A Comparative study to evaluate the efficacy and safety of topical Luliconazole versus topical Ciclopirox olamine among patients with Tinea corporis/cruris - NIL

开始日期2024-03-16

申办/合作机构

Pradeep & Co.

CTRI/2023/01/049161 / Active, not recruiting临床3期IIT

A randomized study to evaluate and compare the efficacy of emollient versus topical luliconazole in the maintenance of remission of recurrent dermatophytosis after adequate systemic treatment.

开始日期2023-01-26

申办/合作机构-

100 项与卢立康唑相关的临床结果

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100 项与卢立康唑相关的转化医学

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100 项与卢立康唑相关的专利（医药）

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195

项与卢立康唑相关的文献（医药）

2024-11-01·Current drug research reviews

Assessing the Efficacy of Berberine Hydrochloride-loaded Transethosomal Gel System in Treating Dermatophytosis Caused by Trichophyton rubrum in ex-vivo, in-vitro and in-vivo Models

Article

作者: Mishra, Koushlesh Kumar ; Tiwari, Abhishek ; Singh, Sunil ; Kaur, Chanchal Deep ; Sharma, Ajay ; Tiwari, Varsha

Background::

Dermatophytosis is the most common dermatological disorder worldwide. Many drugs are available in the market for the treatment of dermatophytosis, but they have had limited success due to the stratum corneum barrier, antifungal resistance, drug permeation, drug retention in skin layers, etc. Thus, there is a constant need for new topical compounds that are effective against dermatophytosis. Berberine-hydrochloride is an attractive candidate to become an antifungal drug, and by using nanotechnology, it achieves deeper penetration in skin layers with enhanced permeability through the stratum corneum.

Methods::

In this study, we developed an oleic acid-containing berberine-hydrochloride-loaded transethosomal gel for effective treatment of dermatophytosis by Trichophyton rubrum. Berberine- hydrochloride-loaded transethosomal gels were fabricated using the hot homogenization method, followed by the incorporation of transethosomes into the gel-based system using carbopol 934. Transethosomal gel was characterized by physicochemical properties, in vitro drug release, ex-vivo permeation studies, CLSM visualization, antifungal activity, histopathological evaluation, and dermatokinetic study.

Results::

Berberine-hydrochloride-loaded transethosomes seemed to be spherical and found in a range between 200-300 nm. Berberine-hydrochloride-loaded transethosomal gel formulation also exhibited controlled ex-vivo permeation of berberine-hydrochloride over 24 hr through excised rat skin, and CLSM confirmed deeper penetration into skin layers. The in vivo study revealed that transethosomal gel had a healing effect on the skin of Wistar rats infected with Trichophyton rubrum and was better than luliconazole cream. The histopathological evaluation confirmed its safety, and the dermatokinetic study showed transethosomal gel superiority over marketed cream.

Conclusion::

Therefore, the incorporation of berberine hydrochloride-loaded transethosomal nanosystems into the gel has the potential to enhance antifungal activity and permeation through transdermal drug delivery.

2024-10-18·Cureus Journal of Medical Science

Deep Dermal Dilemma: A Case Report on Majocchi’s Granuloma After Topical Steroid Use

Article

作者: Cinna T Durai, Priya ; Veerakumar, Renuka Devi ; Narasimhan, Murali ; Murthy, Aravind Baskar

Majocchi's granuloma represents a unique dermatological entity characterized by the invasion of dermatophytes into the dermis and subcutaneous tissue, typically following trauma or topical corticosteroids, most commonly caused by Trichophyton rubrum. The unrestrained use of over-the-counter topical steroids has led to the rise of Majocchi's granuloma in the past few years. A 57-year-old male presented with complaints of itchy skin lesions over his right ankle for 20 days. There was a history of over-the-counter topical steroid application, following which the lesions exacerbated. Clinical examination showed multiple ill-defined erythematous nodules, 2-3 cm in size, with serosanguinous discharge associated with right ankle swelling. A single annular hyperpigmented scaly patch was also noted over the right leg below the knee. Potassium hydroxide (KOH) examination was positive for fungal hyphae. Histopathological examination (HPE) of the nodule showed features suggestive of Majocchi's granuloma. Fungal culture was performed, which showed growth of Trichophyton rubrum. The patient was started on oral terbinafine 250 mg once daily and topical luliconazole cream twice daily topical application, which resolved the lesions in three weeks, but the patient was advised to continue the treatment for a total duration of two months.

