Quantum BioPharma Ltd. (NASDAQ:QNTM) saw its shares rise in premarket trading after the company announced that patient enrollment in its collaborative study with Massachusetts General Hospital reached the midpoint and that initial imaging results were encouraging.
The clinical study aims to validate a positron emission tomography - PET - imaging approach that can directly identify demyelinated neurons that nonetheless retain intact axons, and to monitor demyelination in people with multiple sclerosis. The investigation uses the PET tracer [18F]3F4AP, which was developed by Pedro Brugarolas, an investigator in the Department of Radiology at MGH and an Assistant Professor at Harvard Medical School.
Quantum reported that the first cohort of study participants has been imaged successfully on both advanced PET/MR and total-body PET platforms. Preliminary analyses provided by the company indicate a robust signal in acute MS lesions and suggest potential sensitivity to gray matter lesions.
"We are excited to reach this important midpoint in our study with MGH and encouraged by the strength of the preliminary imaging data," said Dr. Andrzej Chruscinski, Vice-President, Scientific and Clinical Affairs at Quantum BioPharma.
The company said the imaging technique could permit more precise measurement of how therapies affect myelin preservation and regeneration. That capability could enhance evaluation of investigational treatments, including Quantum BioPharma's Lucid-MS (Lucid-21-302).
Lucid-MS is described by the company as a neuroprotective candidate that seeks to inhibit demyelination by targeting protein arginine deiminase 2 - PAD2 - an enzyme the company links to myelin degradation. Quantum submitted an Investigational New Drug - IND - application to the U.S. Food and Drug Administration seeking Phase 2 approval in March 2026.
Earlier Phase 1 clinical trials of Lucid-MS showed a favorable safety profile and the drug was reported to be well-tolerated in healthy volunteers, according to the company. The current imaging study with MGH is intended to validate an imaging biomarker that could improve assessment of myelin-targeted therapies' biological effects.
With enrollment at the study's midpoint and initial imaging reads described as promising, Quantum highlighted both the technical performance of the imaging platforms used and the tracer's signal characteristics in acute lesions as noteworthy interim observations. The company did not provide additional efficacy results for Lucid-MS in patients with multiple sclerosis as part of this update.
Further data and continued enrollment will determine whether the preliminary imaging findings hold as the study progresses beyond its midpoint.