OPT101 is a peptide derived from mouse CD154. What does that mean? A peptide is a small part of a protein. CD154 is a protein found on some immune cells in both mice and people. CD154 is also called CD40L, but must not be mixed up with CD40. CD154 and CD40 work together to regulate parts of the immune system.
You can think of the immune system as being a large collection of different cells, often with CD or IL names. These cells interact in various ways to attack (or ignore) certain cells. Many immune responses are controlled by a balance between two different types of cells. This is the relationship between CD154 cells and CD40 cells. They balance each other so the the immune system is aggressive enough to attack foreign cells, but not so aggressive as to attack the body's own cells.
The researchers involved have been looking at the balance between CD154 and CD40 as part of the pathway to T1D for at least 20 years. There is a lot of research showing that CD154 (and the relationship between CD154 and CD40) is important to the path that leads to T1D. Therefore, it makes a lot of sense to test drugs that impact CD154.
The Clinical Trial
This is a Phase-I study of 18 people, but blinded, randomized, and placebo controlled study (so high quality). I think of it as the size of a Phase-I trial, but the design/quality of a phase-II trial. 2/3s of the people will get the OPT101 treatment, 1/3 a placebo. People in the study must be adults under 60 years old, who have had T1D for 20 years or less. This trial is for people with established T1D, not just honeymooners.
The study is divided into two groups, which differ by dosage. The second group will get about twice as much as the first group. Each group will have 6 people who get the treatment and 3 who get the placebo.
This study started in Sept-2022. The paperwork says they hope to finish by Oct-2022, but that is obviously a mistake. If they run both of their groups at the same time, they might be done by mid 2023, or by early 2024 if they run them one after the other.
They are currently recruiting at two locations on the US West Coast:
Contact: Lisa Boswell, MS 303-503-9954 LB@op-t.com
Diablo Clinical Research Center, Walnut Creek, California, United States, 94598
Contact: Meaghan Saint, PA-C, CDCES msaint@diablolclinical.com
Contact: Catherine Morimoto cmorimoto@diabloclinical.com
Rainier Clinical Research Center, Renton, Washington, United States, 98057
Contact: Sarah Holtz 425-251-1720 ext 309 sholtz@rainier-research.com
Contact: Tina Mitchell, RN 425-251-1720 ext 313 tinam@rainier-research.com
Discussion
Two quick points:
The thing I like most about this trial is, because they are gathering data for only 3 months, we will have results quickly.
Another company, Eledon Pharmaceuticals, is also targeting CD154 (which they refer to as CD40L), and they registered two clinical trials for AT-1501. However they withdrew the registration before the studies started, and in any case, they were targeted at helping islet cell transplants and not directly curing T1D.
More Information
Clinical Trial Registry: https://www.clinicaltrials.gov/ct2/show/NCT05428943
Company Web Site: http://op-t.com/
Background: https://www.frontiersin.org/articles/10.3389/fendo.2017.00208/full
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