[metiscus]

As many others have said, this appears to be a puff piece almost entirely devoid of meaningful content. There is currently one ongoing phase 1 trial for the drug in question, AOH1996. That phase 1 trial is scheduled to end in March or April of 2024 so we may have some answers about the safety of the treatment.

It is important to remember, when discussing these things, how clinical trial phases work. There are four main trial phases in a drug development cycle.

A Phase 1 trial is used to determine if a treatment is safe and to determine the maximum dosing. A preliminary result about the effects of the drug is a side product of a Phase 1 trial but this is not sufficient to know if a drug will succeed. Phase 1 trials are primarily about safety.

A Phase 2 trial is used to determine the efficacy of a treatment and to determine the best and most effective way to use that treatment. A drug that has a successful Phase 2 trial is likely to be effective but merely being effective is often insufficient for a drug to be considered a success.

A Phase 3 trial compares the effectiveness of a treatment against the current standard treatments. A new treatment must be better than the existing treatments in some way (e.g. same effect on the disease but lower side-effects, more effective in general, etc) to have a successful Phase 3 trial. A Phase 3 trial is the last regulatory hurdle to the approval of a treatment for use.

A Phase 4 trial, is performed after a treatment is developed and brought to market. The most common type is post-marketing surveillance where data is gathered about the effectiveness of the treatment, side effects, etc from observational studies of the treatment as used. These data are compared with the data developed during the Phase 3 randomized controlled trial to ensure that the treatment is performing like it should in the market. Differences between Phase 3 results and Phase 4 results can result in modifications to the box (e.g. a black box label), prescribing information, or other aspects of the treatment's packaging and marketing.

Hopefully this was helpful.

[cowsandmilk]

While phases are a useful classification, looking at the outcome measures for a clinical trial is more useful for understanding the objective of the study and what will be answered.

On https://clinicaltrials.gov/study/NCT05227326 , opening up “What is the study measuring?” shows this one has primary outcomes of safety, but also has secondary outcomes around effectiveness of treatment.

[Turing_Machine]

> A Phase 1 trial is used to determine if a treatment is safe and to determine the maximum dosing.

There are also nuances here. A drug that's effective against some type of cancer can be deemed safe (or at least safe enough) even if it has truly horrific and/or dangerous side effects, because it's cancer, while a drug with the same safety profile would never be approved for, say, athlete's foot.

[metiscus]

Everything in medicine is about weighing comparative risks - nothing is completely safe if you look at it hard enough. Well raised point, thanks.