Advancing a new TB drug through early clinical trials

通过早期临床试验推进新的结核病药物

• 批准号: 6845467
• 负责人: Carol A. Nacy
• 金额: $ 136.14万
• 依托单位: SEQUELLA, INC.
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-09-02 至 2006-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6845467
• 关键词: antibacterial agents; bioterrorism /chemical warfare; clinical trial phase I; clinical trial phase II; clinical trials; cooperative study; drug design /synthesis /production; ethambutol; human subject; human therapy evaluation; method development; multidrug resistance; patient oriented research; respiratory disorder chemotherapy; tuberculosis

DESCRIPTION (provided by applicant): This application for a Biodefense Product Development Challenge Grant requests support for the early clinical trials of a new tuberculosis drug. The new drug-SQ109-is effective against multi-drug resistant TB, which is a Category C NIAID high priority pathogen. SQ109 was developed by a small biopharmaceutical company, in collaboration with the NIH. All discovery phase research is completed, and the compound is at the final stage of pre-clinical development. The scope of work proposed would advance SQ109 through the final regulatory requirements for filing an IND, through all of the Phase I safety trials, and through two of the anticipated three Phase II clinical trials. The Phase II clinical trials to be completed will be a seven-day study of SQ109 with early bactericidal activity (EBA) as a key indicator of anti-TB efficacy, and a two-month combination-treatment study with sputum conversion as the primary outcome measure. These studies will position SQ109 for the last stages of clinical development-a final, longer-term Phase II study that will serve as a pilot study for the Phase III clinical trial, and the Phase III clinical trial itself. Development of a new TB drug that is effective against multi-drug resistant TB will have enormous public health benefits and global health impact, as well as providing defense against the possible use of TB as a bio-weapon.

描述（由申请人提供）：本生物融合产品开发挑战的申请赠款请求支持新的结核病药物的早期临床试验。新的药物-SQ109-有效地针对多药耐药结核病，这是C NIAID高优先级病原体。 SQ109是由一家小型生物制药公司与NIH合作开发的。所有发现阶段研究都已完成，并且该化合物正处于临床前开发的最后阶段。提出的工作范围将通过对IND，所有I期安全试验以及预期的三个II期临床试验中的两项提出IND的最终法规要求提高SQ109。要完成的II期临床试验将是对早期杀菌活性（EBA）的SQ109进行的为期7天的研究，作为抗TB疗效的关键指标，以及用痰液转换为主要结果度量的两个月组合治疗研究。这些研究将在临床开发的最后阶段定位SQ109 - 最终的长期II期研究将作为III期临床试验的试点研究，以及III期临床试验本身。开发一种有效抵抗多药结核病的新结核病药物将具有巨大的公共卫生益处和全球健康的影响，并为可能使用TB作为生物武器提供防御。