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BY KATIE O’CONNOR, Richmond Times-Dispatch
In 50 years, only one treatment was approved by the U.S. Food and Drug Administration to treat lupus, an autoimmune disease in which a person’s immune system attacks their healthy organs and tissue.
Because there are so few drugs on the market specifically for them, the only options for lupus patients are oftentimes drugs made for other diseases, such as malaria and cancer.
One of the obstacles to getting any new drug on the market is the length of time it takes to go through the clinical trial process before a drug is approved by the FDA. It can take upwards of 10 years before a drug has gone through the proper trials.
A company in Charlottesville, AMPEL BioSolutions, is attempting to make the clinical trials easier for patients and hopefully speed up the process.
“One of the issues in clinical trials is that they’re actually quite difficult for the patients because patients have to come to a clinical site frequently, and the only information that’s really collected is information at the clinical site, but a lot of things can happen to patients between visits,” said Dr. Peter Lipsky, AMPEL’s CEO and chief medical officer who, along with Amrie
Clinical trials can help prove a drug’s viability, but they also serve as opportunities for people who have few medication choices — such as lupus patients — to try something new that might help them.
AMPEL’s technology — a combination of an app and smartwatch — tracks how a patient is doing at home and in real time. It was developed along with Carematix, a wellness monitoring company, and is currently being used in a study to address fatigue in lupus.
The app and watch collect the patient’s reported outcomes, such as how often they’re moving, their pain, fatigue and other factors without visiting a clinician’s office.
“The hope is that by collecting all this information, we’ll be able to have a much better idea of how the patient is responding to all the interventions and perhaps get a much better and more comprehensive way to determine the overall impact of the medication and specifically whether the medication is positively affecting those signs and symptoms that the patients are most worried about,” Lipsky said.
Patients are enrolling in the clinical trials now. The trials will last for about six months and take place in 20 centers around the country. AMPEL is involved in about six lupus trials with various interventions.
Lipsky and Grammer hope that the data collected from the process could help provide quicker answers as to whether the interventions really work.
“There are a very large group of individuals with autoimmune, inflammatory diseases that haven’t had any new therapies for a very long period of time, and patients are really struggling with some of the older therapies,” Lipsky said. “We hope we can help to bring some relief to many patients.”