Update On Teplizumab

[joshua levy]

Here are three recent updates on Teplizumab.  You can read my previous summary of this drug here:https://cureresearch4type1diabetes.blogspot.com/2019/09/teplizumab-phase-ii-results-for.htmland all my Teplizumab postings here:https://cureresearch4type1diabetes.blogspot.com/search/label/Teplizumab

Updates from ADA 2020

The Teplizumab update from ADA 2020 contained several important pieces:

The average delay in onset of T1D rose from about 2 years in the previous reports, to 3 years.  This is based on following the same group of people but for a longer period of time.  My interpretation of this is that some people are simply not helped by this treatment, and they are later diagnosed with T1D.  However, for the people the treatment does help, it prevents T1D for a relatively long time, and as we follow these people for longer, that time gets longer too.  This is a good thing.

People treated with Teplizumab generated more C-peptide, in response to food, in the six months after treatment, then they had before.  This is important because usually, during this phase of the disease, C-peptide generation is slowly decreasing.  (And that was seen in the untreated group.)  C-peptide is generated by beta cells as part of their generation of insulin.  So generating more C-peptide means the beta cells are recovering or regenerating in some way.  Previous studies (in Teplizumab and other drugs) have sometimes shown preservation of insulin production by beta cells.  They stop decreasing.  But to the best of my knowledge, this is one of the few times a drug has shown increases in insulin production by beta cells in a human trial.

People in this study seemed to go through three phases: during the 6 months after treatment, their C-peptide numbers increased.  Then those numbered stayed mostly stable for months or years.  Some people continued to stay stable and were not diagnosed with T1D, while others started dropping and about 6 months after their C-peptide levels started dropping they were diagnosed with T1D.

Obviously, there are a couple of key questions that we don't know the answers to:

1. Will repeated dosing of Teplizumab continue to delay the onset of T1D?
   
2. Will dosing of Teplizumab in people with established T1D lead to increased insulin production, and therefore make their T1D easier to treat?  This study shows that increase for people who are at-risk of T1D, but we don't know about people who already have T1D.
3. Is there are some way to know ahead of time what sort of at-risk people will be helped by this treatment, and which will not?
   

Great write up from JDRF / Beyond Type-1: https://beyondtype1.org/teplizumab-updates-ada-2020/

Video from the researcher: https://www.facebook.com/watch/?t=42&v=264451347972017

Abstracts of the two ADA 2020 presentations:

    https://diabetes.diabetesjournals.org/content/69/Supplement_1/276-OR

    https://diabetes.diabetesjournals.org/content/69/Supplement_1/277-OR

Starting A Phase-II Trial In Honeymooners

The same group that ran the successful study to see if Teplizumab could delay the onset of T1D are now running a follow-up trial.  People previously treated with Teplizumab, but who later came down with T1D, are treated again with Teplizumab to see if it has any effect on the course of their T1D.   Remember, the previous effect was to delay the onset of T1D, so now we will learn if doses after diagnosis make for a slower onset or preserve some beta cells.

This is a 30 person study.  Everyone will get the treatment and will be followed for 18 months.  No control group.  The study's primary end points are safety related, but the secondary end points include C-peptide production (showing if the body is generating its own insulin) and several other measurements.  They started in March 2020 and hope to finish in August 2024.

This study is only open to people who took part in the earlier Teplizumab study titled Teplizumab for Prevention of Type 1 Diabetes In Relatives "At-Risk"  which is TrialNet study TN-10. The contact information for this study is Provention Bio Chief Medical Officer, 908-356-0514, era...@proventionbio.com

Registration: https://www.clinicaltrials.gov/ct2/show/NCT04270942

Ongoing PREVENT Trial

There is also the ongoing PREVENT trial of Teplizumab.  This is a phase-III study being done on honeymooners.  Due to COVID-19, they have paused recruiting new patients into this study, but when the emergency is over, they will restart recruiting.  This study needs 300 people.  You can read the study's web page here: 

https://theprotectstudy.com/home/

and the trial registry here:

https://clinicaltrials.gov/ct2/show/NCT03875729

Joshua Levy

http://cureresearch4type1diabetes.blogspot.com

publicjoshualevy at gmail dot com

All the views expressed here are those of Joshua Levy, and nothing here is official JDRF or JDCA news, views, policies or opinions. My daughter has type-1 diabetes and participates in clinical trials, which might be discussed here. My blog contains a more complete non-conflict of interest statement. Thanks to everyone who helps with the blog.