Press release

AlzeCure Pharma broadcasts live event about the phase II candidate ACD440 against neuropathic pain

AlzeCure Pharma AB (publ) (FN STO: ALZCUR), a pharmaceutical company that develops candidate drugs for diseases affecting the nervous system, focusing on Alzheimer's disease and pain, today announced that the company arranges a live event on October 23 at 1 p.m. with Dr. Rolf Karlsten as invited guest speaker.

During the symposium, titled "ACD440 - A novel non-opioid analgesic", Dr. Karlsten will provide an overview of the area of pain. Märta Segerdahl, CMO and project manager, will also give an update on AlzeCure's clinical phase II candidate, ACD440, which is being developed as a new topical treatment for patients with chronic neuropathic pain. In addition, Dr. Karlsten, together with AlzeCure's CEO Martin Jönsson and CMO Märta Segerdahl, will answer questions about the company's progress in the development of new pain treatments.

ACD440 is a first-in-class TRPV1 antagonist in clinical phase being developed as a new topical local treatment for peripheral neuropathic pain. The drug candidate, which was incorporated via strategic in-licensing, originated in Big Pharma and is based on a strong scientific foundation, which was awarded a Nobel Prize in 2021. The substance is developed as a gel for topical use, which keeps the systemic exposure very low while the local concentration of the substance can be kept high to achieve a maximum analgesic effect, as well as over a long period of time.

In 2023, AlzeCure reported positive proof-of-mechanism results (PoM) with ACD440 in patients with chronic peripheral neuropathic pain, i.e. the drug candidate had an effect on the intended target mechanism, and a clear and significant analgesic effect was observed on pain induced by cold and heat. This pain was reduced by approximately 50%, a significant and clinically relevant reduction. Temperature hypersensitivity is very common in the skin area where the patients have their neuropathic pain, and is a major problem in everyday life for these individuals. These positive PoM results from this phase II study were in line with previously reported phase I results. Furthermore, it was observed that ACD440, given as a topical gel applied to the skin in the area of pain, was well tolerated and both the substance and the route of administration show good suitability for further clinical development.

Agenda:
13:00 – Introduction to AlzeCure and today’s agenda – Martin Jönsson, CEO AlzeCure
13:10 – Pain: background and medical needs – Rolf Karlsten, MD, PhD, Uppsala University Hospital
13:30 – ACD440: A novel non-opioid analgesic – Märta Segerdahl, MD, PhD, CMO, AlzeCure
13:45 – Q&A
14:00 – Final comments – Martin Jönsson, CEO AlzeCure

The event is held in English and takes place in collaboration with Finwire, does not require advance registration and can be followed via: https://www.finwire.tv/webcast/alzecure-pharma/acd440-a-novel-non-opioid-analgesic/

The presentation will also be available afterwards on AlzeCure's website https://www.alzecurepharma.se/en/presentations-and-interviews/ and on the company's YouTube channel: https://www.youtube.com/@alzecurepharma5138.

About AlzeCure Pharma AB (publ)

AlzeCure® is a Swedish pharmaceutical company that develops new innovative 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 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 outlicensing solutions with other pharmaceutical companies.

FNCA Sweden AB is the company’s Certified Adviser. For more information, please visit www.alzecurepharma.se.

About neuropathic pain
Neuropathic pain affects approximately 7–8 percent of the total global adult population, approximately 600 million individuals. Some patients, with indications such as diabetes and HIV, are affected to a greater extent, where approximately 25 and 35 percent respectively of the patients experience neuropathic pain.

Peripheral neuropathic pain is the result of various types of damage to the nerve fibers, such as toxic, traumatic or nerve compression injuries as well a metabolic and infectious diseases. Common symptoms are painful tingling that can be described as “pins and needles”, or choking or burning pain, as well as the feeling of getting an electric shock. Patients may also experience allodynia (pain caused by a stimulus that usually does not cause pain) or hyperalgesia (increased pain from a stimulus that normally provokes pain).

The market for neuropathic pain is characterized by a major medical need in all indications and in all major markets, where about 70-80 percent of patients do not get effective pain relief with existing treatment. Due to the risk of abuse, overdose and secondary damage, people now try to avoid opiates as first-line treatment for pain conditions. Despite this treatment problem, these preparations are still used frequently, and therefore the need for new treatments that are not opiates is very great.

The patient population will grow, among other things, due to an aging population and increased number of long-term cancer survivors and increasing prevalance of type-2 diabetes.

The global market for neuropathic pain was valued at $11 billion in 2020 and is expected to grow to $25 billion by 2027.

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