The patient recruitment milestone has been reached for AlzeCure's Phase II clinical trial in neuropathic pain with non-opioid ACD440

Uppsala Sweden, January, 31, 2023
LINK Medical, the Northern European clinical research organization (CRO), and AlzeCure Pharma AB (publ) (FN STO: ALZCUR), announced today that the last patient has been enrolled in the phase II clinical trial for neuropathic pain treated with the non-opioid ACD440.

Alzecure is a pharmaceutical company that develops a broad portfolio of drug candidates for diseases affecting the central nervous system, with projects in both Alzheimer’s disease and pain. This is a unique trial leading a non-opioid drug candidate in the painless platform which is being developed for peripheral neuropathic pain.

The regulatory authorities approved for the study to start last summer as well as the patient recruitment using a successful decentralized approach. The Phase II clinical trial is a double-blind, placebo-controlled, randomized cross-over study evaluating the efficacy, safety, and pharmacokinetics of AlzeCure's leading drug candidate in pain, ACD440. The main results from the study are expected by the summer of 2023 at the latest.

ACD440 is a TRPV1 antagonist and a first-in-class local treatment for patients with peripheral neuropathic pain. The discovery of TRPV1, which is the basis for the project, was awarded the Nobel Prize in Physiology or Medicine in 2021. ACD440, which is applied as a gel, is the company's leading drug candidate in the Painless platform and Alzecure conducted a positive phase Ib study in 2021.

The medical need for neuropathic pain is very large, not at least to find alternatives to opioids. The market for neuropathic pain is the single largest market segment in pain treatment, with annual sales of over USD 11 billion. Up to 80% of patients do not get a satisfactory effect with their current treatments.

“The study has developed well and the fact that we have now been able to include the last patient in the study means that we have good hopes that the study will also deliver the results according to what we previously communicated,” said Märta Segerdahl, MD, PhD, project leader and CMO at AlzeCure. We see an exciting potential with ACD440, where you can broaden the further development with other formulations, thereby enabling several indications.”

"With the previous positive results from the phase Ib study, we look forward to the readout of this phase II study. There is already interest in the project and with phase II data, the project can generate even greater interest for out-licensing in a segment with a very high medical need," said Martin Jönsson, CEO of AlzeCure Pharma.

“We are very happy to support AlzeCure, providing our experienced team, technology, and infrastructure for an efficient collaboration with the site and patients. This is an important milestone in the clinical development of this promising drug candidate, and we look forward to continuing to support and drive innovative solutions, efficiency, and speed.” – said Sissel Andresen, CEO at LINK Medical

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 as 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 prevalence 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.

About LINK Medical

LINK Medical is a full-service contract research organization (CRO) providing product development services for the pharmaceutical and medical device industries across Northern Europe. LINK Medical offers a well-integrated local presence in all Nordic countries, UK and Germany. Reaching from early phase development to post-marketing and providing expert guidance across every aspect of a project – all from ONE source. LINK Medicals' promise is to improve and accelerate your product development through transformative methods, active communication, and optimal solutions. As a strategic partner, LINK Medical provides expert competence and technology to enable evidence-based decision-making that supports the delivery of superior clinical outcomes.
www.LINKMedical.eu | info@LINKMedical.eu

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 out licensing solutions with other pharmaceutical companies.

FNCA Sweden AB, +46(0)8 528 00 399 info@fnca.se, is the company’s Certified Adviser. For more information, please visit www.alzecurepharma.se.

For more information, please contact

LINK Medical
Sissel Lønning Andresen, CEO
Tel: +47 41641451
Sissel.Andresen@linkmedical.eu

Editorial contact:
Claudia Wennberg, Sr. Marketing and Brand Manager
+46 708244398
Claudia.Wennberg@LINKMedical.eu

AlzeCure Pharma
Martin Jönsson, CEO
Tel: +46 707 86 94 43
Martin.Jonsson@alzecurepharma.com