Biotechnology

Is Cassava Sciences Underestimating Their Phase 3 Clinical Trials? (October 2024)

Cassava Sciences is a clinical-stage biotechnology company developing several late-stage treatments for Alzheimer's.

A friend recently heard about Cassava in the news and asked me if I had any insights based on the recent biotech data I've been exploring.

I thought it was a good opportunity to spin up Biotech Hunter and see what it can do.

The results are mildly interesting:

It looks like Cassava likely has confidence or is putting in extra measures to ensure statistical significance with their larger enrollment size for their recent Phase 3 trials.
However, it also looks like Cassava's larger enrollment diverges from other benchmarks. Duration, sites, and enrollment rate all seem to track benchmarks in comparison. I would usually say that Cassava is underestimating the time and cost for its target enrollment, but it looks like their studies are currently "active, not enrolling."

This needs further analysis since clinicaltrials.gov is notorious for messy data and the tool is still early.

I'm curious:

What else have people been looking for in publically available clinical data?
What are your biggest pain points in understanding the current clinical trial landscape?

Drop me a note.

The more detailed analysis I sent to my friend is below.

Cassava Sciences Phase 3 Alzheimer's Benchmarks

Background

This is a quick analysis on Cassava’s current trials based on the clinical trial benchmarking tool that I've been playing around with.

The data tool is still rough so it might have some errors, and it doesn’t tell anything about the science, but it does lead me to believe that Cassava has confidence in their current Phase 3 trials (the trials they need to get FDA approval), but they’re underestimating the time/cost it will take to complete them.

Takeaways

Cassava likely has high confidence in their Phase 3s or is mitigating risk by putting in extra measures to ensure statistical significance by using a much larger sample size than most other comparable Alzheimer’s.
Cassava's larger enrollment diverges from other benchmarks. Duration, sites, and enrollment rate all seem to track benchmarks in comparison. I would usually say that Cassava is underestimating the time and cost for its target enrollment, but it looks like their studies are currently "active, not enrolling."

This needs further analysis since clinicaltrials.gov is notorious for messy data and the tool is still a prototype.

Comparisons

Comparison of Cassava Ongoing Phase 3 Trials to Completed and Ongoing Alzheimer’s Phase 3 Trials:

	Overall	Comparison to: Complete Alzheimer's Phase 3s	Comparison to: Ongoing Alzheimer's Phase 3s
Study Duration	About benchmark	Cassava near median	Cassava near median
Enrollment	Meaningfully larger than benchmark	Outside of standard deviation significantly	Around standard deviation
Number of sites	About benchmark	A bit higher than median	A bit higher than median, but trend is to have more sites
Enrollment rate (patients / month / site)	About benchmark	Completed studies seem to have much higher rates (might be an artifact of getting sites up to speed)	Near or slightly below the median for ongoing enrollments