First to Proof-of-Concept Case Study II
Shortening a Timeline, Despite a Significant Obstacle
Issues
It was a new compound. In fact, it was so new that there was nothing similar on the market. That meant we had no previous data on which to base the study design.
It was a new compound. In fact, it was so new that there was nothing similar on the market. That meant we had no previous data on which to base the study design.
At the same time, the client wanted to reach a go/no-go decision as rapidly as possible.
The compound was an obesity treatment. The go/no-go decision involved collecting safety data and preliminary insights into efficacy.
Challenges
Our First to Proof-of-Concept service combines multiple studies in a single overlapping protocol, so sponsors can move more quickly from first-in-human dosing to proof-of-concept. Normally, this requires up to four separate studies (SAD, MAD, bridging PK and POC). Our single protocol approach cuts the time from first in human to proof-of-concept by up to 50%.
Our First to Proof-of-Concept service combines multiple studies in a single overlapping protocol, so sponsors can move more quickly from first-in-human dosing to proof-of-concept. Normally, this requires up to four separate studies (SAD, MAD, bridging PK and POC). Our single protocol approach cuts the time from first in human to proof-of-concept by up to 50%.
But in this case, because the type of compound was completely untested, we had to be extremely cautious with the SAD study to ensure participant safety. Participants in the SAD study were dosed one at a time, and overlapping MAD with SAD was not an option.
Cetero Approach
We evaluated food effect (fasting vs. fed) in the last two cohorts of the SAD study rather than between MAD and proof-of-concept, because we needed the food effect data before we could safely condense the latter part of the study. First we established safety. Then we actually built the proof-of-concept study into the MAD study, thus evaluating how the compound worked in patients at the same time we were evaluating how safe it was in multiple doses.
We evaluated food effect (fasting vs. fed) in the last two cohorts of the SAD study rather than between MAD and proof-of-concept, because we needed the food effect data before we could safely condense the latter part of the study. First we established safety. Then we actually built the proof-of-concept study into the MAD study, thus evaluating how the compound worked in patients at the same time we were evaluating how safe it was in multiple doses.
Results
Despite proceeding with caution due to safety concerns, we were able to accelerate the client’s go/no-go decision and move the compound to Phase II. As with all Cetero early phase studies, we put participant safety first but were still able to exceed the client’s expectations with the speed of the results.
Despite proceeding with caution due to safety concerns, we were able to accelerate the client’s go/no-go decision and move the compound to Phase II. As with all Cetero early phase studies, we put participant safety first but were still able to exceed the client’s expectations with the speed of the results.
If you have a challenge that doesn’t quite fit the mold, contact us today. And we’ll show you an effective way to deal with it.
