AlzeCure Pharma

About AlzeCure Pharma AB (publ)

AlzeCure® is a Swedish pharmaceutical company that develops new innovative small molecule drug therapies for the treatment of severe diseases and conditions that affect the central nervous system, such as Alzheimer’s disease and pain – indications for which currently available treatment is very limited. The company is listed on Nasdaq First North Premier Growth Market and is developing several parallel drug candidates based on three research platforms: NeuroRestore®, Alzstatin® and Painless.
 
NeuroRestore consists of two symptomatic drug candidates where the unique mechanism of action allows for multiple indications, including Alzheimer’s disease, as well as cognitive disorders associated with traumatic brain injury, sleep apnea and Parkinson’s disease. The Alzstatin platform focuses on developing disease-modifying and preventive drug candidates for early treatment of Alzheimer’s disease and comprises two drug candidates. Painless is the company’s research platform in the field of pain and contains two projects: ACD440, which is a drug candidate in the clinical development phase for the treatment of neuropathic pain, and TrkA-NAM, which targets other types of severe pain in conditions such as osteoarthritis. AlzeCure aims to pursue its own projects through preclinical research and development through an early clinical phase and is continually working on business development to find suitable solutions for license agreements with other pharmaceutical companies.
 
FNCA Sweden AB is the company’s Certified Adviser. For more information, please visit www.alzecurepharma.se

About NeuroRestore
NeuroRestore is a platform of symptom-relieving drug candidates for disease states in which cognitive ability is impaired, e.g. Alzheimer’s Disease, sleep apnea, traumatic brain injury and Parkinson’s disease. NeuroRestore stimulates several important signaling pathways in the brain, which among other things leads to improved cognition. In preclinical studies with NeuroRestore, we have been able to show that our drug candidates enhance communication between the nerve cells and improve cognitive ability. NeuroRestore stimulates specific signaling pathways in the central nervous system known as neurotrophins, the most well-known being NGF (Nerve Growth Factor) and BDNF (Brain Derived Neurotrophic Factor). The levels of NGF and BDNF are disturbed in several disease states and the signaling is reduced. The impaired function impairs communication between the synapses, i.e. the contact surfaces of the nerve endings, as well as reducing the possibility of survival for the nerve cells, which gives rise to the cognitive impairments. Neurotrophins play a crucial role for the function of nerve cells, and a disturbed function of BDNF has a strong genetic link to impaired cognitive ability in several different diseases, such as Alzheimer’s, Parkinson’s disease, traumatic brain injury and sleep disorders. There is also a link between BDNF signaling and depression, something that has been further strengthened in recent years.
In addition to cognitive-enhancing effects, new preclinical data also show that NeuroRestore substances have a positive effect on mitochondrial function and cell survival, which could indicate potential disease-modifying effects.
The leading drug candidate in the platform, ACD856, has recently completed phase I clinical studies and has shown positive effects that support continued development of the program.

About Alzstatin
AlzeCure’s disease-modifying research platform, Alzstatin, consisting of disease-modifying and preventive drug candidates, focuses on reducing the production of toxic amyloid beta (Aβ), such as Aβ42, in the brain. Aβ42 plays a key pathological role in Alzheimer’s and begins to accumulate in the brain years before clear symptoms develop. The drug candidates in the Alzstatin platform modulate the function of the enzyme gamma secretase. Gamma secretase acts like a pair of scissors and cuts Aβ42 out from a longer protein known as APP. The sticky Aβ42 clumps together giving rise to the amyloid plaque so typical of Alzheimer’s disease. The candidates in the Alzstatin platform affect enzyme function so that it instead cuts out shorter forms of the Aβ peptide, Aβ37 and Aβ38, which in addition to them not being sticky and not forming aggregates, also have a restrictive effects on Aβ42 aggregates already formed. This means the drug candidates in the Alzstatin platform have two separate but synergistic effects that together contribute to a stronger anti-amyloidogenic – and thus more potent – disease-modifying effect. This specific mechanism of action differentiates it from biological therapies, e.g. antibodies. Moreover, small molecules such as Alzstatin, have several other advantages, including easy and non-invasive administration as tablets or capsules. Small molecules will also generally pass more readily through the blood-brain barrier to reach its target, the brain.

About ACD440
ACD440 is a TRPV1 antagonist that is in the clinical development phase, and the company's aim is to develop a new topical local treatment for neuropathic pain. Neuropathic pain affects a total of approximately 7–8 percent of the adult population, which means approximately 600 million people globally. The market is characterized by a large medical need, where approximately 70-80 percent of patients do not receive effective pain relief with existing treatment.
The ACD440 project originates from Big Pharma and is based on a strong scientific foundation. The discovery and insight into TRPV1, the biological system that underlies ACD440 and is central to, among other things, temperature regulation and pain, was awarded the Nobel Prize in Physiology or Medicine in 2021. The substance, which is being developed as a gel for the local treatment of peripheral neuropathic pain, has previously undergone clinical studies, but then as an oral treatment. According to plan, AlzeCure was able to initiate a clinical phase Ib study with the drug candidate at the end of 2020, which read-out in April 2021 and showed positive proof-of-mechanism results, i.e. an analgesic effect in humans. During quarter 1 2022, feedback was received from the FDA on the material and documentation submitted for a preparatory pre-IND meeting. The response was informative and the company has now initiated a phase II study with ACD440 in patients with peripheral neuropathic pain in June 2022. Results from the study are expected in mid-2023.

About TrkA-NAM
The TrkA-NAM project, which is in research phase, is aimed at treatment of osteoarthritis pain and other severe pain disorders and has strong preclinical and clinical validation. For this drug project, we have leveraged our knowledge concerning the underlying biology for the NeuroRestore platform in order to develop new compounds that focus on providing pain relief in conditions associated with severe pain. The goal of the project is to develop a small-molecule TrkA-negative allosteric modulator for the treatment of osteoarthritis pain and other severe pain disorders. The global osteoarthritis market is expected to reach USD 11.0 billion by 2025, from USD 7.3 billion in 2020. Growth in this market is driven by factors such as the increasing occurrence of osteoarthritis, the growing aging population, and an increase in the number of sports injuries. Over 240 million people worldwide suffer from painful and activity-limiting osteoarthritis of the hip or knee. Many patients experience insufficient pain relief or side effects with current treatment, which today usually consist of NSAIDs or opiates and there is a great need for more effective and better tolerated drugs in this field.