The Product

ABI-009 is a clinical phase, ‘best-in-class’, targeted mTOR inhibitor with demonstrated safety and evidence of efficacy. A Registration enabling trial (endpoints pre-negotiated with the FDA) is ongoing in Advanced Malignant PEComa (a rare aggressive form of sarcoma). ABI-009 has Orphan Designation, Fast Track Designation and the registration trial completion and NDA filing is targeted for 2019.

ABI-009 has a unique and advantageous clinical and pharmacological profile including efficient CNS penetration. Unlike other drugs in its class, ABI-009 is being developed in highly select populations in diseases driven by mTOR activations in oncology, cardiovascular and CNS diseases with an eye towards de-risked and capital efficient path to registration.

The Product

March, 7 2019, Aadi Bioscience, Inc. (Aadi), For the first time in his life, Shanahan “Shanny” Dameral, 19, has a girlfriend. Soon, he’ll be graduating with a high school diploma and looking for his first job on the Kitsap Peninsula. What seems routine for many is a big deal for Dameral and other children living with treatment-resistant or intractable epilepsy. For reasons largely unknown, seizures in this subset of children persist long past their discovery in early childhood despite being treated with multiple medications and undergoing surgery to remove the affected parts of their brain. Diagnosed with epilepsy at age 5, life for Dameral has always come with seizures attached. When his seizures returned after a second brain surgery shortly after his 16th birthday, his mom Linley Allen, hoped for a medical breakthrough. “We needed to find something else since another surgery was out of the question,” Allen said. “We had heard about a drug being studied for a more severe seizure condition. I kept holding onto hope that it might be expanded to treat Shanny’s type of seizures because it was all we had at the time.”   See all and the original News article here: New Drug Trial Gives Hope for Treatment-Resistant Epilepsy