AlzeCure announces positive data from clinical study with ACD440

AlzeCure announces positive data from clinical study with ACD440

AlzeCure Pharma AB (publ) (FN STO: ALZCUR), 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, today announced that the company has received positive results from the phase Ib clinical study with its drug candidate ACD440 for neuropathic pain.

The results, presented slightly ahead of plan, demonstrate that ACD440, a TRPV1 antagonist and AlzeCure’s drug candidate for neuropathic pain within the company's Painless platform, was able to demonstrate positive proof-of-mechanism data, showing analgesic efficacy in man. The observed effects with ACD440 were highly significant over placebo. Also, it was well tolerated as a topical gel on human skin which indicates good suitability for further clinical development, i.e. as a local treatment for neuropathic pain conditions.

“We are very pleased that ACD440 was both well-tolerated and able to show good analgesic efficacy,” said Johan Sandin, CSO at AlzeCure Pharma. “Neuropathic pain is an area with a huge unmet medical need and we believe that ACD440 could significantly improve the quality of life for patients suffering from neuropathic pain.”

“The results from this completed proof-of-mechanism study show that ACD440 has very good characteristics and at the same time demonstrate the value of AlzeCure's broad portfolio of projects, which together with the company's strong cash position, provides a strong value proposition to both investors and pharma companies,” said Martin Jönsson, CEO of AlzeCure. “We are now looking forward to taking ACD440 further into Phase II studies, which may also generate even greater out-licensing interest.”

AlzeCure Pharma initiated the Phase Ib clinical study with ACD440 in December 2020. Preparations are ongoing to initiate further clinical trials and IND filing, with a planned filing for a Phase II trial by the end of 2021.

For more information, please contact

Martin Jönsson, CEO
Tel: +46 707 86 94 43
martin.jonsson@alzecurepharma.com

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 extremely 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 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 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 to early clinical phase, and is continually working on business development to find suitable outlicensing 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.

About Neuropathic pain
Neuropathic pain affects approximately 7–8 percent of the total adult population. 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 only about 50 percent of patients respond to existing treatment.

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

The global market for neuropathic pain was valued at $5 billion in 2015 and is expected to grow to $8 billion by 2024.

This information is information that AlzeCure Pharma is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 2021-04-19 16:00 CEST.