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MannKind Shares Fall After Completing Initial Stage Lung Disease Study
MannKind Shares Fall After Completing Initial Stage Lung Disease Study
MannKind Corporation (NASDAQ:MNKD) has successfully completed a Phase 1 study of clofazimine inhalation suspension (MNKD 101), an inhalation treatment option for nontuberculous mycobacterial (NTM) lung disease.
The Phase I clinical trial is a single- (SAD) and multiple-ascending dose (MAD) study to evaluate the safety, tolerability, and pharmacokinetics (PK) of MNKD-101 in healthy volunteers.
In the single-ascending dose (SAD) portion of the study, 24 adults were enrolled in one of three cohorts (n = 8 per cohort) that received a single inhaled dose of 30 mg, 60 mg or 90 mg clofazimine.
During the multiple-ascending dose (MAD) portion of the study, 16 adults were enrolled in one of two cohorts (n = 8 per cohort) that received a daily inhaled dose of 30 mg or 90 mg clofazimine for a seven-day period.
Michael Castagna, Chief Executive Office, commented: "There is a high unmet need to develop medicines that are well tolerated and effective in alleviating symptoms for those living with NTM lung disease. As we continue to expand our orphan lung diseases focus at MannKind, we are encouraged by what we are seeing with inhaled clofazimine and the future potential to help patients."
The company is planning discussions with the U.S. Food and Drug Administration (FDA) regarding results and the ongoing clinical program.
MannKind anticipates to share detailed data readouts in upcoming publications and scientific conferences.
Nontuberculous mycobacteria (NTM) lung disease is a serious infection that is caused by bacteria common in the environment that can lead to a reduction in lung function, cough, fatigue, and quality of life.
Price Action : MannKind shares are trading around down 3 percent at $3.69 on Tuesday at the time of publication.
MannKind Corporation (NASDAQ:MNKD) has successfully completed a Phase 1 study of clofazimine inhalation suspension (MNKD 101), an inhalation treatment option for nontuberculous mycobacterial (NTM) lung disease.
曼肯德公司(纳斯达克代码:MNKD)已经成功地完成了氯法齐明吸入混悬剂(MNKD101)的第一阶段研究,这是一种治疗非结核分枝杆菌肺部疾病的吸入疗法。
The Phase I clinical trial is a single- (SAD) and multiple-ascending dose (MAD) study to evaluate the safety, tolerability, and pharmacokinetics (PK) of MNKD-101 in healthy volunteers.
I期临床试验是一项单次(SAD)和多次递增剂量(MAD)研究,旨在评估MNKD-101在健康志愿者中的安全性、耐受性和药代动力学(PK)。
In the single-ascending dose (SAD) portion of the study, 24 adults were enrolled in one of three cohorts (n = 8 per cohort) that received a single inhaled dose of 30 mg, 60 mg or 90 mg clofazimine.
在这项研究的单次递增剂量(SAD)部分,24名成年人被纳入三个队列中的一个(每个队列n=8),接受单次吸入剂量30 mg、60 mg或90 mg的氯法齐明。
During the multiple-ascending dose (MAD) portion of the study, 16 adults were enrolled in one of two cohorts (n = 8 per cohort) that received a daily inhaled dose of 30 mg or 90 mg clofazimine for a seven-day period.
在研究的多重递增剂量(MAD)部分,16名成年人被纳入两个队列中的一个(每个队列8个),每天接受30毫克或90毫克氯法齐明的吸入剂量,为期7天。
Michael Castagna, Chief Executive Office, commented: "There is a high unmet need to develop medicines that are well tolerated and effective in alleviating symptoms for those living with NTM lung disease. As we continue to expand our orphan lung diseases focus at MannKind, we are encouraged by what we are seeing with inhaled clofazimine and the future potential to help patients."
首席执行官迈克尔·卡斯塔尼亚评论说:“人们迫切需要开发耐受性好、能有效缓解NTM肺部疾病患者症状的药物。随着我们在MannKind继续扩大我们对孤儿肺部疾病的关注,我们对吸入氯法齐明的情况以及未来帮助患者的潜力感到鼓舞。”
The company is planning discussions with the U.S. Food and Drug Administration (FDA) regarding results and the ongoing clinical program.
该公司正计划与美国食品和药物管理局(FDA)就结果和正在进行的临床计划进行讨论。
MannKind anticipates to share detailed data readouts in upcoming publications and scientific conferences.
MannKind预计将在即将到来的出版物和科学会议上分享详细的数据读数。
Nontuberculous mycobacteria (NTM) lung disease is a serious infection that is caused by bacteria common in the environment that can lead to a reduction in lung function, cough, fatigue, and quality of life.
非结核分枝杆菌(NTM)肺部疾病是一种严重的感染,由环境中常见的细菌引起,可导致肺功能下降、咳嗽、疲劳和生活质量。
Price Action : MannKind shares are trading around down 3 percent at $3.69 on Tuesday at the time of publication.
价格行动:截至周二,MannKind的股价下跌约3%,至3.69美元。
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