A receptor is a part of the body’s cells that can receive particular body chemicals, such as hormones or neurotransmitters. This is how the body “communicates” with itself. When one chemical attaches to a receptor, it triggers the release of additional chemicals in a particular chain 🔗
S1P1 is a receptor involved in immune-system modulation. Lupus experts suspect that modulating the activity of this receptor will provide benefit for the management of systemic lupus erythematosus (SLE).
Cenerimod offers new hope as compared to other immune system suppressing drugs because it uses a novel mechanism of action. It blocks the release of lymphocytes, a subtype of white blood cell found in the immune system.
Current research has focused on adults. But, the results are promising. Company representatives presented their work at the 2019 American College of Rheumatology Annual Conference. And, Idorsia received a Fast Track designation from the FDA to support the development and potential approval of the drug.
Understanding the clinical trial process
Clinical trials are a process to ensure both safety and efficacy of new medications. These clinical trial steps are known as phases.
The Phase 1 study showed that Cenerimod was able to lower the amount of lymphocytes. It was also able so sustain the decrease.
Next, the Phase 2 study evaluated dosages and compared the medication effect to a placebo. Some adverse events occurred including decreased pulmonary function. But, the results of the study were promising. Cenerimod reduced lymphocytes at the various dosages. Lymphocyte production returned to normal levels when the medication was discontinued.
A deeper look at the methods
The study design for the Phase 3 trial is:
- The study occurs at more than one medical center or institution.
- This is important for researching rare diseases like lupus, as it allows the trial to reach people where they live and doesn’t require undue travel. The lack of centralization can make organization difficult.
- Participants assigned to their group randomly
- In a blinded trial, participants do not know whether they were given the trial’s treatment or placed into the control group.
- In a double-blind, neither the researchers nor the participants know who is in the treatment or control group until the study is over. This practice helps to eliminate any effect that the researcher’s behavior may have on the results.
- A placebo is a non-active compound with a similar route of delivery as the medication. For Cenerimod, an orally taken drug, the placebo would also be taken by mouth.
- Placebo studies may include “standard of care” comparisons. Participants remain on their current treatment plan and receive the new medication as an add on.
- Comparisons can also be made to a similar drug that does similar things in the body, to see if the new treatment is more effective (or less dangerous).
- Parallel Group
- One group takes the treatment and the other group takes the control. Less commonly, you can have “crossover” trials, where the two groups undergo the same treatments – but in a different order.
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