Researchers usually call a trial "Phase-II" because it is larger than a Phase-I trial, and because it is focused on effectiveness while Phase-I trials are focused on safety. However, I have long been frustrated by two different types of Phase-II trials. Some Phase-II trials are run after a Phase-I trial. Generally, there was good news from the Phase-I trial, so it is reasonable to be hopeful about the follow on trial. However, other Phase-II trials are run on drugs which have already gone through safety testing for another disease. These trials are also called "Phase-II" because the treatment has already been tested for safety. However these treatments have never been tested for type-1 diabetes, so they are much less likely to be successful.
So there are Phase-II trials for treatments that have already shown some success in Phase-I trials, and then there are Phase-II trials for treatments which have never been tested on type-1 diabetes, but they both have the same name. I don't like that. So, I'm going to refer to these trials by different names.
Trials run after a Phase-I trial will be called Phase-II. Trials that are the right size for a Phase-II trial, but are being run on people with type-1 diabetes for the first time, will be called Phase-II? trials. You can think of the question mark as meaning "no previous type-1 results".
Ladarixin Starts a Phase-II? Clinical Trial
Ladarixin targets two specific immune system chemicals: IL-8a and IL-8b. The idea behind this trial is that suppressing this part of the immune system will stop the autoimmune attack which causes type-1 diabetes.
Ladarixin has previously been tested for several conditions unrelated to type-1 diabetes (Bullous Pemphigoid, Malignant Melanoma, and spinal cord injuries) but did not show promise in treating any of them. Adis Insight (a drug database) claims that a phase-I trial is underway in Italy, but I cannot find any official record of it, nor any results. (But European clinical trial registries often don't include Phase-I trials.) So for this posting, I'm assuming there is no phase-I trial. I'll update it if I find out about such a trial.
Ladarixin is also sometimes known as DF-2156A, DF-2156Y, or Meraxin. It is being developed by the Italian pharmaceutical company Dompé Farmaceutici.
The study will include 72 honeymooners (within 100 days of diagnosis). Two thirds will get the treatment and one third will get a placebo. The treatment is a daily pill, which people will take for two weeks, and then two weeks off with the cycle repeating three times. People will be followed for a year afterwards. The study started in June 2016 and they hope to finish by November 2018.
They are currently recruiting in two location in Italy:
- Internal Medicine - Diabetes and Endocrinology Unit, San Raffaele Hospital Milan
Contact: Emanuele BOSI, MD firstname.lastname@example.org
- Unità Operativa Complessa di Endocrinologia e Dialettologia. Università Campus Bio-Medico di Roma
Contact: Paolo POZZILLI, MD email@example.com
Needless to say, Ladarixin prevents and cures type-1 diabetes in mice, and you can read that study here: http://diabetes.diabetesjournals.org/content/early/2014/10/06/db14-0443
I'm not aware of any previous work suggesting that IL-8 is involved in type-1 diabetes, so this is a unique line of research.
Note that both trial registry entries refer to the same trial:
US Clincal Trial Registry: https://clinicaltrials.gov/ct2/show/NCT02814838
EU Clinical Trial Registry: https://www.clinicaltrialsregister.eu/ctr-search/search?query=2014-003968-20
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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.