Use of masitinib for treatment of an amyotrophic lateral sclerosis patient subpopulation

1. A method for treating amyotrophic lateral sclerosis (ALS) in a patient having a score progression, before treatment initiation, of less than 1.1 points per month according to the revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R), said method comprising administering to the patient an inhibitor of at least one tyrosine kinase selected from the group consisting of c-Kit, Lyn, Fyn, PDGFR, and CSF1R, and any combination thereof.

2. The method according to claim 1 , wherein said patient has a score progression, before treatment initiation, of less than 0.8 points per month according to the ALSFRS-R.

3. The method according to claim 1 , wherein said patient has a score progression, before treatment initiation, of less than 1.1 points per month and equal to or greater than 0.8 points per month (≥0.8 to <1.1 points per month) according to the ALSFRS-R.

4. The method according to claim 1 , wherein said inhibitor is an inhibitor of mast cell activity.

5. The method according to claim 4 , wherein said mast cell inhibitor is chosen from the group consisting of: masitinib, imatinib, cromolyn sodium, midostaurin, BLU-285, bosutinib, ibrutinib, LAS189386, DP-2618, fostamatinib, nilotinib, dasatinib, sunitinib, axitinib, pazopanib, and toceranib.

6. The method according to claim 1 , wherein said inhibitor is an inhibitor of microglia cell activity.

7. The method according to claim 6 , wherein said microglia cell inhibitor is chosen from the group consisting of: masitinib, GW2580, pexidartinib, BLZ945, linifanib, OSI-930, imatinib, sunitinib, nilotinib, pazopanib, emactuzumab, FPA008, quizartinib, axitinib, motesanib, cediranib, JNJ-28312141, Ki-20227, MLN-518, sorafenib, and SU-14813.

8. The method according to claim 1 , wherein said inhibitor is a 2-aminoarylthiazole derivative.

9. The method according to claim 8 , wherein said inhibitor is masitinib or a pharmaceutically acceptable salt or solvate thereof.

10. The method according to claim 9 , wherein the pharmaceutically acceptable salt of masitinib is masitinib mesilate.

11. The method according to claim 1 , wherein said inhibitor is administered at a dose ranging from about 1.0 to about 9.0 mg/kg/day (mg per kilo body weight per day).

12. The method according to claim 1 , wherein said inhibitor is administered at an initial dose of 3.0 mg/kg/day during at least 4 weeks, then 4.5 mg/kg/day during at least 4 weeks, and at 6.0 mg/kg/day thereafter, with each dose escalation being subjected to toxicity controls.

13. The method according to claim 1 , wherein said inhibitor is administered at a dose of 4.5 mg/kg/day.

14. The method according to claim 1 , wherein said inhibitor is administered at a dose of 6 mg/kg/day.

15. The method according to claim 1 , wherein said inhibitor is administered in two daily intakes.

16. The method according to claim 1 , wherein said inhibitor is administered orally.

17. The method according to claim 1 , wherein said inhibitor is administered in combination with at least one other pharmaceutically active ingredient.

18. The method according to claim 17 , wherein said at least one other pharmaceutically active ingredient is an antiglutamate compound, or an inhibitor of glutamate carboxypeptidase II.

19. The method according to claim 18 , wherein said antiglutamate compound is selected from the group consisting of riluzole, topiramate, gabapentin, lamotrigine, talampanel, and ceftriaxone.

20. The method according to claim 18 , wherein said antiglutamate compound is riluzole.