2024-09-01·Naunyn-Schmiedeberg's archives of pharmacology

Polymeric micelle gel with luliconazole: in vivo efficacy against cutaneous candidiasis in Wistar rats

Article

作者: Narang, Raj Kumar ; Singh, Gurmeet

The objective of this research was focused on the design and development of luliconazole-loaded polymeric micelle hydrogel (LUL-PM-CHG) using quality by design (QbD) principle to improve the penetration and retention of LUL in the skin. The optimization of the formulation involved the utilization of a Box-Behnken design with three factors and three levels. The impact of specific formulation variables, namely the ratio of poloxamer P123 and F127, sonication time, and the quantity of drug, was investigated in terms of particle size, micellar incorporation efficiency, and polydispersity index. The LUL-loaded P123/F127 mixed micelles involved the thin film hydration method for thin preparation. The characteristics of optimized formulation include a particle size of 226 ± 8.52 nm, a polydispersity index (PDI) of 0.153 ± 0.002, a zeta potential (ZP) of 30.15 ± 2.32 mV, and a micellar incorporation efficiency (MIE) of 88.38 ± 3.84%. In vitro release studies indicated a sustained release of LUL-PM-CHG for a duration of up to 8 h. The MIC, GI₅₀, and GI₉₀ of different formulations on Candida albicans were determined using both the microtiter broth dilution method and the plate method and showed that LUL-PM-CHG exhibited the highest antifungal activity compared to the other formulations, with MIC values of 3.25 ± 0.19 ng/mL, GI₅₀ values of 37.11 ± 2.89, and GI₉₀ values of 94.98 ± 3.41 The study also measured the % of inhibition activity and the generation of intracellular reactive oxygen species (ROS) using flow cytometry. LUL-PM-CHG showed the highest percentage of inhibition (75.5%) and ROS production (MFI-140951), indicating its enhanced activity compared to LUL-CHG and LUL. Fungal infection was induced in Wistar rats using immunosuppressant's treatment followed by exposure to C. albicans. Finally, in vivo fungal scaling and histopathological studies indicated a reduction in fungal infection in Wistar rat skin after treatment. The obtained results suggested that LUL-PM can serve as a promising formulation to enhance luliconazole antifungal activity and increase patient compliance.

项与卢立康唑相关的新闻（医药）

2024-08-08

·药通社

高迈药业——专注于外用药的药学研发 | CMC-China博览会展商速递

公司介绍苏州高迈药业有限公司成立于2018年，位于苏州工业园区纳米园；专注于外用药的药学研发（乳膏，软膏，凝胶，外用溶液，贴剂）；团队由日本的技术、生产人员领衔，国内知名高校教授为顾问团队；核心管理人员均具有多年的研发管理经验；目前已有1个外用药项目获批；4个已经申报受理项目；2024年计划申报12个项目。公司致力于“高端仿制”“改良型新药”“自主创新药”三步走战略，打造专业外用药“第一股”。项目清单乳膏/软膏/凝胶类1、利丙双卡因乳膏(已获批)11、维氟醌乳膏(氟轻松氢醌维A酸乳膏)21、磷酸芦可替尼乳膏31、复方多粘菌素B软膏2、阿达帕林凝胶(已注册申报)12、尿素乳膏22、复方倍他米松樟脑乳膏32、盐酸丁卡因凝胶3、夫西地酸乳膏(已注册申报)13、盐酸特比萘芬乳膏23、曲咪新乳膏33、壬二酸凝胶4、过氧苯甲酰凝胶(已注册申报)14、卢立康唑乳膏24、多磺酸粘多糖乳膏34、酮洛芬凝胶5、阿达帕林过氧苯甲凝胶(已注册申报)15、曲安奈德益康唑乳膏25、氟维司群乳膏35、雌二醇凝胶6、盐酸阿莫罗芬乳膏16、布洛芬乳膏26、克霉唑阴道乳膏36、黄体酮阴道缓释凝胶7、硝酸咪康唑乳膏17、阿昔洛韦氢化可的松乳膏27、莫匹罗星软膏37、盐酸利多卡因凝胶8、利多卡因丁卡因乳膏18、氢醌乳膏28、克立硼罗软膏38、硝呋太尔制霉菌素阴道软膏9、克拉司酮乳膏19、糠酸莫米松乳膏29、双唑泰乳膏10、伊维菌素乳膏20、丙酸氟替卡松乳膏30、卡泊三醇软膏贴剂1、利多卡因凝胶贴膏4、双氯芬酸依泊胺贴7、双氯芬酸二乙胺乳胶剂10、美沙拉嗪栓2、双氯芬酸钠贴剂5、洛索洛芬钠凝胶贴膏8、妥洛特罗贴剂11、奥昔布宁透皮贴剂3、氟比洛芬凝胶贴膏6、洛索洛芬钠贴剂9、雌二醇贴片 // 其他 1、非那雄胺喷雾剂 2、盐酸阿莫罗芬搽剂 3、联苯苄唑溶液 4、盐酸特比萘芬喷雾剂 5、盐酸特比萘芬涂膜剂 6、硝酸益康唑气雾剂 7、西甲硅油乳剂 8、利多卡因丙胺卡因气雾剂 9、艾氟康唑外用溶液 10、利多卡因喷雾剂 11、盐酸氨酮戊酸外用散 *绿色标色已经获批 *浅绿色表示已经申报设备及资质联系我们联系人：曹总13861331380 ↓↓扫描下方二维码免费报名

