Venatorx Pharmaceuticals扩大了HBV候选药物的抗感染产品组合

StephenW

Venatorx Pharmaceuticals Expands Anti-Infective Portfolio with HBV Candidate

Published: Mar 10, 2021
Logo
March 10, 2021 15:00 UTC


VNRX-9945 Selected as 3rd Generation Hepatitis B Virus Orally Bioavailable CpAM; Clinical Trial Application and Phase 1 Planned for Second Quarter 2021


MALVERN, Pa.--(BUSINESS WIRE)-- Venatorx Pharmaceuticals today announced that it has selected VNRX-9945, a core protein allosteric modulator (CpAM), as a clinical candidate for the treatment of chronic Hepatitis B Virus (HBV) infection. The Company plans to initiate clinical development in the second quarter 2021.

VNRX-9945 is a 3rd generation (highly potent), dual-mechanism viral replication inhibitor with activity against both nucleocapsid assembly and formation of cccDNA. VNRX-9945 demonstrates broad antiviral activity against multiple HBV genotypes in vitro and suppresses HBV DNA to below the lower limit of qualification in a mouse model of HBV infection.

There are over 250 million individuals chronically infected with chronic HBV worldwide who are at risk from complications due to liver disease and liver cancer. Chronic HBV infection is currently managed with nucleos(t)ide reverse transcriptase inhibitors (NrtIs) or pegylated-interferons that suppress HBV DNA replication and normalize alanine aminotransferase (ALT) levels leading to reductions in morbidity and mortality. Unfortunately, however, these agents are not curative and patients generally exhibit poor off-treatment responses that require indefinite therapy.

“Functional cure for chronic HBV infection remains the ultimate goal of HBV therapy,” said Christopher J. Burns, Ph.D., President and CEO of Venatorx. “The discovery and advancement of highly potent CpAMs, including VNRX-9945, represents an exciting opportunity to achieve deeper and more complete levels of antiviral suppression in chronic HBV patients, and has the potential to form the basis for future combination therapies that lead to a functional cure.”

“We have been actively pursuing next-generation CpAMs that could be included in a future combination regimen for the treatment of chronic HBV infection,” said Dr. Glen Coburn, Director of Virology at Venatorx. “Using a structure-assisted drug design approach, we identified VNRX-9945, a compound that exhibits antiviral activity that is amongst the best-in-class and possesses excellent oral bioavailability and safety properties. We look forward to facilitating the inclusion of VNRX-9945 in future combination regimens. Combining direct-acting antivirals with agents that knockdown antigen expression or stimulate immune responses may hold the key to optimizing treatment outcomes in patients with chronic HBV infection.”

Venatorx is pursuing mutually beneficial partnership and/or collaboration opportunities for VNRX-9945.

StephenW

Venatorx Pharmaceuticals扩大了HBV候选药物的抗感染产品组合

发行时间：2021年3月10日
标识
2021年3月10日15:00 UTC


VNRX-9945被选为第三代口服乙型肝炎病毒CpAM；临床试验申请和2021年第二季度计划的第一阶段


宾夕法尼亚州马尔文-（BUSINESS WIRE）-（美国商业资讯）-Venatorx Pharmaceuticals今天宣布，已选择核心蛋白变构调节剂（CpAM）VNRX-9945作为治疗慢性乙型肝炎病毒（HBV）感染的临床候选药物。该公司计划在2021年第二季度开始临床开发。

VNRX-9945是第三代（高效）双机制病毒复制抑制剂，对核衣壳组装和cccDNA形成均具有活性。 VNRX-9945在体外对多种HBV基因型表现出广泛的抗病毒活性，并将HBV DNA抑制到HBV感染小鼠模型中的合格下限以下。

全世界有超过2.5亿慢性感染慢性HBV的人由于肝病和肝癌而处于并发症危险中。目前，慢性乙肝病毒感染可通过抑制乙肝病毒DNA复制并使丙氨酸转氨酶（ALT）水平正常化的核苷酸（t）ide逆转录酶抑制剂（NrtIs）或聚乙二醇化干扰素来治疗，从而降低发病率和死亡率。然而，不幸的是，这些药物不能治愈，患者通常表现出较差的非治疗反应，需要无限期的治疗。

Venatorx总裁兼首席执行官Christopher J. Burns博士说：“功能性治愈慢性HBV感染仍然是HBV治疗的最终目标。” “包括VNRX-9945在内的强效CpAM的发现和发展，为在慢性HBV患者中获得更深，更完整的抗病毒抑制水平提供了令人振奋的机会，并有可能为将来的联合治疗奠定基础功能治愈。”

Venatorx病毒学总监Glen Coburn博士说：“我们一直在积极寻求可在将来的联合治疗方案中用于治疗慢性HBV感染的下一代CpAM。” “使用结构辅助药物设计方法，我们确定了VNRX-9945，这是一种具有抗病毒活性的化合物，在同类产品中名列前茅，并且具有出色的口服生物利用度和安全性。我们期待在未来的联合治疗方案中促进VNRX-9945的纳入。将直接作用的抗病毒药物与能降低抗原表达或刺激免疫反应的药物结合使用，可能是优化慢性HBV感染患者治疗效果的关键。”

Venatorx正在寻求VNRX-9945互惠互利的伙伴关系和/或合作机会。