AlzeCure Pharma AB

AlzeCure Pharma is an innovative Swedish clinical stage Neuroscience biotech, listed at the Swedish Nasdaq. We develop develop first & best-in-class small molecules with projects within Alzheimer’s, cognitive disorders & pain, incl in orphan disorders. We have collaboration with Lilly on one of our Alzheimer's project that they have in licensed, and founding from the European Innovation Council.

We have two Alzheimer’s project, 1) NeuroRestore ACD856, a Trk-PAM which is in preparation for a ph 2 study in Alzheimer's patients, with the goal to improve learning and memory capabilities. The project, which also has disease-modifying potential, is co-funded by the European Innovation Council. This project also has potential within other cognitive disorders, as well as depression. Additionally, we have 2) Alzstatin ACD680 a gamma-secretase modulator. This project has been out licensed to Lilly, with whom we now have a collaboration with on this project.

PROJECTS

1. NeuroRestore, a novel symptomatic treatment for Alzheimer ́s disease & other disorders with cognitive dysfunction, but also with a strong potential within depression. This program focuses on the development of positive modulators of neurotrophic signaling such as those mediated by BDNF and NGF. The lead candidate ACD856’s upcoming ph 2 trial in Alzheimer’s Disease patients is co-funded by the European Innovation Council. NeuroRestore compounds have in preclinical models shown that they have potent procognitive properties as well as potential disease modifying abilities – the latter demonstrated by neuroprotective and anti-inflammatory effects, as well as enhanced synaptic health and mitochondrial function. The clinical candidate ACD856 is granted US, European, China & Japan patent until 2039, and an additional five years expected protection in the US.

2. ACD440 is a TRPV-1 antagonist for topical use aimed at peripheral neuropathic pain and with a granted orphan drug designation for the rare pain disorder erythromelalgia. The drug candidate has previously achieved positive ph2a results in patients with peripheral neuropathic pain with potent efficacy (50% pain reduction), as well as excellent safety and tolerability. For this project we have received orphan designation from the FDA and EMA for pain in Erythromelalgia. Now we are preparing for a ph 2b/3 study in Erythromelalgia, a study for which we have received positive feedback on from the FDA. We have an expected patent protection for the ACD440 product until 2041 and an additional five year protection in the US.

3. TrkA-NAM is a project where we have identified and developed peripherally restricted and highly selective negative allosteric modulators of TrkA for the treatment of pain , focusing on osteoarthritis. The lead molecule in the TrkA-NAM project, ACD137, has shown positive preclinical efficacy results both in neuropathic and nociceptive pain models, displaying both analgesic and anti-inflammatory effects. In a recent preclinical study in an osteoarthritis model, we showed that the analgesic effect was on par with the anti-NGF antibody Tanezumab, but had additional protective effects on the knee joint. The project has received increased attention since Asahi Kasei is in ph 2B in osteoarthritis with their TrkA-NAM compound AK1830, with an expected readout in 2026. Our lead molecule in the TrkA-NAM project, ACD137, is believed to be a potential best-in-class molecule.