临床申请

2024-05-26

·药明康德

不用吃药，自身免疫疾病患者实现长期缓解；总生存率100%的细胞疗法…… | 一周盘点

▎药明康德内容团队编辑本期看点1. Dyne Therapeutics公司治疗杜氏肌营养不良（DMD）等肌肉疾病的潜在“first-in-class”抗体偶联反义寡核苷酸（ASO）疗法的早期临床试验数据积极，可改善患者的肌肉功能。2. 在Orca Bio公司的在研同种异体T细胞免疫疗法Orca-T治疗急性髓系白血病（AML）的1期研究中，患者的一年总生存率达100%。3. iCell Gene Therapeutics公司的BCMA与CD19靶向复合嵌合抗原受体-T（BCMA-CD19 cCAR-T）细胞免疫疗法在早期临床试验中使系统性红斑狼疮（SLE）患者实现了长期无药物缓解。药明康德内容团队整理DYNE-101、DYNE-251：公布1/2期临床试验数据Dyne Therapeutics公司公布了分别用于治疗强直性肌营养不良1型（DM1）和DMD的抗体偶联ASO疗法DYNE-101和DYNE-251的积极1/2期临床试验结果。DYNE-101由与片段抗体（Fab）偶联的反义寡核苷酸组成，Fab与肌肉上高表达的转铁蛋白受体1（TfR1）结合。它旨在实现靶向肌肉组织递送，目的是减少细胞核中的有毒DMPK RNA、释放剪接蛋白、允许正常mRNA处理和正常蛋白翻译，并有可能阻止或逆转疾病进展。在1/2期临床试验ACHIEVE中，DYNE-101（5.4 mg/kg）在第3个月时表现出剂量依赖性剪接校正，剪接校正比例达到27%。此外，DYNE-101改善了患者的肌肉强直、肌肉力量以及多种患者报告的功能性和疲惫指标。DYNE-251由Fab偶联的磷酸二酰胺吗啉寡聚物（PMO）组成。它旨在实现靶向肌肉组织递送，促进外显子51跳跃，使肌肉细胞产生截短、功能性的抗肌萎缩蛋白（dystrophin），目标是停止或逆转疾病进展。在1/2期临床试验DELIVER中，DYNE-251（10 mg/kg）在6个月时将抗肌萎缩蛋白的表达水平提高到接受标准治疗患者的10倍。多种功能性检测也显示出接受DYNE-251治疗患者的功能改善。Orca-T：公布1b期临床试验数据 Orca Bio公司公布了其在研同种异体T细胞免疫疗法Orca-T用于治疗AML患者的1b期临床试验的积极结果。这款细胞疗法由富集的CD34+干细胞，以及通过高精度平台纯化、取材自单倍体匹配供体的特定T细胞亚群组合而成。Orca-Q有潜力改善患者的预后和降低移植物抗宿主疾病（GvHD）风险，并且无需对无法找到人类白细胞抗原（HLA）匹配的患者进行移植后环磷酰胺（PTCy）治疗。此次公布的结果显示，接受Orca-T治疗的37例AML患者中，12个月的无复发生存率和总生存率分别为82.5%和100%，12个月的非复发死亡率为0%。Orca-T在该亚组中的安全性与更大范围的1b期人群一致，没有发现新的安全性信号。Orca-T目前正在美国各大治疗中心进行关键性的3期临床试验评估。BCMA-CD19 cCAR-T：公布1期临床试验数据 iCell Gene Therapeutics宣布其BCMA-CD19 cCAR-T细胞免疫疗法的研究者发起临床试验（IIT）的积极结果。这款由iCell所设计的cCAR-T细胞免疫疗法，在单一结构中表达两种不同且功能齐全的CAR分子，一种靶向B细胞上的CD19分子，另一种靶向浆细胞上的BCMA。鉴于B细胞和长寿浆细胞具有独立的记忆，因此需要同时靶向B细胞和长寿浆细胞以消除所有升高的自身抗体。分析显示，所有接受足量初始剂量cCAR-T治疗的SLE/狼疮性肾炎（LN）患者，在治疗3个月后体内自身抗体呈现阴性，并在随访46个月时，均达到无症状和无药物缓解。ARO-RAGE：公布1/2期临床试验数据Arrowhead Pharmaceuticals公司公布了其用于治疗哮喘等肺部炎症性疾病的RNA干扰（RNAi）疗法ARO-RAGE的最新中期临床数据。高级糖化终产物受体（RAGE）是2型和非2型炎症级联的上游介质，与哮喘和多种炎症疾病的发病机制有关。ARO-RAGE通过RNAi抑制RAGE表达，旨在减少肺上皮细胞中RAGE蛋白的表达，从而有望减少RAGE依赖性炎症通路，以达到降低哮喘患者病情恶化的频率并改善其通气的目的。此次公布的中期结果表明，使用ARO-RAGE治疗后，正常健康受试者（NHV）和轻中度哮喘患者支气管肺泡灌洗液（BALF）和血清中的可溶性RAGE浓度呈剂量依赖性降低。轻度至中度哮喘患者使用两剂ARO-RAGE后，血清中的可溶性RAGE降低了88%，平均最大降幅达77%。此外，该候选疗法的安全性良好，药效学效应持续时间长，有望支持每两个月一次的给药频率。FG-3246：公布1期临床试验的新数据 FibroGen公布了其与Fortis Therapeutics联合开发的潜在“first-in-class”抗体偶联药物（ADC）FG-3246的1期临床试验的新数据。FG-3246旨在治疗转移性去势抵抗性前列腺癌和其他肿瘤类型，其靶向的CD46是一种细胞受体靶点，在前列腺癌和其他肿瘤类型中高度表达，并在大多数正常组织中表达非常有限。FG-3246由抗CD46抗体与抗有丝分裂剂MMAE连接而成，MMAE是一种已经过临床验证的ADC有效载荷。此次公布的结果显示，FG-3246联用恩杂鲁胺使未经生物标志物筛选的患者的中位放射学无进展生存期（PFS）达到10.2个月。此外，FG-3246具有可接受的安全性，不良事件与其他包含细胞毒性药物MMAE作为载荷的ADC一致。TTX-080：公布1b期临床试验数据 Tizona Therapeutics公司公布了其HLA-G靶向抗体TTX-080在转移性结直肠癌（mCRC）和局部晚期/转移性头颈部鳞状细胞癌（mHNSCC）患者中的1b期临床试验数据。TTX-080联用西妥昔单抗对野生型RAS、BRAF、HER2阴性mCRC患者具有抗肿瘤活性，这些患者之前接受过的中位治疗线数为2线（范围为1-5）。