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Soligenix Kickstarts Dusquetide Mid-Stage Study For Patients With Inflamed Blood Vessels

Soligenix Kickstarts Dusquetide Mid-Stage Study For Patients With Inflamed Blood Vessels

Soligenix启动Dusquetide中期研究,用于患有发炎血管的患者
Benzinga ·  11/14 07:15

On Thursday, Soligenix Inc. (NASDAQ:SNGX) opened patient enrollment for its DUS-AUBD-01 Phase 2 study evaluating SGX945 (dusquetide) for Behçet's Disease, an inflammatory disorder of the blood vessels (vasculitis).

周四,soligenix, inc.(纳斯达克:SNGX)开启了其DUS-AUBD-01第二阶段研究的患者招募,该研究评估SGX945(dusquetide)用于贝赫切特病,这是一种血管的炎症疾病(血管炎)。

The company looks forward to completing enrollment and announcing study results in the first half of 2025.

该公司期待在2025年上半年完成招募并宣布研究结果。

The pilot clinical trial of SGX945 will be an open-label study that will enroll approximately 25 patients aged 18 years or older with mild to moderate Behçet's Disease and active oral and/or genital ulcers.

SGX945的临床试验将是一项开放标签研究,预计招募约25名年龄在18岁或以上的轻度至中度贝赫切特病患者,以及活跃的口腔和/或生殖器溃疡。

Patients will receive SGX945 as a twice-weekly 4-minute intravenous (IV) infusion for 4 weeks, followed by 4 weeks of follow-up.

患者将接受SGX945,每周两次,静脉注射(IV)4分钟,持续4周,随后进行4周的随访。

Efficacy endpoints will include the extent of lesion clearance, timeline to lesion clearance, and patient reported quality of life assessments.

疗效终点将包括病灶清除的程度、病灶清除的时间表和患者报告的生活质量评估。

Dusquetide, the active ingredient in SGX945 (Behçet's Disease) and SGX942 (oral mucositis), is an innate defense regulator (IDR), a new class of short, synthetic peptides.

Dusquetide是SGX945(贝赫切特病)和SGX942(口腔粘膜炎)的活性成分,是一种先天免疫调节剂(IDR),是一类新的短链合成肽。

Dusquetide has demonstrated safety and tolerability in a Phase 1 study in 84 healthy human volunteers.

Dusquetide在84名健康人参与的第一阶段研究中表现出了安全性和耐受性。

In Phase 2 and 3 clinical studies with dusquetide in over 350 subjects with oral mucositis due to chemoradiation therapy for head and neck cancer, positive efficacy results were demonstrated, including potential long-term ancillary benefits.

在对超过350名因头颈癌接受化放疗而出现口腔粘膜炎的受试者进行的第二和第三阶段临床研究中,dusquetide展示了积极的疗效结果,包括潜在的长期附带益处。

There are approximately 18,000 known cases of Behçet's Disease in the U.S., 350,000 in Turkey, and over 50,000 in Europe. There are as many as 1 million people worldwide living with Behçet's Disease.

在美国大约有18,000例已知的白塞病病例,在土耳其有350,000例,在欧洲有超过50,000例。全球生活在白塞病患者中可能有100万人。

In July, The Princeton, New Jersey-based company announced an interim update on the open-label, investigator-initiated study (IIS) evaluating extended Hybryte treatment for up to 12 months in patients with early-stage cutaneous T-cell lymphoma (CTCL).

在7月份,这家位于新泽西州普林斯顿的公司宣布了对开放标签的、研究者发起的研究(IIS)的中期更新,该研究评估了对早期皮肤T细胞淋巴瘤(CTCL)患者的延长Hybryte治疗,时间长达12个月。

Patients have responded positively to HyBryte therapy. Three of the four subjects who have completed at least 12 weeks of therapy already achieved "Treatment Success."

患者对Hybryte治疗反应积极。在完成至少12周治疗的四名受试者中,有三名已经达到了“治疗成功”。

Price Action: At the last check on Thursday, SNGX stock traded higher by 1.10% to $3.67 premarket.

价格动态:周四最后检查时,SNGX股票在盘前交易中上涨了1.10%,至3.67美元。

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