The first patient undergoing wisdom tooth extraction has been dosed with HT-6184 to evaluate its effect on post-procedure diagnostic biomarkers of inflammation and pain, as well as to evaluate its safety and tolerability.

第一位接受智齿拔除的患者服用了HT-6184，以评估其对炎症和疼痛的术后诊断生物标志物的影响，并评估其安全性和耐受性。

LEHI, Utah, Feb. 15, 2024 /PRNewswire/ -- Halia Therapeutics, a clinical-stage biopharmaceutical company pioneering a novel class of small molecule medications designed to combat inflammation, today announced the initiation of its Phase II randomized, single-dose, placebo-controlled, double-blind, parallel-group clinical study (NCT06241742) to evaluate the efficacy of  HT-6184, a selective and orally bioavailable first-in-class inhibitor of the NEK7/NLRP3 inflammasome, a main driver of inflammatory diseases.

犹他州莱希，2024年2月15日/PRNewswire/--临床阶段生物制药公司Halia Therapeutics开创了一类旨在对抗炎症的新型小分子药物，今天宣布开始其II期随机，单剂量，安慰剂对照，双盲，平行组临床研究（NCT06241742），以评估HT-6184的疗效，NEK7/NLRP3炎性体（炎症性疾病的主要驱动因素）的选择性和口服生物可利用的一流抑制剂。

The study will enroll up to 80 adults in post-surgical extraction of two or more molars, at least one of which must be partially or fully impacted in the mandibular bone. The study's primary objective is to evaluate the effect of HT-6184 on post-procedure diagnostic biomarkers of inflammation and pain, as well as to evaluate the safety and tolerability of HT-6184..

这项研究将招募多达80名成年人在手术后拔除两颗或更多颗臼齿，其中至少一颗必须部分或完全埋伏在下颌骨中。该研究的主要目的是评估HT-6184对炎症和疼痛的术后诊断生物标志物的影响，以及评估HT-6184的安全性和耐受性。。

'The initiation of this trial to assess the efficacy of HT-6184 to reduce acute inflammation and pain marks another significant milestone for Halia in further evaluating the potential of targeting the NLRP3 inflammasome to treat a wide spectrum of immunological and inflammatory diseases,' said Margit M.

Margit M。

Janát-Amsbury, MD, Ph.D., Chief Medical Officer of Halia Therapeutics. 'The recent positive results of our Phase I trial investigating HT-6184 in healthy volunteers are extremely encouraging and validate the functional activity of HT-6184 in reducing inflammatory cytokines.'.

Janát-Amsbury，医学博士，博士，Halia Therapeutics首席医疗官。”我们在健康志愿者中研究HT-6184的I期试验的最新积极结果非常令人鼓舞，并验证了HT-6184在减少炎性细胞因子方面的功能活性。”。

'This randomized Phase II clinical study marks the second trial following the initiation in December of our Phase IIa clinical study to evaluate HT-6184 for lower-risk myelodysplastic syndromes (LR-MDS),' noted Dave Bearss, Ph.D., President, and Chief Executive Officer at Halia Therapeutics. 'We look forward to assessing the potential benefit of our NLRP3 inflammasome inhibitor for patients undergoing a procedure that typically induces significant pain and inflammation and apply this to patients who suffer from many inflammation-related diseases.'.

Halia Therapeutics总裁兼首席执行官戴夫·贝尔斯（DaveBearss）博士指出：“这项随机II期临床研究标志着我们在12月开始进行II a期临床研究后的第二次试验，以评估HT-6184对低风险骨髓增生异常综合征（LR-MDS）的疗效。”我们期待着评估我们的NLRP3炎性体抑制剂对经历通常引起显着疼痛和炎症的手术的患者的潜在益处，并将其应用于患有许多炎症相关疾病的患者。”。

About HT-6184 Clinical Trial to Reduce Inflammation and Pain

关于HT-6184减轻炎症和疼痛的临床试验

The clinical trial (NCT06241742) is a Phase II randomized, single-dose, placebo-controlled, double-blind, parallel-group study designed to evaluate the ability of HT-6184 to attenuate diagnostic biomarkers of post-procedure acute inflammation and manage pain following third molar extraction. Subjects will be given a single oral dose of HT-6184 or placebo before oral surgery to remove their third molar teeth and will be monitored to rate their pain intensity and for biomarkers of post-procedure acute inflammation with 5 blood draws and 2 follow-up appointments on day 1 and day 2 after surgery, in addition to follow-up phone calls 5-7 days after surgery.

临床试验（NCT06241742）是一项II期随机，单剂量，安慰剂对照，双盲，平行组研究，旨在评估HT-6184减弱术后急性炎症诊断生物标志物的能力，并管理第三磨牙拔除后的疼痛。在口腔手术前，受试者将被给予单次口服剂量的HT-6184或安慰剂以去除他们的第三磨牙，并将被监测以评估他们的疼痛强度和术后急性炎症的生物标志物，并在手术后第1天和第2天进行5次抽血和2次随访预约，以及手术后5-7天的随访电话。

The study is being conducted at JBR/CenExcel in Salt Lake City, Utah. Further information regarding this Phase II randomized study, including eligibility and exclusion criteria, can be found on clinicaltrials.gov or by calling 801-261-2000..

这项研究正在犹他州盐湖城的JBR/CenExcel进行。关于这项II期随机研究的更多信息，包括资格和排除标准，可以在clinicaltrials.gov上找到，也可以致电801-261-2000。。

About the Post Procedural Inflammatory Response

关于术后炎症反应

Globally, over 300 million major surgical procedures are performed each year1. Many of these surgeries lead to inflammatory responses that complicate recovery and lead to acute pain and loss of productivity for patients recovering from the surgery.

