ME-344 is under clinical development by MEI Pharma and currently in Phase I for Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer (HER2- Breast Cancer). According to GlobalData, Phase I drugs for Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer (HER2- Breast Cancer) have a 90% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how ME-344’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

ME-344 overview

ME-344 is under development for the treatment of metastatic colorectal cancer, HER2 negative breast cancer and relapsed acute myeloid leukemia, refractory acute myeloid leukemia. The drug candidate is administered as intravenous infusion. It acts by targeting NADH Dehydrogenase and cytochrome bc1 complex. It is an isoflavone-derived mitochondrial inhibitor, an active metabolite of NV-128 that inhibits mTORC-1 and mTORC-2. The drug candidate is developed based on captisol (a patent protected, chemically modified cyclodextrin), a formulation technology.

It was also under development for the treatment of platinum-refractory ovarian, metastatic small cell lung cancer and cervical cancer.

MEI Pharma overview

MEI Pharma (MEI Pharma), formerly Marshall Edwards, develops drugs for the treatment of cancer. The company’s drug candidates include pracinostat, an oral histone deacetylase inhibitor, intended for the treatment of advanced hematological diseases including myelodysplastic syndrome; ME-344, a mitochondrial inhibitor intended for the treatment of HER2-negative breast cancer and solid tumors; and Zandelisib (ME-401), an oral PI3K delta inhibitor for relapsed or refractory B-cell malignancies. It also develops and commercializes Voruciclib, an oral and selective cyclin-dependent kinase (CDK) inhibitor intended for the treatment of acute myeloid leukemia (AML) and B-cell malignancies through an agreement with Presage. MEI Pharma is headquartered in San Diego, California, the US.

For a complete picture of ME-344’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 10 June 2024

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GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.