Secukinumab and Ustekinumab have a lot in common, including both starting phase-II trials in the last few months, so I'm covering them together. Both of these drugs are monoclonal antibodies, meaning they are specifically targeted at one kind of immune cell. (Approximately 1/3 of all new drugs in the US are monoclonal antibodies, so this is not unusual.) In both cases the drugs have already done phase-I trials for other diseases, so the phase-II trials described here are the first times these drugs have been tested on type-1 diabetes.
Soundtrack for this blog posting: http://grooveshark.com/#!/s/The+Chain/1Ty1wz
This drug has been submitted to the FDA for approval for treating moderate-to-severe plaque psoriasis (an autoimmune disease), but has not yet been approved. It has also been tested for some other autoimmune diseases. Secukinumab is thought to work by blocking inflammation, specifically blocking IL-17, an immune molecule. Secukinumab was known as AIN457 during development.
The trial has started recruiting, and is expected to run until April 2019, enrolling 100 people. Half will get the drug, half will be in a placebo group (randomized, double blind). The primary end points are safety and C-peptide generation after a meal. Secondary end points include A1c, insulin usage, etc. This study is funded by Novartis Pharmaceuticals. They are recruiting people at least 15+ locations all over the US. Unfortunately, none of them are in the San Francisco bay area.
Clinical Trial Record: http://clinicaltrials.gov/ct2/show/NCT02044848
This drug was approved in the US in 2009 for treating psoriasis, which is an autoimmune disease (where the immune system self attacks skin cells rather than pancreas cells, as with type-1). It has also been tested on multiple sclerosis, Crohn's disease, and sarcoidosis (also all autoimmune diseases). Ustekinumab is thought to work by blocking inflammation, and specifically blocking two immune molecules called IL-12 and IL-23.
This trial will run from July 2014 to March 2016, and will enroll 20 people, in 4 groups of 5 people. There is no control group; each group will get a different dose of the drug. The primary end points are all safety related, the secondary endpoints are all immunology related, but there are "exploratory" endpoints which are the results a person with type-1 would care about: C-peptide measurements, insulin usage, and A1c. The study is being done at the University of British Columbia, by a professor in their dermatology department. I assume he has experience with the drug's use on psoriasis. It is funded by JDRF.
Clinical Trial Record: http://clinicaltrials.gov/ct2/show/NCT02117765
These studies brought up two points for me:
First: They show the power of money and capitalism in getting research done. The JDRF (a non profit) is funding the Ustekinumab study, and they can only afford to dose 20 people (no placebo group). On the other hand, the Secukinumab study is funded by industry, and they are dosing 50 people and in addition have a full placebo group. It is nice to have money.
Second; conspiracy theorists will need to ignore the Secukinumab study, because it doesn't fit with their "corporate America is making too much money to cure type-1" theory. That study is being funded by Novartis Pharmaceuticals, which makes a huge amount of money off diabetics. It is a classic "Big Pharma" company, yet here it is funding a drug that might be a cure for type-1. Why? Because they think they can make more money faster by curing type-1, than by treating it. And they are afraid that if they don't, someone else will, and they'll be left with nothing. The other company will get all the money from the cure, and they will be left with no one to treat. Die hard conspiracy theorists will say "they're funding the trial just to bury it", but if that were true, why fund it at all? Running a human trial in the US right now, requires public disclosure. If they really wanted to run some secret trial, they'd be doing it in Russia, China, or some country that didn't have public registry requirements.
publicjoshualevy at gmail dot com
All the views expressed here are those of Joshua Levy, and nothing here is official JDRF, JDCA, or Tidepool 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.