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MS Trial Success Beats Industry Average

Parker, Jayson  Medical Biotechnology Analyst  Image Source: UNIVERSITYOFTORONTOMISSISSAUGA

But failure risk highest in progressive MS

Rates of clinical trial success in multiple sclerosis are nearly triple those in other disease areas, according to a review of compounds tested in MS over about 20 years.

More than a quarter of trials of MS drugs (27%) were successful, compared with the 10% industry-wide success rate, Jayson Parker, PhD, of the University of Toronto at Mississauga in Ontario, Canada, and colleagues reported online in Multiple Sclerosis and Related Disorders.

Small molecules did better than biologics, and novel drugs fared better than drugs previously approved for other indications outside MS, they found.

But there was also room for improvement -- two of the three late-stage failed trials occurred among drugs tested in progressive forms of MS.

"Multiple sclerosis is doing very well compared to other disease areas in terms of clinical trial risk management and that's fantastic," Parker told MedPage Today. "However, this can go further. 

Biomarker development, combined with patient history, has not seen much progress in MS and that is a key opportunity."

In the review, the investigators collected data on 53 candidate MS drugs tested in 58 phase I to phase III clinical trials from 1998 through 2015.

Overall, eight drugs went into phase III trials, and three of these eventually failed.

Of the three failures, two trials were done in patients with progressive forms of MS -- dirucotide in secondary progressive MS and Gilenya in primary progressive MS.

"The results of this study overwhelmingly reveal the sheer dearth and failure of clinical trials enrolling patients with progressive forms of MS," the researchers wrote.

They gave two possible explanations for the failure of progressive MS trials: a lack of understanding of the pathophysiology of progression, or premature progression from phase II to phase III trials.

Phase II clinical trials performed in relapsing MS were the most successful at predicting phase III clinical trial success, the researchers said.

The reasons why small molecules have a higher overall success rate than biologics are yet to be determined, but may reflect the drug technology or the target choice, they wrote.

"Considering the case that small-molecule MS drug success is a reflection of the superiority of the small molecule targets rather than the superiority of small-molecule drug technology, perhaps testing biologics aimed at small-molecule targets may further enhance success given the suggested superiority of the biologic technology," they wrote.

On the other hand, the ability of small molecules to cross the blood-brain barrier may explain their success, they noted.

"If this is the case, technology developed to increase the brain penetration and potency of monoclonal antibodies may therefore prove useful in MS," they wrote.

While conducting clinical trials in MS with drugs that have already been approved by the FDA should in theory reduce safety concerns, four of the seven trial failures of previously approved drugs turned out to be clinical rather than commercial failures, the researchers said.

"Our study found that testing drugs with previous FDA approval carried greater failure risk than testing new drugs specifically developed for MS," they wrote. "Prior FDA approval of drugs in an alternate indication does not confer a reduction in clinical trial risk for MS."

In an interview, Parker encouraged physicians to participate in clinical trials that explore innovative drugs with new mechanisms of action.

Physicians should also demand that biomarkers be explored in industry sponsored studies, Parker said. It is especially important "to insist on this in inclusion and exclusion criteria in phase II studies that are carried over to phase III studies," he told MedPage Today.

In addition, risk factors that are specifically relevant in MS need to be more rigorously identified, Parker said.

Story Source: The above story is based on materials provided by MEDPAGETODAY
Note: Materials may be edited for content and length


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