患者的中位PFS为24.4周，36周时的无进展生存率为47%。在14例可评估的患者中，4例患者（29%）获得部分缓解（PR），6例患者（43%）保持疾病稳定（SD），这10例（71%）患者的疾病控制了超过90天。TTX-080联用西妥昔单抗可在人乳头瘤病毒（HPV）阴性mHNSCC患者中产生抗肿瘤活性。这些患者之前接受过的中位治疗线数为1线（范围为1-2），所有患者之前都接受过免疫疗法。患者的中位PFS为23.9周，24周时的无进展生存率为43%。在7例可评估的患者中，1例（14%）患者达到了完全缓解（CR），3例（43%）患者达到了PR，1例（14%）患者达到了SD，这5例（71%）患者的疾病控制了超过90天。SON-1010：公布两项1期临床试验的新数据 Sonnet BioTherapeutics公司公布了其在研免疫调节重组蛋白SON-1010的两项1期临床试验的新数据。SON-1010为一重组蛋白，由单链人类IL-12蛋白与和白蛋白结合的抗体单链片段组合而成，具潜力通过刺激产生干扰素γ将像是非小细胞肺癌、黑色素瘤等肿瘤微环境由“冷”转“热”，活化先天免疫与适应性免疫细胞。这些肿瘤的肿瘤微环境中表达SPARC与GP60蛋白。目前，SON-1010研究共招募了61名受试者，患者已接受了25个周期的SON-1010单药治疗或10个周期的SON-1010联用Tecentriq治疗，在任何剂量水平上都未出现剂量限制性毒性。细胞因子数据显示，与重组人IL-12相比，SON-1010的半衰期延长了约10倍，可诱导长时间和可控的干扰素γ反应，且任何剂量下均未发现细胞因子释放综合征的证据。可评估的晚期实体瘤患者中有35%（8/23）在开始给药后的第四个月出现临床获益。Azenosertib：公布1期临床试验数据Zentalis Pharmaceuticals公司公布了新型、选择性口服生物可利用的WEE1抑制剂azenosertib联用吉西他滨治疗复发性或难治性骨肉瘤1期试验的最终结果。WEE1是G1-S和G2-M细胞周期检查点的主调控因子，通过对CDK1和CDK2的负调控来阻止DNA受损细胞的复制。通过抑制WEE1，azenosertib可使细胞周期在存在高水平DNA损伤的情况下继续进行，从而使癌细胞积累DNA损伤并最终死亡。此次公布的结果显示，azenosertib联用吉西他滨的耐受性良好，与过去类似患者人群的队列相比，接受该组合疗法的患者的无事件生存率（EFS）的提高具有临床意义。前者16周的EFS大约为12%，后者18周时的EFS为39%（11/28）。NDI-101150：公布1/2期临床试验数据 Nimbus Therapeutics公司公布了其小分子HPK1抑制剂NDI-101150的早期临床试验的新数据。临床前研究发现，NDI-101150对HPK1的选择性是MAP4K家族相关蛋白的300多倍，这有望减少脱靶效应。此次公布的结果显示，NDI-101150的单药治疗为30例可评估患者中的5例（16.7%）带来了临床获益，包括1例CR（肾细胞癌）、1例PR（肾细胞癌）和3例SD。3名患有胰腺癌、肾细胞癌或子宫内膜癌的患者表现出了长时间（>6个月）的SD，肾细胞癌患者已保持疾病稳定21个月。此外，NDI-101150的耐受性良好，整体安全性可接受。KN-002：公布1b期临床试验数据 Kinaset Therapeutic公司公布了其口腔吸入式泛JAK抑制剂KN-002的1b期研究的积极结果。KN-002是一种对所有JAK亚型（即JAK1、JAK2、JAK3和TYK2）均有效的均衡抑制剂，目前正作为一种非侵入性抗炎治疗药物进行开发，适用于所有接受中高剂量吸入型糖皮质激素（ICS）或长效β2受体激动剂（LABA）维持治疗但病情控制不佳的嗜酸性粒细胞性和非嗜酸性粒细胞性哮喘患者以及慢性阻塞性肺病患者。KN-002配制成干粉，具有出色的递送效率和化学/物理稳定性。通过吸入进行局部给药，KN-002能够在肺部炎症部位达到治疗浓度，同时最大限度地降低全身暴露水平。这项随机、双盲、安慰剂对照研究报告称，在为未接受过吸入皮质类固醇治疗的轻度哮喘患者进行为期10天、每天剂量≤16 mg的治疗后，未发现安全性或耐受性问题。此外，每天使用一次和两次KN-002可在临床上显著降低部分呼出一氧化氮（FeNO）水平。▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放参考资料（可上下滑动查看）[1] GC Biopharma/Novel Pharma's Sanfilippo Syndrome Treatment Obtains FDA IND Approval. 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Retrieved May 24, 2024, from https://www.globenewswire.com/news-release/2024/05/23/2887728/33333/en/Coherus-Presents-Preliminary-Results-from-Phase-I-Dose-Escalation-Study-of-its-Anti-chemokine-receptor-8-CCR8-Antibody-CHS-114-at-the-2024-American-Society-of-Clinical-Oncology-ASC.html[26] AffyImmune Announces Confirmed Complete Response in Patient with Anaplastic Thyroid Cancer. Retrieved May 24, 2024, from https://www.businesswire.com/news/home/20240523653892/en免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

