AlzeCure moving towards Phase IIa clinical trial with ACD440 based on FDA guided response


AlzeCure Pharma AB (publ) (FN STO: ALZCUR), a pharmaceutical company developing a broad portfolio of small molecule drug candidates for diseases affecting the central nervous system, with projects in both Alzheimer’s disease and pain, today announced that it has received a response from the U.S. Food and Drug Administration (FDA) regarding the preIND application that was submitted ahead of the planned Phase IIa study with ACD440 in neuropathic pain.

ACD440, which is the Company’s lead drug candidate in the Painless platform, completed a positive Phase Ib study in 2021 and the Company now plans to initiate a Phase IIa clinical study in patients with peripheral neuropathic pain. Prior to this stage of clinical development, a preIND application was submitted to the FDA. AlzeCure has now received indicative responses that support ACD440’s ongoing development program, as well as preparatory work for the upcoming Phase IIa clinical study.

ACD440 is a TRPV1 antagonist for the topical treatment of patients with neuropathic pain. The discovery of TRPV1, which is the basis of the project, was awarded the Nobel Prize in Physiology or Medicine in 2021.

“With the responses from the FDA, we can now proceed as planned with the next clinical phase, a planned Phase IIa study in patients. The responses we received from the FDA gave us good direction for the project. Our project team for ACD440 for neuropathic pain has done a great job,” said Martin Jönsson, CEO of AlzeCure Pharma.

“The medical need for neuropathic pain is enormous. Over 60% of patients in the United States have been prescribed opioids, which can be very problematic. With our project, we want to develop an effective and safer alternative. great, our ambition is to be able to obtain a Fast Track designation from the FDA in order to make our potential drug more quickly available to patients. »

For more information please contact

Martin Jonsson, CEO
Tel: +46 707 86 94 43
[email protected]

About AlzeCure Pharma AB (publ)

AlzeCure® is a Swedish pharmaceutical company that develops innovative new drug therapies for the treatment of serious diseases and conditions that affect the central nervous system, such as Alzheimer’s disease and pain – indications for which currently available treatments are very limited. The company is listed on the Nasdaq First North Premier Growth Market and is developing multiple parallel drug candidates based on three research platforms: NeuroRestore®, Alzstatin® and Painless.

NeuroRestore consists of two symptomatic drug candidates whose unique mechanism of action enables multiple indications, including Alzheimer’s disease, as well as cognitive disorders associated with traumatic brain injury, sleep apnea and Parkinsons. The Alzstatin platform focuses on the development of disease-modifying and preventive drug candidates for the early treatment of Alzheimer’s disease and includes two drug candidates. Painless is the company’s pain research platform and contains two projects: ACD440, which is a drug candidate in clinical development for the treatment of neuropathic pain, and TrkA-NAM, which targets pain intense in conditions such as osteoarthritis. AlzeCure aims to pursue its own projects through pre-clinical research and development to an early clinical phase, and continuously works on commercial development to find suitable licensing solutions with other pharmaceutical companies.

FNCA Sweden AB, +46(0)8 528 00 399 [email protected], is the company’s certified advisor. For more information, please visit

About Neuropathic Pain
Neuropathic pain affects approximately 7-8% of the total adult population, which corresponds to approximately 600 million people worldwide. Some patients, with indications such as diabetes and HIV, are more affected, where approximately 25 and 35% of patients, respectively, experience neuropathic pain.

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

The neuropathic pain market is characterized by a major medical need across all indications and in all major markets, where approximately 70-80% of patients do not experience effective pain relief with existing treatments.

The patient population will increase, among other things, due to the aging of the population, the increase in the number of long-term cancer survivors and the increasing prevalence of type 2 diabetes.

Global Neuropathic Pain Market was valued at USD 11 Billion in 2020 and is projected to reach USD 25 Billion by 2027.

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Martin Jönsson CEO and Johan Sandin CSO AlzeCure Pharma


AlzeCure moving towards Phase IIa clinical trial with ACD440 based on FDA lead response

THE SOURCE: AlzéCure Pharma

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