An $8 million clinical trial of ASP0367 for patients with poor systemic oxygen extraction

A Study to Evaluate ASP0367 in Participants With Reduced Maximum Oxygen Uptake Due to Poor Systemic Oxygen Extraction

The purpose of this study is to to evaluate the effect of ASP0367 on improvement of aerobic capacity relative to placebo, as well as evaluate the safety and tolerability of ASP0367 relative to placebo. This study will also evaluate the effect of ASP0367 on improvement of other aerobic capacity parameters relative to placebo, as well as evaluate the effect of ASP0367 on improvement of functional capacity relative to placebo.


Study entry on clinicaltrials.gov

Healthrising article on this study

ASP0367 targets the PPAR pathway and is described as mitochondrial drug.

 

I take carnitine which seems similar to this drug as it also acts on PPAR and improves utilization of fats for energy production. Carnitine lets me do more and for longer.

 

Merged thread

https://www.healthrising.org/blog/2022/04/23/mitochondrial-chronic-fatigue-syndrome/
$8 Million Clinical Trial of a Mitochondrial Booster Underway in ME/CFS
by Cort Johnson | Apr 23, 2022 | Autonomic Nervous System, Cardiovascular, Energy Production, Homepage, Mestinon, Metabolism, Research |

 

But the clinical trial web site does not explicitly mention MECFS?

Is this the largest trial (funding-wise) of a clinical drug trial for MECFS? (IIRC RITUX had more patients).

 

"Reduced Maximum Oxygen Uptake" compared to what? They are comparing it to age based norms, but an individual could have higher than average oxygen uptake (peak oxygen uptake during CPET) yet it could still be restricted by the same mechanisms as people with below average oxygen uptake.

 

There is no substitute for a control group, though it also depends on the stage of the study. Early investigations might be easier without a control, and result in data that justifies the cost of a large controlled trial. Drug companies lose lots of money on unsuccessful trials, and want preliminary data. Grant agencies have the same concerns.