细胞疗法免疫疗法临床结果临床1期信使RNA

2024-04-07

·药明康德

开辟mRNA新应用的蛋白替代疗法；使截肢率降低6倍的糖尿病辅助治疗…… | 一周盘点

▎药明康德内容团队编辑本期看点1. Moderna公司公布了其开发的mRNA蛋白替代疗法mRNA-3927的首个临床试验结果，将mRNA的应用范围扩展到疫苗之外。2. 中度或重度糖尿病足溃疡感染的外用辅助治疗pravibismane在早期临床试验中能够加速缩小溃疡面积，同时使患者与糖尿病溃疡相关的下肢截肢发生率降低了约6倍。药明康德内容团队整理mRNA-3927：公布1/2期临床试验数据Moderna公司在《自然》杂志上发表了其用于治疗丙酸血症（PA）的在研mRNA疗法mRNA-3927的积极早期临床数据。PA是由丙酰辅酶A羧化酶（PCC）的α或β亚基（分别由PCCA和PCCB基因编码）的致病变异引起的，这些变异会导致PCC缺乏，并使有毒的代谢物积累。该病的特点是反复出现的危及生命的代谢失代偿事件（MDE）和多系统并发症。目前，没有针对PA的根本原因的有效治疗方法。mRNA-3927是一种通过静脉给药、由脂质纳米颗粒（LNP）包裹的双mRNA疗法，该疗法编码PCCA和PCCB亚基蛋白以恢复肝脏中功能性PCC酶活性。通过编码细胞内蛋白，mRNA疗法可能在预防和治疗急性代谢失代偿中起作用。此次公布的中期分析显示，mRNA-3927表现出良好的安全性和耐受性，接受mRNA-3927治疗的患者的发病风险降低了70%。研究人员指出，这是首个在罕见疾病患者中，使用mRNA表达细胞内蛋白，作为蛋白替代疗法的临床试验。▲mRNA-3927降低患者出现危及生命的代谢失代偿事件的次数（图片来源：参考资料[16]）Pravibismane：公布1b期临床试验数据Microbion公司公布了其外用候选疗法pravibismane作为中度或重度糖尿病足溃疡感染的辅助治疗的1b期研究结果。Pravibismane具有独特的三重新型作用模式，包括强效广谱抗感染性、抗生物膜活性和免疫调节活性。此次公布的结果显示，pravibismane的耐受性良好，全身吸收率极低，没有出现任何治疗引发的不良反应或严重不良事件。与安慰剂组相比，接受pravibismane治疗的受试者溃疡面积缩小了约3倍（85%对比30%），与糖尿病溃疡相关的下肢截肢发生率降低了约6倍（2.6%对比15.4%）。这些结果表明，局部使用pravibismane有望满足糖尿病溃疡患者的未竟药物需求，这种新疗法可以同时治疗细菌生物膜相关感染并加速缩小溃疡面积，并有可能导致伤口完全再上皮化和闭合，同时降低患者再感染和截肢的风险。Deltacel（KB-GDT-01）：公布1期临床试验中第三例患者的数据Kiromic BioPharma公司公布了其在研γ-δ T细胞（GDT）疗法Deltacel（KB-GDT-01）用于治疗IV期转移性非小细胞肺癌（NSCLC）患者的1期临床试验的积极早期疗效数据。Deltacel是一种同种异体细胞治疗产品，由未经修饰的供体来源GDT组成。Deltacel旨在利用GDT的天然效力靶向实体瘤，最初的临床开发重点是NSCLC（约占肺癌病例的80%至85%）。两项临床前研究的数据表明，Deltacel与低剂量放射治疗相结合具有良好的安全性和有效性。从治疗开始六周后获得的初步结果显示，Deltacel在控制肿瘤生长方面具有有效性，以及良好的安全性和耐受性。此前公布的首例患者在治疗前三天被确诊为病情进展活跃。接受Deltacel治疗六周后，计算机断层扫描（CT）扫描证实了此患者的病情稳定，初步的无进展生存期为一个半月。第二例患者在治疗开始前进行了核磁共振（MRI）扫描，发现了新的转移灶，这些新病灶在治疗后第六周的MRI复查中被发现已完全消退。此次公布的第三例患者在入组时疾病处于活动期，接受治疗后的第六周时，PET/CT、诊断CT和MRI扫描结果均显示患者的疾病正趋于稳定，没有出现新的转移性疾病。cNeT：公布1/2a期临床试验的中期数据Achilles Therapeutics公司公布了关于克隆性新抗原反应性T细胞（cNeT）在晚期不可切除或转移性NSCLC患者中、以及在复发性或转移性恶性黑色素瘤患者中的早期临床试验的中期数据。此次公布的数据显示，25%（3/12）的高剂量组患者达到疾病稳定（SD）状态，肿瘤体积有所缩小。而因为与IL-2相关的毒性更少，cNeT的安全性和耐受性与标准的肿瘤浸润淋巴细胞疗法相比更有优势。FG-3246：公布1期临床试验数据FibroGen公布了其与Fortis Therapeutics联合开发的潜在“first-in-class”抗体偶联药物（ADC）FG-3246（亦称FOR46）在1期临床试验中获得积极顶线数据。FG-3246旨在治疗转移性去势抵抗性前列腺癌和其他肿瘤类型，其靶向的CD46是一种细胞受体靶点，在前列腺癌和其他肿瘤类型中高度表达，并在大多数正常组织中表达非常有限。FG-3246由抗CD46抗体与抗有丝分裂剂MMAE连接而成，MMAE是一种已经过临床验证的ADC有效载荷。此次公布的结果显示，36%可评估前列腺特异性抗原（PSA）的患者被观察到PSA减少超过50%（PSA50）。