First to Proof-of-Concept Case Study I
“As Quickly as Possible …”
Issues
The client wanted to know as quickly as possible if a new compound was going to work, so they could accelerate their go/no-go decision. But neither the client nor Cetero wanted to rush so fast that safety was compromised.
The client wanted to know as quickly as possible if a new compound was going to work, so they could accelerate their go/no-go decision. But neither the client nor Cetero wanted to rush so fast that safety was compromised.
With our First to Proof-of-Concept service, we work to optimize each protocol for both speed and safety. This enables us to streamline first-in-human to proof-of-concept studies by up to 50%.
Challenges
The protocol required a delicate balance between flexibility (to adjust dosages for later cohorts based on safety data from earlier ones) and precision (to satisfy regulatory requirements). We worked to fine-tune the protocol as safety data began to come in, to give us an early edge in setting dosage and stopping parameters.
The protocol required a delicate balance between flexibility (to adjust dosages for later cohorts based on safety data from earlier ones) and precision (to satisfy regulatory requirements). We worked to fine-tune the protocol as safety data began to come in, to give us an early edge in setting dosage and stopping parameters.
Cetero Approach
We conducted the first, single ascending dose (SAD) phase of the study in seven different cohorts of participants. The safety data from Cohort Three, which received 10 mg doses, showed no problems; so we immediately began testing Cohort One of the next phase (multiple ascending dose, or MAD) while we completed the remaining cohorts of the SAD test. To ensure a wide margin of safety, we began the MAD study at a dosage of three mg. The remaining cohorts of the MAD study also overlapped the increasingly higher-dosage cohorts of the SAD study.
We conducted the first, single ascending dose (SAD) phase of the study in seven different cohorts of participants. The safety data from Cohort Three, which received 10 mg doses, showed no problems; so we immediately began testing Cohort One of the next phase (multiple ascending dose, or MAD) while we completed the remaining cohorts of the SAD test. To ensure a wide margin of safety, we began the MAD study at a dosage of three mg. The remaining cohorts of the MAD study also overlapped the increasingly higher-dosage cohorts of the SAD study.
We also needed to conduct a food effect study because the final proof-of-concept phase was to be conducted with patients taking multiple doses at home, sometimes under fed and sometimes under fasting conditions. We further condensed the timeline by overlapping this phase with the MAD phase.
Results
In this particular study, we were able to measure true symptoms and the effect the compound had on them. The results were good, and our client had the data to make the go/no-go decision in an unusually short period of time.
In this particular study, we were able to measure true symptoms and the effect the compound had on them. The results were good, and our client had the data to make the go/no-go decision in an unusually short period of time.
Describing the process is easy. But putting it all together took the careful coordination of an experienced clinical team – experience that sets Cetero apart. In short, our clients benefit from what we do, not from what we say.
Please contact us about your next proof-of-concept challenge, and discover what we can do to make you First to Proof-of-Concept.
