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Neuraptive Therapeutics宣布在2024年美国手外科学会(ASSH)年会上公布NTX-001的2期Topline中期结果

Neuraptive Therapeutics Announces Presentation of Phase 2 Topline Interim Results for NTX-001 at the 2024 American Society for Surgery of the Hand (ASSH) Annual Meeting

businesswire 等信源发布 2024-09-19 22:31

可切换为仅中文


CHESTERBROOK, Pa.--(BUSINESS WIRE)--Neuraptive Therapeutics Inc., a leading biopharmaceutical company focused on novel treatments for peripheral nerve injuries, today announced that interim topline results from its ongoing Phase 2 NEUROFUSE Study will be presented at the 2024 American Society for Surgery of the Hand (ASSH) Annual Meeting, held September 19-21 in Minneapolis, MN.

宾夕法尼亚州切斯特布鲁克(商业新闻短讯)--专注于周围神经损伤新型治疗的领先生物制药公司Neuraptive Therapeutics Inc.今天宣布,正在进行的第二阶段NEUROFUSE研究的中期topline结果将在9月19日至21日于明尼苏达州明尼阿波利斯举行的2024年美国手外科学会(ASSH)年会上公布。

The presentation, titled Safety and Efficacy of NTX-001 in the Treatment of Acute Single Transected Peripheral Nerve Injuries: A Phase 2 Randomized Controlled Trial, was awarded a Top 10 Best Paper designation and will be presented by Dr. David Brogan of Washington University during the scientific paper session on Thursday, September 19..

这篇题为“NTX-001治疗急性单次横断周围神经损伤的安全性和有效性:一项2期随机对照试验”的演讲获得了前10名最佳论文提名,将由华盛顿大学的David Brogan博士在9月19日星期四的科学论文会议上发表。。

The presentation will highlight interim findings from the 24-week analysis of the NEUROFUSE study, which evaluates the safety and efficacy of NTX-001 in patients suffering from acute, single-transected upper extremity peripheral nerve injuries. NTX-001 is a drug-device combination designed to improve the speed and durability of functional recovery when used alongside standard surgical repair.

该演讲将重点介绍NEUROFUSE研究24周分析的中期结果,该研究评估NTX-001在急性单次横断上肢周围神经损伤患者中的安全性和有效性。NTX-001是一种药物装置组合,旨在与标准手术修复一起使用时提高功能恢复的速度和耐久性。

These results represent an important milestone in the continued development of NTX-001 as a novel treatment option for peripheral nerve injuries..

这些结果代表了NTX-001作为周围神经损伤的新型治疗选择的持续发展的重要里程碑。。

Key interim findings at 24 weeks include:

24周的主要中期调查结果包括:

NTX-001 demonstrated a significant improvement in MHQ total scores at 8- and 24 weeks post-operation compared to standard of care alone

NTX-001显示,与单独的标准护理相比,术后8周和24周的MHQ总分显着改善

There were no safety findings associated with the use of NTX-001

没有与使用NTX-001相关的安全性发现

At all-time points, patients treated with NTX-001 demonstrated significantly reduced post-operative pain compared with SOC alone.

在所有时间点,与单独的SOC相比,用NTX-001治疗的患者术后疼痛显着降低。

These results underscore the potential of NTX-001 to enhance functional recovery in peripheral nerve injury patients and support further development.

这些结果强调了NTX-001增强周围神经损伤患者功能恢复并支持进一步发展的潜力。

According to Dr. Brogan, lead author on the paper and primary investigator at Washington University in St. Louis, “traumatic peripheral nerve transections are an unsolved problem in hand and upper extremity surgery, and the potential use of PEG fusion to meet this challenge has gained considerable interest among clinicians who deal with these devastating injuries.

该论文的主要作者、圣路易斯华盛顿大学的主要研究者布罗根博士表示,“创伤性周围神经切断是手部和上肢手术中尚未解决的问题,PEG融合技术在应对这一挑战方面的潜在用途引起了处理这些毁灭性损伤的临床医生的极大兴趣。

This data demonstrating improvement in pain and patient-reported outcomes is an exciting first step in addressing the needs of these patients.”.

这些数据表明疼痛和患者报告结果的改善是解决这些患者需求的令人兴奋的第一步。”。

'We are pleased to share these promising interim results from our Phase 2 trial of NTX-001 at such an important Scientific conference, and look forward to sharing full study results at future scientific conferences,' said Evan Tzanis, Chief Operating Officer and Head of R&D at Neuraptive Therapeutics, Inc.

Neuraptive Therapeutics,Inc.首席运营官兼研发主管Evan Tzanis说:“我们很高兴在如此重要的科学会议上分享NTX-001第二阶段试验的这些有希望的中期结果,并期待在未来的科学会议上分享完整的研究结果。”。

'We are immensely grateful to all those involved in this study, including the investigators, supporting staff at the clinical sites, our team, and most importantly, the patients who participated in the study,' said Tzanis..

Tzanis说:“我们非常感谢所有参与这项研究的人,包括研究人员、临床现场的支持人员、我们的团队,最重要的是,还有参与研究的患者。”。。

About ASSH

关于ASSH

The American Society for Surgery of the Hand is the oldest medical society dedicated to the hand and upper extremity. Its mission is to advance the science and practice of hand and upper extremity surgery through education, research, and advocacy on behalf of patients and practitioners. For more information, please visit www.assh.org..

美国手外科学会是专门研究手和上肢的最古老的医学学会。它的使命是通过代表患者和从业者的教育、研究和宣传来推进手部和上肢手术的科学和实践。有关更多信息,请访问www.assh.org。。

About Neuraptive Therapeutics, Inc.

关于Neuraptive Therapeutics,Inc。

Neuraptive Therapeutics, Inc. is dedicated to the innovation and development of medical products and therapeutics to repair and regenerate peripheral nerves. The company is focused on addressing the unmet medical needs of patients and physicians dealing with the complex challenges of nerve injuries..

Neuraptive Therapeutics,Inc.致力于医疗产品和疗法的创新和开发,以修复和再生周围神经。该公司专注于解决患者和医生未满足的医疗需求,以应对神经损伤的复杂挑战。。

Notice Regarding Forward-Looking Statements

关于前瞻性声明的通知

This press release contains forward-looking statements subject to various risks and uncertainties. Actual results could materially differ from those anticipated in the forward-looking statements due to various factors. Neuraptive Therapeutics, Inc. disclaims any obligation to update the information contained in these forward-looking statements..

本新闻稿包含具有各种风险和不确定性的前瞻性声明。由于各种因素,实际结果可能与前瞻性声明中的预期结果存在重大差异。Neuraptive Therapeutics,Inc.否认有义务更新这些前瞻性声明中包含的信息。。