BOSTON--(BUSINESS WIRE)--DermBiont, a clinical-stage biotechnology company that is advancing first-in-class topical therapeutics to address patient needs in rare disease oncology and aesthetic dermatology, today announced positive initial data from its ongoing open label, multi-center Phase 2a study for the treatment of basal cell carcinoma (BCC).

波士顿--（商业新闻短讯）--DermBiont是一家临床阶段生物技术公司，正在推进一流的局部治疗方法，以解决罕见疾病肿瘤学和美容皮肤病学的患者需求，今天宣布了其正在进行的开放标签，多中心2a期研究的积极初步数据，用于治疗基底细胞癌（BCC）。

As a result, DermBiont has reprioritized SM-020, a first-in-class, patient-applied, and topical kinase inhibitor, for the development of two lead orphan disease oncology indications: treatment of locally advanced basal cell carcinoma (laBCC) and prevention of BCC in Gorlin Syndrome patients..

因此，DermBiont重新确定了SM-020的优先级，SM-020是一流的患者应用的局部激酶抑制剂，用于开发两种主要的孤儿疾病肿瘤学适应症：治疗局部晚期基底细胞癌（laBCC）和预防戈林综合征患者的BCC。。

DermBiont’s Phase 2a open-label trial is actively enrolling and treating up to 30 subjects with one to five superficial, nodular, or infiltrating primary BCCs. Lesions are being treated with SM-020 1% gel BID (twice daily) for 28 days, with the primary endpoint based on percent change from baseline in greatest tumor diameter at week 6.

DermBiont的2a期开放标签试验正在积极招募和治疗多达30名患有1至5个浅表，结节或浸润性原发性BCC的受试者。。

The safety of the drug product is being evaluated based on frequency of adverse events (AEs) and application site reactions (ASRs)..

正在根据不良事件（AE）和应用部位反应（ASR）的频率评估药品的安全性。。

At the time of this release, seven subjects with a total of nine BCCs (1 superficial, 4 nodular, and 4 infiltrating) have been treated and show a prompt (within days of starting treatment) and robust clinical response to the application of SM-020 1% gel, clearly demonstrating the disease modifying potential of SM-020.

在本次发布时，共有9个BCC（1个浅表性，4个结节性和4个浸润性）的7名受试者接受了治疗，并显示出对SM-020 1%凝胶的应用的迅速（在开始治疗的几天内）和强大的临床反应，清楚地证明了SM-020的疾病改善潜力。

All nine tumors have also demonstrated a partial or total reduction in clinically visible tumor..

所有九种肿瘤也显示临床上可见的肿瘤部分或全部减少。。

Dr. Karl Beutner, M.D., Ph.D., and CEO of DermBiont said: “We are excited about these early results in BCC and the potential for a topical product for the treatment of laBCC and the prevention of BCCs in Gorlin Syndrome. An effective topical treatment would be welcomed by patients with laBCC given the limitations and side effects of the currently approved oral hedgehog inhibitors, while also providing patients with Gorlin Syndrome with an alternative to expensive and painful surgical procedures to remove chronic BCCs that result in significant scarring, require post-operative wound care, and lead to significant down time.”.

DermBiont首席执行官Karl Beutner博士说：“我们对BCC的这些早期结果以及用于治疗laBCC和预防Gorlin综合征BCC的局部产品的潜力感到兴奋。鉴于目前批准的口服刺猬抑制剂的局限性和副作用，laBCC患者将欢迎有效的局部治疗，同时也为Gorlin综合征患者提供了昂贵而痛苦的外科手术替代方案，以去除导致严重瘢痕形成的慢性BCC，需要术后伤口护理，并导致显着的停机时间。”。

SM-020 has been well tolerated to date with no drug-related adverse events and only rare and transient primarily mild-to-moderate severity application site reactions. The same drug product has also been shown to be extremely well tolerated by subjects with seborrheic keratoses (SK), having been administered by over 100 subjects with SKs twice daily for at least 28 days in prior clinical trials..

迄今为止，SM-020的耐受性良好，没有药物相关的不良事件，只有罕见和短暂的主要是轻度至中度严重的应用部位反应。在先前的临床试验中，100多名患有脂溢性角化病（SK）的受试者每天两次服用相同的药物，至少28天，同样的药物产品也被证明对脂溢性角化病（SK）的受试者具有极好的耐受性。。

Emma Taylor, M.D. and Chief Medical Officer at DermBiont, added: “SM-020 in vitro is highly potent at killing BCC cells and has a well-defined mechanism of action that hits established tumorigenesis pathways known to be the cause of BCCs, so the robust response that we are seeing in the clinic is not surprising.”.

医学博士兼DermBiont首席医疗官Emma Taylor补充道：“SM-020在体外具有很强的杀伤BCC细胞的能力，并且具有明确的作用机制，可以打击已知是BCC病因的既定肿瘤发生途径，因此我们在临床上看到的强烈反应并不令人惊讶。”。

Basal Cell Carcinoma is the most common cancer with over three million cases annually in the United States alone. A BCC that is at least 10mm in diameter and that has either failed or is not appropriate for conventional treatment is considered a laBCC. In the United States, over 10,000 individuals suffer from laBCC annually, at least 10,000 individuals suffer from Gorlin Syndrome, and more than 30,000 people suffer from high frequency sporadic BCC, with tens of thousands of individuals being diagnosed with multiple basal cell carcinomas annually..

基底细胞癌是最常见的癌症，仅在美国每年就有300多万例。。在美国，每年有10000多人患有laBCC，至少10000人患有Gorlin综合征，30000多人患有高频散发性BCC，每年有数万人被诊断出患有多种基底细胞癌。。

Following the reprioritization of SM-020 for laBCC and Gorlin Syndrome, Dermbiont is evaluating options for its SK program..

继针对laBCC和Gorlin综合征重新确定SM-020的优先级后，Dermbiont正在评估其SK计划的选项。。

About DermBiont

关于DermBiont

DermBiont is a clinical-stage biotechnology company advancing two first-in-class topical therapeutics with well-defined mechanisms of action to address patient needs in rare disease oncology and aesthetic dermatology. SM-020 for the treatment of laBCC and prevention of BCC in Gorlin Syndrome, and SM-030 for the treatment of melasma and other hyperpigmentation disorders of the skin.

DermBiont是一家临床阶段的生物技术公司，推出了两种一流的局部治疗药物，具有明确的作用机制，以满足罕见疾病肿瘤学和美容皮肤病学的患者需求。。