1) Metabolic side effects tend to be slow and subtle. Vioxx caused increased heart attacks over time. Passing a phase 1 safety trial is fine and dandy, but it’s a far cry short of long-term safety in a drug targeting metabolism, and it’s not even where most drugs fail.
2) Lab evidence for a biomarker for a metabolic process is so far short of evidence of clinical improvement that it’s a joke. I will never stop deriding studies that point to proxy markers (or in this case, proxy proxy markers) as evidence of benefit. This has been proven to be inadequate so many times, across so many different studies, that it’s just not worth talking about anymore.
This is a perfectly fine and valid phase 1 study. It says “we have identified a dose range that doesn’t immediately sicken people.” That’s what phase 1 trials do. The rest is press release hype.
2) Lab evidence for a biomarker for a metabolic process is so far short of evidence of clinical improvement that it’s a joke. I will never stop deriding studies that point to proxy markers (or in this case, proxy proxy markers) as evidence of benefit. This has been proven to be inadequate so many times, across so many different studies, that it’s just not worth talking about anymore.
This is a perfectly fine and valid phase 1 study. It says “we have identified a dose range that doesn’t immediately sicken people.” That’s what phase 1 trials do. The rest is press release hype.