Current Research into Cures for Type-1 Diabetes: Alba Therapeutics

Thursday, September 24, 2009

Two Possible Cures go to the Boneyard

It's never good news when possible cures "go to the boneyard", but it is part of research. Some treatments work and many don't. Here is a little discussion of two treatments, one of which has not worked out (for type-1 diabetes), and the other is on hold, with no clinical trials in sight:

Transition Therapeutics's TT-223 goes to the Boneyard

Transition Therapeutics is researching using a combination of two drugs to cause beta cell regrowth in an attempt to cure type-1 and type-2 diabetes. As of May 2009, they had officially marked their phase-I human trial for type-1 diabetes as closed. I haven't seen any published results for it, but I'm still looking. However, actions speak louder than words, and Eli Lilly (working with Transition Therapeutics) started a clinical trial in February 2009 using Transition Therapeutics's TT-223 product, but only for people with type-2 diabetes.

Also, in May 2009 they announced that JDRF and Transition Therapeutics had agreed that JDRF would stop funding clinical development of TT-223. Transition Therapeutics and JDRF terminated their agreement. Eli Lilly is taking over support for TT-223, but is applying the technology only to type-2 diabetes.

So the news from Transition Therapeutics for type-1 diabetics is not good. I will move Transition Therapeutics to my "boneyard" of research that has not panned out if there is no good news in the next 6 months.

Discussion

This result is not too surprising, and is similar to previous results with INGAP: because type-1 diabetes is an autoimmune disease, simply regrowing new beta cells can not cure it. The immune system attacks the new beta cells the same as the old ones. This type of treatment has more direct applicability on type-2 diabetes, where more beta cells are more likely to be helpful. Of course, if any of the treatments currently being developed succeeds in ending the autoimmune attack, then treatments that regrow beta cells will suddenly be in high demand. Unless the body regrows beta cells naturally without intervention.

A few months after stopping the funding of TT-223, JDRF started funding a large, general program (together with Genomics Institute of the Novartis Research Foundation) to test generic drugs for their ability to help regrow pancreas cells. Although I don't have visibility into JDRF's decision making, I think it is reasonable to say that since TT-223 did not pan out, JDRF is putting money into other research with similar goals. Unfortunately, that research is not in human trials yet, so I won't be following it.

These are records for Transition Therapeutics's phase-I studies:
http://clinicaltrials.gov/ct2/show/NCT00239148 (type-1)
http://clinicaltrials.gov/ct2/show/NCT00239187 (type-2)

And here is the clinical trial record for their phase-II study (which is type-2 only):
http://clinicaltrials.gov/ct2/show/NCT00853151

I'd like to thank Susan Mohr for some of the information used here.

Alba's Lazotide (previously AT-1001) goes to the Boneyard for type-1 diabetes, but not Celiac Disease

I recently moved Alba Therapeutics's Larazotide (previously known as AT-1001) from my "preparing for clinical trials" section to my "boneyard" for treatments that are no longer under development as cures for type-1 diabetes.

I did this before reading the following Scientific American article:
http://www.scientificamerican.com/article.cfm?id=celiac-disease-insights
That article (written by a founder of Alba Therapeutics) says that the FDA approved human trials for Larazotide for type-1 diabetes. However, I can not find any references at the company's web site that they are planning such a clinical trial, and there is nothing in www.clinicaltrials.gov, either. So therefore it is staying in the boneyard for now.

If you read the article linked above, remember that the author did some of the original research into Larazotide and founded Alba Therapeutics, so is not an unbiased source! In particular, this quote:

Surprisingly, essentially the same trio—an environmental trigger, a genetic susceptibility and a “leaky gut”—seems to underlie other autoimmune disorders as well. This finding raises the possibility that new treatments for CD may also ameliorate other conditions.

This is the author's opinion, however I don't think it is general consensus among researchers. Most researchers believe that autoimmune disorders are built on a foundation of a genetic susceptibility and an environmental trigger. The idea that "leaky gut" underlies autoimmune disorders is a minority opinion. Of course, if Larazotide works the way Alba hopes it will, that might change.

All of the above comments pertain to using Larazotide for type-1 diabetes, not Celiac Disease. The situation for Celiac is much different: Alba is running human trials. There are several listed at www.clinicaltrials.gov, and I think some of them are phase-II. (But I don't follow Celiac closely so am unclear on the details. Also, there appear to be two different drugs called "AT-1001" and "AT1001" so don't get confused.)

Joshua Levy

My Non-Conflict of Interest Statement

For the first 10 years of running this blog, I did not work for a company doing medical research. In 2018, I started working for Bigfoot Biomedical, which is developing an "automated insulin dosing/delivery solution" (what many call an Artificial Pancreas).
I blog on research aimed at curing type-1 diabetes, and I view Bigfoot Biomedical's work as treating type-1 diabetes (not a cure at all). Therefore, I don't view this work as conflicting with my blogging. However, if you consider the kind of automated insulin dosing/delivery solution that Bigfoot is developing to be an actual cure for type-1, then this would conflict with my blogging. I think they are quite different.
I don't get paid in any way by any company working on a cure for type-1 diabetes; I never have. And that includes free samples, free travel, or free anything. I do sometimes participate in market research studies or focus groups, and they sometimes pay.
None of the hours that I have put into my blog, or the posts that I make to any web site, has ever been paid for. (Except for some very nice and heart felt thank-you emails, and those are worth more than money.)
My daughter has type-1 diabetes and participates in clinical trials. I sometimes report on trials that she participates in, but I do not reveal her participation because I consider her medical history to be private.
I sometimes "beta test" new software or devices involved in type-1 diabetes. When I'm blogging about something where I have been given special access, I say so.
In the past I have volunteered with JDRF and The NIIB Project. I currently am a fellow with JDCA. The JDRF and NIIB work was completely unpaid. JDCA has given me equipment that I use to help my blogging, and on one occasion paid for specific consulting work.