. Arrowhead is eligible to receive the remaining $25 million upon the initiation of a Phase 2 study by Janssen.

Hepatitis B infection is a life-threatening viral infection of the liver, which can cause cirrhosis — scarring of liver tissue — and liver cancer if the infection becomes chronic. The World Health Organization cites that hepatitis B is a global public health problem with 257 million people living with the disease, resulting in 887,000 deaths in 2015.1 While a preventive vaccine is available, cure rates for those infected remain low and most patients will endure lifelong therapy.

About Arrowhead Pharmaceuticals

Arrowhead Pharmaceuticals develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing.

For more information, please visit www.arrowheadpharma.com, or follow us on Twitter @ArrowheadPharma. To be added to the Company's email list and receive news directly, please visit http://ir.arrowheadpharma.com/email-alerts.

Safe Harbor Statement under the Private Securities Litigation Reform Act:

This news release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These statements are based upon our current expectations and speak only as of the date hereof. Our actual results may differ materially and adversely from those expressed in any forward-looking statements as a result of various factors and uncertainties, including the safety and efficacy of our product candidates, the duration and impact of regulatory delays in our clinical programs, our ability to finance our operations, the likelihood and timing of the receipt of future milestone and licensing fees, the future success of our scientific studies, our ability to successfully develop and commercialize drug candidates, the timing for starting and completing clinical trials, rapid technological change in our markets, and the enforcement of our intellectual property rights. Our most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q discuss some of the important risk factors that may affect our business, results of operations and financial condition. We assume no obligation to update or revise forward-looking statements to reflect new events or circumstances.

齐欢畅

StephenW

我认为第三种药物可能是他们自己的TLR7激动剂.


https://www.healio.com/hepatology/chronic-hepatitis/news/online/%7B340266ff-3b48-479f-96e3-a6e11f6ccfb2%7D/video-janssen-hbv-pipeline-focuses-on-increasing-functional-cure-rates

VIENNA — In this exclusive video from the International Liver Congress 2019, James Merson, PhD, global therapeutic area head for infectious diseases at Janssen, discusses the company’s pipeline for hepatitis B with a focus on improving functional cure rates.

“For us at Janssen, HBV and being able to increase functional cure rates of patients living with HBV is an important part of our strategy as to how we can manage the disease more effectively than the current treatments do today,” Merson told Healio Gastroenterology and Liver Disease.

“We have a number of different modalities that we’re looking at to increase functional cure rates,” he continued. “Standard of care today — nucleos(t)ide analogues — get around 3% functional cure rates. We’re looking to make a meaningful difference for those patients, so they no longer have to take lifelong therapies to manage their disease.”

Merson provided details on the company’s HBV pipeline that includes two capsid assembly modulators that have shown “impressive” antiviral activity in phase 2a studies, a small interfering RNA molecule that has demonstrated HBV surface antigen suppression in a phase 2a study that continued after 3 months of stopping treatment, and a toll-like receptor 7 agonist that has shown promise in early phase 1 trials.

“As we look forward, we are trying to find the optimal doses and dosing frequency for each of these modulators and how best to combine each one of those with various partners to see whether we can truly increase the functional cure rates in patients chronically infected with HBV rates.”

Reference:

Harrison SA. Abstract SAT-300. Presented at: International Liver Congress; April 10-14, 2019; Vienna, Austria.

Disclosure: Merson is the global therapeutics area head for infectious diseases at Janssen.
维也纳 - 在2019年国际肝病大会的独家视频中，Janssen传染病全球治疗领域负责人James Merson博士讨论了该公司的乙型肝炎管道，重点是提高功能性治愈率。

“对于我们在Janssen，HBV以及能够提高HBV患者的功能治愈率是我们策略的一个重要部分，因为我们比目前的治疗方法更有效地治疗疾病，”Merson告诉Healio Gastroenterology and Liver疾病。

“我们有许多不同的方式，我们正在寻求提高功能治愈率，”他继续说。 “今天的护理标准 - 核苷（酸）类似物 - 大约3％的功能治愈率。我们希望为那些患者创造意义差异，因此他们不再需要终生疗法来治疗他们的疾病。”

Merson提供了该公司HBV管道的详细信息，其中包括两个衣壳装配调节剂，这些调节剂在2a期研究中显示出“令人印象深刻的”抗病毒活性，这是一种小干扰RNA分子，在2a期研究中证实HBV表面抗原抑制，持续3个月后停止治疗，以及在早期1期试验中显示出前景的Toll样受体激动剂。

“在我们展望未来的过程中，我们正在努力寻找每种调节剂的最佳剂量和给药频率，以及如何最好地将这些调节剂中的每一种与各自的合作伙伴相结合，看看我们是否能够真正提高慢性感染患者的功能治愈率。 HBV率。“

参考：

哈里森SA。摘要SAT-300。发表于：国际肝脏大会; 2019年4月10日至14日;维也纳，奥地利。

披露：Merson是Janssen传染病的全球治疗领域负责人。

newchinabok

StephenW 发表于 2019-4-25 09:14
我认为第三种药物可能是他们自己的TLR7激动剂.

有道理。

左罗

令人欣慰的好消息，当然值得期待！