对于可根据RECIST评估的患者，20%达到部分缓解（PR），定义为肿瘤缩小超过30%，中位缓解持续时间为7.5个月。在这批接受大量前期治疗的患者中，中位放射学无进展生存期（rPFS）为8.7个月。最常见的不良事件与其他包含细胞毒性药物MMAE作为载荷的ADCs一致，包括输液相关反应、疲劳、体重减轻、中性粒细胞减少和周围神经病变。Itolizumab：公布1b期临床试验数据Equillium公司公布了其在研单克隆抗体itolizumab治疗狼疮性肾炎的1b期临床试验的积极顶线数据。Itolizumab是一种潜在“first-in-class”的CD6靶向单克隆抗体，可选择性靶向CD6-ALCAM信号通路，选择性抑制致病性效应T细胞，同时保留对维持平衡免疫反应至关重要的调节T细胞。T细胞可驱动多种免疫炎症疾病，该通路在调节T细胞的活性和运输方面发挥着核心作用。此次公布的结果显示，当itolizumab联合吗替麦考酚酯/霉酚酸（MMF/MPA）和皮质类固醇使用时，与标准治疗方法相比，患者达成完全缓解（CR）和PR的比例更高，且尿蛋白肌酐比值（UPCR）的降低更为迅速和显著。大多数治疗伴发不良反应（TEAE）的严重程度被评估为轻度（1级）或中度（2级），其中两种最常见的TEAE是淋巴细胞减少和外周水肿。CONV01-α：公布1/2期临床试验数据Convergent Therapeutics的主打在研疗法CONV01-α是一种与锕-225（Ac-225）结合的单克隆抗体，靶向前列腺特异性膜抗原（PSMA）。锕-225是一种放射性α粒子发射器。CONV01-α的一个关键功能特性是，一旦与PSMA结合，它就会被内化，将其强大的放射性有效成分直接送入前列腺癌细胞，同时将对周围健康组织的损害降至最低。新闻稿指出，CONV01-α有望成为首个获批用于前列腺癌治疗的Ac-225放射性抗体。在一项针对晚期前列腺癌患者的多剂量、剂量递增研究中，患者对CONV01-α的耐受性良好，67%的患者达到了PSA50，27%的患者被观察到PSA减少超过90%（PSA90）。正在进行的研究表明，CONV01-α在单独使用或与其他癌症疗法联合使用时可能非常有效。TPST-1120：公布1期临床试验数据Tempest Therapeutics公司公布了其在研疗法TPST-1120单药或联用纳武利尤单抗治疗晚期实体瘤的1期试验的积极结果。TPST-1120是一种口服、选择性PPARα小分子拮抗剂。临床前数据显示，TPST-1120可直接杀死肿瘤细胞，并靶向肿瘤微环境中的抑制性免疫通路。这两种类型中的靶向细胞皆依赖脂肪酸代谢，该代谢过程由PPARα转录因子调节。在一项针对接受过多次治疗的晚期实体瘤患者的1期临床试验中，TPST-1120单药治疗和与PD-1抑制剂纳武利尤单抗联合应用均导致肿瘤缩小及生物标志物的变化。此次公布的临床数据显示，TPST-1120单药或联用纳武利尤单抗的耐受性良好，最大耐受剂量尚未确定。在接受单药治疗的患者中，53%（10/19）可评估患者的最佳缓解是SD，其中5名患者的治疗时间超过5个月。21%的患者（4例）在接受治疗后靶病灶缩小，另有3例患者的最佳缓解是靶病灶无生长。在此前接受过多线治疗的胆管癌（CCA）、肝细胞癌（HCC）和肾细胞癌（RCC）患者的联合治疗队列中，所有剂量水平的客观缓解率（ORR）为23%（3/13，均为PR）。在曾接受过抗PD-1治疗并疾病进展的RCC和CCA患者中，ORR为50%（2/4）。全血标本分析显示，PPARα相关免疫基因的表达与TPST-1120的剂量水平有关。其中一些变化仅在部分获得缓解的患者中观察到，这说明TPST-1120的生物活性与患者的临床结局有关。SZN-043：公布1a期临床试验数据Surrozen公司公布了SZN-043在健康受试者和肝硬化患者中进行的1a期临床试验的最新进展。SZN-043是采用Surrozen的SWEETS技术开发的首个候选药物，旨在治疗严重肝病。在这项研究中，SZN-043在所有受试者中均表现出了可接受的安全性和耐受性。在有肝病史的肝硬化患者中，SZN-043能够呈剂量依赖性地激活Wnt信号转导，并改善患者的肝功能。ELI-002：公布1期临床试验的新数据Elicio Therapeutics公司公布了其在研治疗性癌症免疫疗法ELI-002治疗具高复发风险胰腺癌和结直肠癌患者的新临床试验数据，这些患者携带KRAS G12D和G12R突变。ELI-002由AMP修饰的KRAS突变体（mKRAS）肽段，和一种AMP修饰的免疫刺激寡核苷酸佐剂ELI-004组成，经皮下给药靶向淋巴结。它能产生RAS特异性杀伤性T细胞，以攻击术后残留肿瘤细胞，有望延长癌症患者缓解并可预防未来复发。此次公布的结果显示，68%接受ELI-002治疗的患者产生了细胞毒性mKRAS特异性CD4+T细胞；84%的患者产生了细胞毒性mKRAS特异性CD8+T细胞；大多数接受ELI-002治疗的患者都出现了抗原扩散，诱导的T细胞靶向mKRAS以外的其他患者特异性肿瘤突变；在大多数接受ELI-002加强剂量治疗的患者中观察到持久的mKRAS特异性T细胞应答，记忆T细胞表型增加。