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IND-Enabling Pre-clinical Development of Modified P8 for the Treatment of Alzheimer's Disease

IND 促进修饰 P8 治疗阿尔茨海默病的临床前开发

基本信息

批准号：
10357986
负责人：
NAZNEEN N DEWJI
金额：
$ 10.11万
依托单位：
CENNA BIOSCIENCES, INC.
依托单位国家：
美国
项目类别：
财政年份：
2012
资助国家：
美国
起止时间：
2012-08-15 至 2022-06-30
项目状态：
已结题

项目摘要

Summary The parent Commercialization Readiness Program grant was to conduct studies necessary to support regulatory submissions relating to pre-clinical development of Cenna’s peptide drug candidate mP8. mP8 is being developed as a new, first-in-class peptide drug for the treatment of Alzheimer’s disease. The funded grant builds on the substantial progress made under the previously funded SBIR Phase 2 and 2B grants to carry out activities to support a future first in human clinical study of mP8. A necessary component of the studies that is required by the FDA is to conduct IND-enabling drug safety toxicity and GLP safety pharmacology studies in two species of animals. For peptides, small molecules and other drug modalities, studies using a rodent plus a non-rodent species are required by the FDA to support clinical development and licensing. When the parent grant was submitted, we had proposed to use the cynomolgus monkey as the non-rodent animal model for these studies as it is an accepted species for preclinical toxicity testing and is more closely related, both phylogenetically and physiologically, to humans than dogs. Monkeys are also much smaller than dogs and so would require much less peptide. This is important since our studies to date have indicated that our original peptide P8 is not toxic even at the highest dose. We therefore anticipate having to use 50X-100X the efficacious dose if we cannot produce toxicity, making the cost of the peptide very high if we were to test it in dogs. Since the funding of the grant, because of the pandemic and recent trade-wars with China, where monkeys are sourced, there is a dire shortage of non-human primates. As a result, the price per monkey has more than doubled. This Administrative Supplement application is to help offset the increased cost of the monkey studies that are within the scope of the approved award but were unforeseen when the application was submitted and reviewed.

概括母公司商业化准备计划拨款用于进行研究有必要支持与 Cenna 临床前开发相关的监管提交候选肽药物mP8。 mP8 正在被开发为一种新的、一流的肽药物，用于治疗阿尔茨海默病的治疗。资助的赠款建立在所取得的实质性进展的基础上根据先前资助的 SBIR 第 2 阶段和 2B 赠款，开展支持未来的活动首次进行 mP8 人体临床研究。所要求的研究的必要组成部分 FDA 将开展 IND 药物安全毒性和 GLP 安全药理学研究两种动物。对于肽、小分子和其他药物模式，研究使用 FDA 需要啮齿动物和非啮齿动物物种来支持临床开发和许可。当提交家长补助金时，我们曾提议使用食蟹猴作为这些研究的非啮齿动物模型，因为它是临床前公认的物种毒性测试，并且在系统发育和生理学上与人类更密切相关比狗。猴子也比狗小得多，因此需要的肽要少得多。这很重要，因为我们迄今为止的研究表明我们的原始肽 P8 无毒即使在最高剂量下。因此，如果出现以下情况，我们预计必须使用 50X-100X 的有效剂量：我们不能产生毒性，如果我们要在狗身上进行测试，那么肽的成本会非常高。自赠款提供以来，由于大流行和最近与中国的贸易战，在猴子的来源地，非人类灵长类动物严重短缺。结果，每只猴子的价格增加了一倍多。此行政补充申请旨在帮助抵消批准奖励范围内的猴子研究增加的费用但在提交申请和审核时却出乎意料。