ProMIS Neurosciences Inc. (NASDAQ:PMN) shares gained 13% on Tuesday after the company released encouraging six-month interim safety and biomarker data from its ongoing PRECISE-AD Phase 1b study evaluating PMN310 in patients with Alzheimer’s disease.
The clinical-stage biotechnology company reported favourable blinded interim findings, highlighting a strong safety profile and biomarker trends that support continued development of the investigational therapy.
Interim Analysis Shows Favourable Safety Profile
The blinded interim analysis included 136 patients with Alzheimer’s disease and found no cases of amyloid-related imaging abnormalities with oedema (ARIA-E) across any genetic subgroup, including APOE4 homozygotes.
Overall ARIA incidence was 4.4%, with all reported events classified as mild, asymptomatic amyloid-related imaging abnormalities-microhaemorrhages (ARIA-H).
The company also reported no treatment-related serious adverse events and no study discontinuations linked to the investigational drug.
Among trial participants, 61% were APOE4 carriers, including 11% who were APOE4 homozygotes. PMN310 is being studied in patients with mild cognitive impairment caused by Alzheimer’s disease or those with mild Alzheimer’s disease.
Biomarker Trends Support Continued Development
Blinded interim biomarker data showed that 68.5% of patients experienced a reduction from baseline in plasma pTau217, while 62.5% recorded lower cerebrospinal fluid MTBR-tau243 levels.
ProMIS said these findings are consistent with the study’s 3:1 randomisation of active treatment versus placebo but stressed that the blinded biomarker results should not be interpreted as evidence of clinical efficacy.
PMN310 has been designed to selectively target toxic amyloid-beta oligomers while avoiding amyloid plaque, an approach intended to separate potential therapeutic benefits from the risk of ARIA that has affected other amyloid-targeting treatments.
Topline Results Expected in Early 2027
The PRECISE-AD trial remains fully blinded and continues to enrol and monitor participants.
ProMIS expects to report topline 12-month results during the first quarter of 2027.
“These interim data reinforce our central thesis: by selectively targeting toxic oligomers, PMN310 has the potential to deliver the benefits of amyloid-directed therapy without the ARIA burden that has constrained this class of drugs,” said Neil Warma, Chief Executive Officer of ProMIS Neurosciences.
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