Human trials may eventually be allowed, but I suspect that the results are preliminary and much work still needs to be done to assess the drug's safety before it makes it to humans.
Let me tell you a story about a biotech startup that I worked at many moons ago.
- We were trying to develop new antibiotics to treat certain bacterial infections.
- We had created a new antibiotic that was chemically similar to an existing, commercially successful antibiotic.
- But our drug was ~2-4× more potent at killing certain pathogenic bacteria than the existing med.
- Sounds good for us, right?
- Well, the commercially successful antibiotic was also toxic to humans if administered for "long" periods (it causes severe anemia if administered for 20+ days [I may not remember the precise details here]).
- Therefore, we were concerned that if our drug was 2-4× more potent at killing the microbes, it might also be 2-4× more toxic to people.
- To obtain approval for human tests, we had to run toxicity tests of our drug using several non-human species. Those results were mixed (toxic in some species, non-toxic in others), but we did eventually get approval.
- Unfortunately, the original concerns were correct: our drug caused severe anemia within ~3 days (again, specifics may be wrong), which means that particular candidate died in Phase 1 (initial human trial assessing drug safety).
Thankfully, the severe anemia was reversible in our test subjects (stop taking the drug, and the anemia went away)
Let me tell you a story about a biotech startup that I worked at many moons ago.
- We were trying to develop new antibiotics to treat certain bacterial infections.
- We had created a new antibiotic that was chemically similar to an existing, commercially successful antibiotic.
- But our drug was ~2-4× more potent at killing certain pathogenic bacteria than the existing med.
- Sounds good for us, right?
- Well, the commercially successful antibiotic was also toxic to humans if administered for "long" periods (it causes severe anemia if administered for 20+ days [I may not remember the precise details here]).
- Therefore, we were concerned that if our drug was 2-4× more potent at killing the microbes, it might also be 2-4× more toxic to people.
- To obtain approval for human tests, we had to run toxicity tests of our drug using several non-human species. Those results were mixed (toxic in some species, non-toxic in others), but we did eventually get approval.
- Unfortunately, the original concerns were correct: our drug caused severe anemia within ~3 days (again, specifics may be wrong), which means that particular candidate died in Phase 1 (initial human trial assessing drug safety).
Thankfully, the severe anemia was reversible in our test subjects (stop taking the drug, and the anemia went away)