January/February 2025 • PharmaTimes Magazine • 6

// TREATMENTS //


AlzeCure’s NeuroRestore ACD856 to be presented at AD/PD 2025

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AlzeCure Pharma AB announced that its abstract on NeuroRestore ACD856 has been accepted for presentation at the AD/PD 2025 conference.

The abstract will be presented by Gunnar Nordvall, Head of Chemistry at AlzeCure, in Vienna from April 1-5.

The abstract, titled Further investigation on the immunomodulatory and anti-inflammatory effects of NeuroRestore ACD856, will highlight the drug’s potential in treating Alzheimer’s disease. The data shows ACD856 affects biomarkers relevant to pathological neuroinflammatory processes.

“Our results show that ACD856 could have an effect on both central and peripheral inflammatory processes,” said Nordvall. “These new data are promising and further broaden the disease-modifying potential of ACD856, as neuroinflammation is an important part of the disease process in Alzheimer’s.”

Previous studies have indicated that NeuroRestore compounds improve cognitive abilities, including learning and memory functions. They also show neuroprotective and anti-inflammatory effects, with increased BDNF and NGF signalling.

“These positive results add to the case that NeuroRestore ACD856 could be relevant for additional indications with an inflammatory component, such as other neurodegenerative diseases,” said Martin Jönsson, CEO of AlzeCure Pharma AB.  “This further strengthens our commercial opportunities with ACD856.”

ACD856, AlzeCure’s lead drug candidate within the NeuroRestore platform, is being prepared for phase 2 clinical studies. The unique pharmacological mechanism of NeuroRestore enables multiple indications, including Alzheimer’s, Parkinson’s disease and depression.

The abstract includes contributions from Christina Parrado-Fernández, Veronica Lidell, Azita Rasti, Maria Backlund, Johan Sandin and Pontus Forsell from AlzeCure, and Ruchi Gera, Sumonto Mitra and Professor Maria Eriksdotter from Karolinska Institutet.

The international conference on Alzheimer’s, Parkinson’s and Related Neurological Diseases will provide a platform for presenting these promising preclinical study results.


EC approves lazertinib in combination with amivantamab for NSCLC patients

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The European Commission (EC) has approved the marketing authorisation for LAZCLUZE (lazertinib) in combination with RYBREVANT (amivantamab) for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with EGFR mutations.

Janssen-Cilag International NV announced this approval, marking a significant advancement in NSCLC treatment.

The approval is based on the phase 3 MARIPOSA study, which showed that the combination therapy demonstrated superior overall survival compared to the current standard treatment, osimertinib.

The study met its primary endpoint of progression-free survival, with median overall survival improvement expected to exceed one year.

“This chemotherapy-free regimen has already demonstrated significant progression-free survival improvements,” said Dr Antonio Passaro, medical oncologist at the European Institute of Oncology in Milan. “New topline data suggests it is expected to extend life by a median of one year or more, in patients with untreated EGFR-mutated NSCLC versus the current standard of care, osimertinib.”

Previously reported findings from the study showed that the combination of amivantamab and lazertinib had a manageable safety profile, with mostly grade 1 or 2 adverse events.

The most common treatment-emergent adverse events were paronychia, infusion-related reactions and rash.

“Today’s approval marks an important moment in lung cancer care,” said Henar Hevia, Senior Director, EMEA Therapeutic Area Lead, Oncology. “It brings a new option to patients through a chemotherapy-free regimen and potentially offers more time with their loved ones.”

This EC decision follows a corresponding approval in December 2024 for the bispecific antibody amivantamab, in combination with lazertinib, for the same indication.

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