Aadi Bioscience Inc (NASDAQ: AADI) announced that it has begun dosing for its Phase II trial for patients aged 12 and above who have solid tumors and inactivating TSC2 and TSC1 gene alterations. The company tested to see if nab-sirolimus could effectively treat these disorders.
The U.S food and Drug Administration (FDA) gave the company fast track designation for nab-sirolimus. This designation accelerates developing and reviewing therapies for severe ailments with high unmet clinical needs.
The drug could be benefit thousands of Americans
According to the President, CEO, and founder of Aadi, Neil Desai, the company is examining the compound’s efficacy in inactivating TSC2 and TSC1 alterations after the GDA approved its launch for malignant PEComa. These alterations often occur in more than 10,000 patients with cancer each year; thus, the drug could represent an opportunity to treat thousands of patients.
Desai adds that the company’s commencement of the registration trial shows that it can meet its milestones in drug development. Moreover, it shows the company’s dedication to exposing the use of nab-sirolimus. Aadi is on its way to becoming an oncology company that treats multiple indications.
The study is a tumor agnostic open-label, multicenter registrational study. It will investigate about 60 volunteers who are mTOR naive in two separate study arms. The company expects to have preliminary data from the study by the first part of 2023.
The CMO of Aadi, Dr. Loretta Itri, states that the company is happy to have begun dosing for its clinical trial. She adds that this study comes when there are no therapy options for TSC2 and TSC1 alterations.
Past studies make the company hopeful about the drug’s efficacy
Dr. Itri explains that the trial investigates the tolerability, safety, and efficacy of nab-sirolimus in tumor patients with TSC1 and TSC2 alterations. The company believes from past experiments that the drug could effectively treat patients with these issues. Dr. Itri explains that the researchers will split the trial into two to evaluate the drug’s effect on TSC2 and TSC1 independently.
Aadi Bioscience is a pharmaceutical company that develops precision treatments for cancers that affect the genes.