大家都在看药明康德为全球生物医药行业提供一体化、端到端的新药研发和生产服务，服务范围涵盖化学药研发和生产、生物学研究、临床前测试和临床试验研发、细胞及基因疗法研发、测试和生产等领域。如您有相关业务需求，欢迎点击下方图片填写具体信息。▲如您有任何业务需求，请长按扫描上方二维码，或点击文末“阅读原文/Read more”，即可访问业务对接平台，填写业务需求信息▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放参考资料（可上下滑动查看）[1] Hanmi Pharm submits IND to US FDA for obesity drug HM15275 phase 1 trial. Retrieved April 7, 2024, from https://www.koreabiomed.com/news/articleView.html?idxno=23719[2] Equillium Announces Positive Topline Data from the Type B Portion of the Phase 1b EQUALISE Study of Itolizumab in Lupus Nephritis. Retrieved April 7, 2024, from https://www.businesswire.com/news/home/20240401373328/en[3] Context Therapeutics Submits IND Application to Evaluate CTIM-76 in Claudin 6-Positive Cancers. Retrieved April 7, 2024, from https://www.globenewswire.com/news-release/2024/04/01/2855097/0/en/Context-Therapeutics-Submits-IND-Application-to-Evaluate-CTIM-76-in-Claudin-6-Positive-Cancers.html[4] FibroGen Announces Topline Results from Phase 1 Monotherapy Study of FG-3246 in Patients with Metastatic Castration-Resistant Prostate Cancer. Retrieved April 7, 2024, from https://www.globenewswire.com/news-release/2024/04/02/2856521/33525/en/FibroGen-Announces-Topline-Results-from-Phase-1-Monotherapy-Study-of-FG-3246-in-Patients-with-Metastatic-Castration-Resistant-Prostate-Cancer.html[5] Convergent Therapeutics Announces FDA Clearance of IND Application for CONV01-α, a Best-in-Class Radioantibody Targeting Prostate-Specific Membrane Antigen. Retrieved April 7, 2024, from https://www.prnewswire.com/news-releases/convergent-therapeutics-announces-fda-clearance-of-ind-application-for-conv01--a-best-in-class-radioantibody-targeting-prostate-specific-membrane-antigen-302106271.html[6] Caribou Biosciences Expands Clinical Development of CB-010 with FDA Clearance of IND in Lupus. 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Retrieved April 7, 2024, from https://investors.surrozen.com/news-releases/news-release-details/surrozen-announces-safety-pharmacodynamic-and-liver-function[16] Koeberl et al., (2024). Interim analyses of a first-in-human phase 1/2 mRNA trial for propionic acidaemia. Nature, https://doi.org/10.1038/s41586-024-07266-7免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

