Responding to Scrip’s question on the overall likelihood of approval (LOA) for new assets entering Phase I declining to 6.7% in 2023 from 7.9% three years before, as shown by a 10-year dataset from Biomedtracker, Gohil said a likely reason could be that sponsors are trying to fail early.

Pyke agreed, saying “Certainly, in my time in the industry, there's been an increasing focus on fail fast, fail cheaply. And Phase I or II is the time to do that, you can't fail cheaply in Phase III when you're in deep. So, that actually might be a signal that things are working rather well.”

The report also shows despite stricter criteria for go/no-go decisions at Phase I, Phase II and Phase III success rates have also declined, though not to the same extent. To Scrip’s point that Phase II remains the greatest hurdle, with just a 28% probability of success, he responded: “Historically, the pattern has tended to be that the success rates in Phase II are the lowest meaning we're weeding out” candidates less likely to be effective.

“Often, there’s not that middle ground and to be clear most drugs don't work at all. That's what we discover - they're safe because they're not doing anything much, sadly. And that's why you see high failure rates in Phase II and clinical development programs are typically designed with that in mind,” he added.

While “that's shifted a bit, particularly with precision medicine, particularly with the insights that we've developed around oncology treatments, nonetheless failing in Phase II is not necessarily a bad thing and in fact it may even be a good thing,” he concluded.

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