Larazotide, drug to treat celiac disease, discontinued in Phase 3

[Adam 50]

  In the past few years, I have followed the news about Larazotide phases, the only drug for celiac disease that was on phase 3. I noticed today that it has been discontinued in phase 3. Basically what it said in this article doesn't make any sense. Nevertheless, the news was disappoining. We may be able to have easier life in the near future, but we will still need to wait at least another few years.  

  Find out more about the other phases of celiac disease drugs in this link. Most are in phase 1 and few are in phase 2.  

[RMJ]

Quote

An interim analysis of patient data in the CedLara trial found that the size of the treatment group that would be needed to determine a significant clinical outcome between study participants receiving the drug and those getting a placebo was too large to support continuation of the trial, the company said in a press release.

Translation:  The observed benefit (improvement of symptoms) was very small.

FDA requires statistically significant results.  In order to see a statistically significant result for a small change, a lot of subjects are required.  

It looks like they will be analyzing the data to see if there is a subgroup of patients that the drug helps more.  For example, maybe women over 60, or people who have had celiac disease for X years (these are made up examples). If so, then they can do a clinical trial in a reasonable number of people in that subgroup.

[Adam 50]

34 minutes ago, RMJ said:

Translation:  The observed benefit (improvement of symptoms) was very small.

FDA requires statistically significant results.  In order to see a statistically significant result for a small change, a lot of subjects are required.  

It looks like they will be analyzing the data to see if there is a subgroup of patients that the drug helps more.  For example, maybe women over 60, or people who have had celiac disease for X years (these are made up examples). If so, then they can do a clinical trial in a reasonable number of people in that subgroup.

In 2018 or 2019, when I was following the news about this drug, the update said that Phase 3 would end by 2020, and that the drug would be available to the public by then. During the pandemic, we did not have an update until it was completely canceled. Can you tell me how long Phase 3 usually lasts? If it continues until the end, of course.

[RMJ]

I don’t think there is a “usual” for Phase 3 length.  There are a lot of factors that can affect how fast subjects can be enrolled:  number of clinical sites, prevalence of disease in the population, how hard the investigators (doctors) work to enroll patients, how strict the inclusion/exclusion criteria are, etc.  My guess is that enrollment really slowed down during the pandemic.