Researchers in Australia are exploring a new method of drug delivery that harnesses the power of teenage acne.
The same bacteria that can fill an adolescent with anxiety over a face full of blemishes may become a tool for treating secondary progressive multiple sclerosis (SPMS).
“The study is taking place at four sites around Australia,” Bob Soh, Ph.D., from the Nucleus Network in Melbourne, told Healthline. He is lead investigator for the Melbourne study site and oversees recruitment, enrollment, and execution of the trial.
A Germ of Hope for Progressive MS
Researchers want to know how effective the new drug, called MIS416, is for treating SPMS. Although there are currently 12 FDA-approved drugs for relapsing-remitting MS (RRMS), there are no treatments for progressive forms of the disease.
Soh, along with the other investigators, hopes the experimental drug, which contains a refined version of acne-causing bacteria, will trip a switch and turn on the signaling pathways of the innate immune system to combat disease activity in MS.
The bacteria that cause pimples, Propionibacterium acnes (P. acnes), have cell walls that are rich in muramyl dipeptide, a protein that triggers the NOD2 pathway in the body’s innate immune system, explained Soh.
“We are trying to target two innate immunity pathways with both [P. acnes] and MIS416,” said Soh. “The benefit of using this approach is that the immune system will take up this bacteria, ensuring direct uptake of both MIS416 and Propionibacterium directly into the immune system where it is designed to target.”
So, by turning on these pathways with P. acnes, the door is flung wide for the experimental MIS416 to do its job.
The study’s sponsor, Innate Immunotherapeutics, has developed a special manufacturing process to treat the acne-causing bacteria that removes all but the active microparticle necessary to trigger the immune response.
Early Trials Yield Positive Results
Early-stage clinical trials typically use a small sample of volunteers in order to determine the safety and effectiveness of a treatment.
In this phase of the study, 90 participants with SPMS will receive a weekly infusion of either MIS416 or a placebo for 52 weeks.
After that time, the volunteers who had been on placebo will be given the opportunity to switch to MIS416.
In an earlier study of 10 patients, eight of the volunteers showed a 30 percent or greater improvement in at least one measure of their neuromuscular function. These earlier, positive results prompted the researchers to forge ahead with the larger study.
Volunteers undergo a battery of tests to measure the state of their disease, including the MS Functional Composite that consists of a timed 25-foot walk, a 9-hole peg test, and the Paced Auditory Serial Addition Test, where patients add a series of numbers as they hear them to test their cognitive ability. Grip strength and vision are also tested.
According to the National Multiple Sclerosis Society, most people who are diagnosed with RRMS will eventually transition to SPMS. So researchers like Soh and others realize how critical it is to find treatments for those who are no longer relapsing.
“Preventing relapses is a goal in [RRMS] whereas in [SPMS] ongoing accumulation of disabilities is no longer associated with relapsing pathology,” said Soh.
MIS416 is in development for SPMS and, as Soh explains, the goal of the study is “to slow or stop progression and perhaps, based on patient reporting to date, also to reverse some of the disabilities and other symptoms associated with MS.”
Soh is hopeful this larger study will benefit those with primary progressive MS (PPMS) too.
“The sponsor has some anecdotal data from patients with primary progressive MS that MIS416 may have some positive effect in that form of MS as well, although the patients with PPMS have not reported the degree of improvements that many patients with SPMS have reported,” said Soh. “Given the unmet need in both SPMS and PPMS, the sponsor is currently very focused on establishing to what extent MIS416 can impact progressive MS disease.”
To learn more about this study or find out if you’re a likely candidate, read more here.