ProJenX ALS treatment gets back on the map after partial FDA hold

ProJenX is back on the map after the FDA lifted a partial clinical hold on a phase 1 clinical trial for an amyotrophic lateral sclerosis (ALS) drug.

The MAP4 kinase (MAP4K) inhibitor prosetin was set to be tested in an early-stage trial called PRO-101 with healthy volunteers and patients who have ALS. While the volunteer portion has completed, the regulator stepped in to halt Part 1c of the trial.

Now, ProJenX can get moving on dosing patients with ALS. The company did not say when the hold had been applied or provide an explanation of the FDA’s concerns. Requests for comment on those details went unreturned as of publication.

"Following recent clinical trial application authorizations in Canada and Europe, we are very pleased that FDA has lifted this partial clinical hold, which previously limited prosetin dose levels in study PRO-101 in the U.S.," ProJenX Chief Operating Officer Erin Fleming said in a Thursday release. "The FDA's decision allows us to fully pursue a global strategy to bring this promising investigational treatment to people with ALS and other neurodegenerative diseases."

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Canadian and European regulators okayed the trial in November 2023 and February, respectively.

Prosetin was discovered by researchers at Columbia University, who went on to form ProJenX to examine the drug in ALS. MAP4K inhibition is believed to provide motor neuron protection across multiple patient stem cell-derived models of ALS. So, prosetin was developed to be a potent inhibitor of the pathway with efficacy in motor neuron rescue and preferential distribution to the central nervous system.