在全球范围内，每年进行超过3亿次主要外科手术1。这些手术中的许多会导致炎症反应，使恢复复杂化，并导致急性疼痛和从手术中恢复的患者生产力下降。

About NLRP3

关于NLRP3

NLRP3, an innate immune sensor, is activated in response to various pathogenic and sterile stimuli. Activation of NLRP3 triggers the release of the pro-inflammatory cytokines IL-1β and IL-18 and induces a lytic cell death process called pyroptosis. These processes lead to systemic chronic inflammation.

NLRP3是一种先天免疫传感器，可响应各种致病性和无菌刺激而被激活。NLRP3的激活触发促炎细胞因子IL-1β和IL-18的释放，并诱导称为pyroptosis的溶解性细胞死亡过程。这些过程导致全身性慢性炎症。

Halia's therapeutic inhibition of NLRP3 prevents the formation of the NLRP3 inflammasome and promotes its disassembly once formed, thereby inhibiting the production and release of IL-1β and IL-18. Persistent activation of the NLRP3 inflammasome is thought to drive the onset and progression of many conditions, including fibrotic, dermatological, and auto-inflammatory diseases.

Halia对NLRP3的治疗性抑制作用可防止NLRP3炎性体的形成，并在形成后促进其分解，从而抑制IL-1β和IL-18的产生和释放。NLRP3炎性体的持续激活被认为可以驱动许多疾病的发作和进展，包括纤维化，皮肤病和自身炎症性疾病。

Significant neurodegenerative and neuroinflammatory disorders such as Alzheimer's disease, Parkinson's disease, and multiple sclerosis are also driven by NLRP3 activation..

NLRP3激活也会导致严重的神经退行性疾病和神经炎症性疾病，例如阿尔茨海默病，帕金森病和多发性硬化症。。

About HT-6184

关于HT-6184

HT-6184 represents an innovative approach as it is the first drug candidate to target the protein NEK7 through an allosteric mechanism. NEK7 is an essential component of the NLRP3 inflammasome and is critical for its assembly and the maintenance of NLRP3 activity. In preclinical models, Halia has shown that inhibiting the ability of NEK7 to bind to NLRP3 leads to a disruption in the formation of the NLRP3 inflammasome complex, thereby inhibiting the signaling from the inflammasome and reducing the inflammatory response.

HT-6184代表了一种创新的方法，因为它是第一个通过变构机制靶向蛋白质NEK7的候选药物。NEK7是NLRP3炎性体的重要组成部分，对其组装和维持NLRP3活性至关重要。在临床前模型中，Halia表明，抑制NEK7与NLRP3结合的能力会导致NLRP3炎性体复合物形成的破坏，从而抑制炎性体的信号传导并减少炎症反应。

Preclinical models also showed that in addition to disrupting the formation of the NLRP3 inflammasome, HT-6184 promotes the disassembly of the inflammasome once activated (Halia unpublished data)..

临床前模型还表明，除了破坏NLRP3炎性体的形成外，HT-6184还促进了一旦激活的炎性体的分解（Halia未发表的数据）。。

About Halia Therapeutics, Inc.

关于Halia Therapeutics，Inc。

Halia Therapeutics is discovering and developing a pipeline of novel therapeutics to improve patients' lives with chronic inflammatory disorders and neurodegenerative diseases, with its initial programs targeting NEK7 and LRRK2. Halia's lead candidate, HT-6184, a novel NEK7/NLRP3 inhibitor, has completed a Phase I study (NCT05447546) evaluating the safety and tolerability of HT-6184 when administered as single or multiple oral doses at escalating dose levels in healthy volunteer subjects and also recently initiated a Phase II to evaluate the efficacy of HT-6184 for the treatment of lower-risk myelodysplastic syndromes (LR-MDS).

Halia Therapeutics正在发现和开发一系列新疗法，以改善慢性炎症性疾病和神经退行性疾病患者的生活，其最初的计划针对NEK7和LRRK2。Halia的主要候选药物HT-6184是一种新型NEK7/NLRP3抑制剂，已完成I期研究（NCT05447546）评估HT-6184在健康志愿者受试者中以递增剂量水平单次或多次口服给药时的安全性和耐受性，并且最近开始了II期评估HT-6184治疗低风险骨髓增生异常综合征（LR-MDS）的疗效。

The company is headquartered in Lehi, Utah. For more info, visit www.haliatx.com or follow us on LinkedIn and Twitter (X)..

该公司总部位于犹他州莱希。欲了解更多信息，请访问www.haliatx.com或在LinkedIn和Twitter（X）上关注我们。。

Company Contact:

公司联系人：

James Dye+1.385.355.4315[email protected]

James Dye+1.385.355.4315[受电子邮件保护]

Media Contact:

媒体联系人：

Ignacio Guerrero-Ros, Ph.D.Russo Partners, LLC+1 (646) 942-5604[email protected]

伊格纳西奥·格雷罗·罗斯博士。D、 Russo Partners，LLC+1（646）942-5604[受电子邮件保护]

1.  Dobson GP. Trauma of major surgery. Int J Surg. 2020 Sep; 81:47-54.

Dobson GP大手术创伤。国际外科杂志，2020年9月；81:47-54。

SOURCE Halia Therapeutics

来源Halia Therapeutics