At the start of a new year, some bloggers write a posting on the year that was, and a some write a posting on what they expect in the new year. This posting is a little of each.
The Big News From Last Year
Teplizumab! Which became the product Tzield. Getting a drug approved that actually changed the course of T1D is a big deal. I know it is for people at-risk, not people who have T1D. I know it only delays the onset of T1D. I know it is incredibly expensive. Those things matter, especially in the short term, but in the long term this is still a huge breakthrough.
And next year, it may well expand. I recently reported on a phase-III clinical trial done on honeymooners:
https://cureresearch4type1diabetes.blogspot.com/2023/11/teplizumabtzield-reports-results-from.html
It is also being tested on younger kids, to expand the people who can benefit from it. I'm also hoping that more widespread use will lead to more knowledge about how it works, and maybe even a realization that it delays T1D even longer than we know now.
Also, we have seen a few more clinical trials running in 2023 than in previous years. I'm not sure if that is just a post-COVID bounce, or real and continuing growth in the human trial pipeline. We are a little higher than our pre-COVID numbers (more clinical trials), so I'm hoping this is actual growth. It is possible that previous research and Teplizumab's approval has laid a foundation that will accelerate future research. I'm an optimist.
What I'm Watching In The New Year
Semaglutide (sold as: Ozempic, Wegovy and Rybelsus) had very strong results in a very small study of honeymoon T1Ds:
https://cureresearch4type1diabetes.blogspot.com/2023/09/strong-results-from-pilot-study-of.html
People who took the drug sometimes did not need to inject insulin for a year. Other people had to inject long acting insulin, but did not need to inject at meal times (again, for the first year of their honeymoon). I'm hoping to read about more research starting up in 2024 to confirm these results. Because Semaglutide is widely used to treat T2D and for weight loss, I think just one or two confirmation studies will be required to enable widespread use. If that gets us a year or two delay starting injections, that would be a huge win (and even more so if it could be combined with Teplizumab or other treatments).
Ladarixin is a drug being developed by Dompé. Ladarixin targets two specific immune system chemicals: IL-8a and IL-8b. I think it is the only research aimed at those targets, so it is a little unique. I'm interested in this because it is a phase-III trial. Those are large trials done only after results from phase-II trials. This one is being funded by the same company that did the phase-II trial, so they are really (in American terminology) "putting their money where their mouth is". That is the good news.
The bad news is that it usually requires two phase-III studies to get approval, and (as far as I know) this is the only phase-III trial done so far. Also, the results from the previous phase-II trial were not that strong. And finally, this trial is not going to be quick. They are gathering data for two years, which means the study will last at least two years after they finish recruiting, and they are still recruiting now. Therefore, we should not expect results before the end of 2025. However, even with all that, the company thought it was worth funding a large (300+ person) clinical trial, and that means that they have a realistic hope that it will be successful.
https://cureresearch4type1diabetes.blogspot.com/2023/05/dompe-starts-gladiator-phase-iii.html
Verapamil is another interesting "off label" drug. This is a drug which is already approved (since 1981) and widely used (3 million prescriptions a year) for high blood pressure. It is being tested on honeymooners. Therefore, if clinical trials show that it helps, it should be available quickly, especially for aggressive doctors who are willing to prescribe it off label.
Unfortunately, the ongoing study which was going to finish in 2024 is now going to finish in either 2025 or 2026, so we'll be waiting longer for results. I blogged about the start of this study here:
https://cureresearch4type1diabetes.blogspot.com/2022/02/verapamil-sr-starts-phase-ii-trial-ver.html
Diamyd is another drug in phase-III trials. They hope to finish in 2025, but the news we can look for is that their clinical trial is fully enrolled in 2024. If that happens, it puts them on track for results in 2025 or maybe 2026 in the worst case. Diamyd has a long complex history, but in the end, all that matters is results, and the news from 2024 will tell us if results will be coming in 2025 or 2026.
https://cureresearch4type1diabetes.blogspot.com/2023/12/diamyd-update.html
My Biggest Hope (Over More Than A Year)
All four of these treatments target honeymooners or pre-honeymooners, and they all seem to have different reasons they work. Therefore, it would be just wonderful if we could stack them. Use 2, 3, or even all 4 to delay the onset of T1D and then delay the need for injections, for many years.
Of course, success in established T1Ds would be even better, but I don't see that on the horizon for the next few years.
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