Significant Phase 3 results for the Belgian-Spanish biotech company Minoryx

The Belgian-Spanish biotech company Minoryx Therapeutics disclosed on Monday, February 15th,  the results of its Phase III clinical study to evaluate its drug candidate, leriglitazone, in adrenomyeloneuropathy (AMN), a neurodegenerative orphan disease leading to severe motor disorders that can lead to paralysis.

The primary endpoint for the drug candidate leriglitazone was the observation of a change from baseline in a 6-minute walk test.

Verdict of this clinical trial: many significant improvements in patient outcomes, but one primary endpoint was not met. Conducted with 116 patients, this pivotal multicenter, double-blind, placebo-controlled study showed that leriglitazone “significantly reduced the progression of brain damage and myelopathy-related symptoms,” such as loss of balance, according to Minoryx.

There is an improvement in the quality of life of patients and the improvements seen are greater in patients with more recent disease, said the biotech company based near Barcelona, which has a branch in the Gosselies Biopark.

The only downside is that the primary endpoint was not met. It was the evaluation of a change from baseline in a 6-minute walk test.

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What lessons can be learned from these results? 

Simply put, Minoryx hopes that this will not be a barrier to the further process of bringing its treatment to market, given the other important benefits that have been achieved. “If you look at all the data obtained, it is clear that the drug has had a positive effect on these patients and has shown significant clinical benefits in multiple parameters ranging from myelopathy-related symptoms to the progression of brain damage,” said Marc Martinell, Minoryx’s CEO, in L’Echo.

“This specific outcome of the primary endpoint can be easily explained if we consider the date the study was initiated. When we started the trial 4 years ago, the understanding of the data on this disease and its natural history was extremely limited. This is the main reason why the primary endpoint was not met for the whole population,” added the CEO.

A solid foundation

So don’t worry, according to the Minoryx boss. “I don’t think this threatens the future of leriglitazone, quite the contrary. We are convinced that these results will provide a solid basis on which we can build a development path so that leriglitazone can finally be offered to patients. We will discuss this with the regulatory authorities in the near future.”

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First published in L’Echo, a third-party contributor translated and adapted the article from the original. In case of discrepancy, the original will prevail.

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