MODULATORS OF mTORC1 ACTIVITY AND USES THEREOF
The present invention relates to compounds and methods useful for selectively modulating mTORC1 activity.
1 . A compound having the formula LiCl*compound I, or a solvate or hydrate thereof, wherein compound I has the structure:
2 . The compound of claim 1 , wherein the LiCl*compound I is a co-crystal.
3 . The compound of claim 1 , wherein the lithium and the compound I are in a stoichiometric ratio of about 1 to about 1.
4 . A pharmaceutical composition comprising the compound according to claim 1 and a pharmaceutically acceptable carrier, adjuvant, or vehicle.
5 . The pharmaceutical composition according to claim 4 , wherein the composition is formulated for oral administration.
6 . The pharmaceutical composition according to claim 4 , further comprising an additional therapeutic agent.
7 . A method of treating, preventing, and/or reducing a risk of a disease, disorder, or condition mediated by mTORC1 in a patient comprising administering to a patient in need thereof an effective amount of the compound according to claim 1 or the pharmaceutical composition according to claim 4 .
8 . The method of claim 7 , wherein the disease, disorder, or condition mediated by mTORC1 is depression, bipolar disorder, schizophrenia, chronic unpredictable stress, autism, lysosomal storage disease, Batten disease, cystinosis, Fabry disease, mucolipidosis, mental retardation, anorexia, bulimia, anemia, neutropenia, headache, alcoholism, post-traumatic stress disorder (PTSD), epilepsy, diabetes, liver disease, kidney disorders, arthritis, skin conditions such as seborrhea, overactive thyroid, asthma, Huntington's disease, Graves' disease, herpes simplex, movement disorders such as tardive dyskinesia, Tourette's syndrome, cyclical vomiting, Meniere's disease, tingling or crawling sensation in the skin (paresthesias), or aggressive behavior in attention deficit-hyperactivity disorder (ADHD).
9 . A method of treating treatment-resistant depression in a patient in need thereof, said method comprising administering to said patient an effective amount of the compound according to claim 1 or the pharmaceutical composition according to claim 4 .
10 . A method of treating major depressive disorder in a patient in need thereof, said method comprising administering to said patient an effective amount of the compound according to claim 1 or the pharmaceutical composition according to claim 4 .