Updated Review
Published: August 23, 2021
We found no new studies confirming a mechanism of action for Aimspro in ALS. Therefore our TOE Mechanisms Grade remains C. We saw a presentation by Professor Syed Haq at the 2013 American Academy of Neurology Meeting. This included data from a small flawed study in the mSOD1 mouse model of ALS in which Aimspro delayed disease onset but did not affect survival. This does not appear to have been published except in abstract form. Thus, our TOE Pre-Clinical Grade is D. We found no new case reports so our TOE Cases Grade remains D. In Dr. Haq's 2-13 presentation he also described a 21 patient open label trial of Aimspro. Some clinical outcomes were stable and others showed slight improvements bu the lack of a control group in this trial prevents any definite conclusion. Thus, our TOE Trials Grade remains D. There were no adverse events reported in that small unpublished trial. We found a published trial of Aimspro in patients with systemic sclerosis. In the 10 patients treated with Aimspro, there were 3 patients who experienced SAEs. These included a cerebral infarct, pulmonary embolus, atrial fibrillation and respiratory tract infection. Given this high frequency of SAEs in the only published trial of Aimspro we found, we change our TOE Risks Grade to F. Our conclusion remains unchanged: we do not recommend Aimspro as a treatment for ALS.
Key Information
Click on any letter grade below for more info:
Mechanism Grade: C
Preclinical Trials Grade: D
Cases Grade: D
Trials Grade: D
Risks Grade: F
Published: Nov 2010
The mechanism of Aimspro remains unproven; if it is an immunomodulator and/or a modulator of sodium channels, it theoretically could be useful in ALS. A single, detailed but significantly flawed case report documents slowing in decline of certain respiratory functions in a patient claiming to have ALS, who started Aimspro shortly after bipap. Based upon this limited information, ALSUntangled supports further study of Aimspro, either in ALS animal models or in a small phase 2 trial with clear and objective endpoints carried out by skilled trialists familiar with the problems inherent with ALS clinical studies. Until a trial is undertaken, however, we do not support further use of this product by PALS.