Quoin Pharmaceuticals Ltd. announces positive interim clinical data from two of its ongoing Netherton Syndrome clinical studies

Quoin Pharmaceuticals Ltd.公布了两项正在进行的Netherton综合征临床研究的积极中期临床数据

Data from the first subject being dosed twice-daily in Quoin’s ongoing open label study is suggestive of clinical efficacy across a number of measured endpoints after six weeks of dosing with QRX 003, which is the midpoint of testing.

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At baseline, prior to dosing, the subject’s Modified Ichthyosis Area of Severity Index (MIASI) was 18. Following six weeks of dosing with QRX 003, the subject’s MIASI had been reduced to 4. In addition, the Investigator’s Global Assessment (IGA) of disease severity prior to dosing classified the subject as ‘moderate’.

在基线时，给药前，受试者的改良鱼鳞病严重程度指数（MIASI）为18。服用QRX 003六周后，受试者的MIASI降至4。此外，研究者在给药前对疾病严重程度的全面评估（IGA）将受试者分类为“中度”。

After six weeks of dosing with QRX 003, the IGA for the subject was classified as ‘mild’. The subject’s pruritus or itch assessment at baseline was 7 out of a maximum of 11 based on the Worst Itch Numeric Rating Scale (WINRS) and was reduced to 4 at the treatment midpoint. Finally, the patient satisfaction scores across assessed metrics were highly positive.

服用QRX 003六周后，受试者的IGA被归类为“轻度”。根据最差瘙痒数字评定量表（WINRS），受试者在基线时的瘙痒或瘙痒评估为11分中的7分，在治疗中点降至4分。最后，评估指标的患者满意度得分非常积极。

No safety concerns were reported for the subject during this initial testing period..

在最初的测试期间，没有报告该受试者的安全问题。。

In addition, after the initial 12 days of dosing in Quoin’s ongoing 12-week Investigator Pediatric Study, a significant improvement was observed in the skin area treated with QRX 003 versus the non-treated area. Specifically, at baseline prior to dosing with QRX 003, the IGA assessment of the subject’s skin was classified as ‘severe’.

此外，在Quoin正在进行的为期12周的研究者儿科研究中，在最初的12天给药后，与未治疗区域相比，用QRX 003治疗的皮肤区域观察到显着改善。具体而言，在服用QRX 003之前的基线时，受试者皮肤的IGA评估被归类为“严重”。

After 12 days of treatment with QRX 003, this was improved to ‘mild-moderate’, representing a very rapid improvement in skin appearance. There have been no adverse events or safety concerns reported to date..

用QRX 003治疗12天后，这一情况改善为“轻度-中度”，代表皮肤外观的快速改善。迄今为止，尚未报告任何不良事件或安全问题。。

Quoin CEO, Dr. Michael Myers, said, “While cautioning that this is interim clinical data from a very limited number of subjects, we are very pleased to announce these early results from two of our ongoing Netherton Syndrome clinical studies. Having previously announced positive data for subjects dosed once-daily for 12 weeks in our ongoing open-label study, we are excited to share initial data for the first subject dosed twice-daily to reach six weeks of dosing in this study.

Quoin首席执行官迈克尔·迈尔斯博士（MichaelMyers）说：“虽然警告说这是来自数量非常有限的受试者的临时临床数据，但我们很高兴宣布我们正在进行的两项Netherton综合征临床研究的这些早期结果。之前在我们正在进行的开放标签研究中宣布了12周内每天服用一次的受试者的阳性数据，我们很高兴分享在这项研究中每天服用两次以达到六周剂量的第一个受试者的初始数据。

Although clear improvements were observed across all four measured endpoints, the reduction in MIASI from 18 at baseline to just 4 after six weeks of dosing with QRX003 is particularly noteworthy. Similarly, the reduction in pruritus severity from 7, out of a maximum of 11, to 4 after six weeks of dosing with QRX 003 is also promising..

尽管在所有四个测量终点均观察到明显的改善，但在服用QRX003六周后，MIASI从基线时的18降至仅4，这一点特别值得注意。同样，在服用QRX 003六周后，瘙痒症的严重程度从最多11例中的7例降低到4例也是有希望的。。

“Furthermore, it is very encouraging to observe such a clear improvement in skin condition in the investigator pediatric study, after just 12 days of being treated with QRX 003. The change from an IGA classification of severe prior to dosing to mild-moderate after such a short period of time is highly encouraging as we seek to recruit additional pediatric subjects in Spain and the United Kingdom.

“此外，在接受QRX 003治疗仅12天后，在研究者儿科研究中观察到皮肤状况明显改善，这是非常令人鼓舞的。由于我们寻求在西班牙和英国招募更多的儿科受试者，因此在如此短的时间内从给药前的IGA严重分类到轻度中度的变化非常令人鼓舞。

We remain steadfast in our commitment to develop a safe and effective treatment for the Netherton Syndrome community.”.

我们仍然坚定地致力于为Netherton综合征社区开发安全有效的治疗方法。”。

Condition: Netherton Syndrome

病情：Netherton综合征

Type: drug

类型：药物