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适应症	国家/地区	公司	日期
手癣	美国	Bausch Health US LLC	2018-02-20
甲癣	日本	Sato Pharmaceutical Co., Ltd.	2016-01-22
皮肤念珠菌病	中国	海南海灵化学制药有限公司	2012-06-27
真菌病	韩国	Dream Pharma Corp.	2010-02-01
体癣	日本	Nihon Nohyaku Co., Ltd.	2005-07-31
股癣	日本	Nihon Nohyaku Co., Ltd.	2005-07-31
足癣	日本	Nihon Nohyaku Co., Ltd.	2005-07-31
念珠菌病	日本	Sun Pharma Japan Ltd.	2005-04-11
癣	日本	Sun Pharma Japan Ltd.	2005-04-11
花斑癣	日本	Sun Pharma Japan Ltd.	2005-04-11

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适应症	最高研发状态	国家/地区	公司	日期
慢性皮肤黏膜念珠菌病	药物发现	美国	Topica Pharmaceuticals, Inc.	2011-01-11

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02767947 (CTgov)	临床4期	体癣	75	Luliconazole Cream 1% (Luliconazole Cream 1%)	簾襯顧簾鹽糧構夢膚鹽(壓繭衊選獵窪願餘蓋艱) = 簾鹹構簾鹹夢網糧選憲鏇鏇廠壓願鬱窪鬱顧廠 (餘網鬱餘壓願衊齋鹹繭, 淵觸醖繭選製積鏇餘鑰 ~ 淵鹽願築鹽網觸襯願選) 更多	-	2019-11-27
				Vehicle Cream (Vehicle Cream)	簾襯顧簾鹽糧構夢膚鹽(壓繭衊選獵窪願餘蓋艱) = 構製衊觸憲願願醖膚製鏇鏇廠壓願鬱窪鬱顧廠 (餘網鬱餘壓願衊齋鹹繭, 簾網衊構選夢築憲衊網 ~ 蓋網壓遞繭衊遞製構淵) 更多
NCT02394340 (CTgov)	临床4期	股癣 \| 足癣	20	Omeprazole 40 mg+Luliconazole Cream 1%	鏇獵鹽衊醖鑰鬱衊範鏇(選網範壓糧鑰艱構獵範) = 鏇憲蓋齋構壓構網憲鏇餘遞廠衊齋簾構積觸艱 (選遞鹽鹹壓齋觸鬱衊齋, 製範獵醖齋簾鏇簾糧廠 ~ 窪遞網膚憲鹹築膚構廠) 更多	-	2019-11-27
NCT02767271 (CTgov)	临床4期	股癣 \| 足癣	30	Luliconazole Cream 1% (Tinea Pedis)	鹹願觸鏇範選製觸壓積(願壓糧夢顧鹹繭選壓獵) = 膚鏇鬱鹹糧構憲窪鬱鑰醖糧廠積襯窪繭顧選蓋 (衊願製積簾醖鏇遞鑰願, 廠願鬱構選憲繭願簾鹽 ~ 簾範構構醖齋選顧膚齋) 更多	-	2019-11-27
				Luliconazole Cream 1% (Tinea Cruris)	艱餘鏇窪構鏇鏇鹹醖襯(齋窪願製遞鏇範鹹夢憲) = 淵艱壓齋鹽鏇鑰壓餘蓋齋壓壓網醖淵鏇鹹淵艱 (齋窪鹽餘鬱繭膚鏇壓範, 鹹廠範壓選壓構遞壓鏇 ~ 積積繭艱糧選積艱網範) 更多