AlzeCure Pharma Conducts Strategic Inlicensing of Clinical Phase Drug Candidate for Neuropathic Pain

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 exclusively inlicensed a VR1 project, which is in clinical phase and targeting neuropathic pain, from the Swedish company Acturum Life AB.

The VR1 project is in the clinical development phase, and AlzeCure's aim is to develop a new topical local treatment for neuropathic pain. The mechanism of action of the project is via VR1 receptors, which have a key role in pain signaling.

The agreement with Acturum covers all indications for the global market and no milestone payments are due before clinical phase II studies are initiated. Furthermore, the agreement does not include any upfront payments. AlzeCure plans to initiate a clinical proof-of-mechanism study (phase Ib) with the project in the latter part of 2020. Thanks to existing preclinical and clinical documentation, this is estimated to cost only SEK 10-15 million. AlzeCure has, with a good margin, funding for the current proof-of-mechanism study.

AlzeCure sees the VR1 project as an important strategic in-licensing that fits well into the company's existing pipeline and strengthens the clinical portfolio. The VR1 project originates from Big Pharma and is based on a solid scientific foundation. The substance was previously evaluated in phase I clinical trials, where in addition to tolerability, early effect signals were also observed. The team behind AlzeCure has a long industrial experience from the development of new drugs in the central nervous system (CNS) and pain. AlzeCure has also since before a preclinical pain project in its current project portfolio, TrkA-NAM, for the treatment of severe pain conditions.

Neuropathic pain is associated with impaired quality of life, and today's treatment rarely provides adequate pain relief. In total, about 7–8 percent of the adult population worldwide is estimated to be suffering from pain with neuropathic features, which only in the US, Europe and Japan corresponds to about 25 million individuals. About 50 percent of the those do not respond to existing first-line treatment and it is patients in this group that AlzeCure targets their new intended treatment.

 “The fact that many patients with neuropathic pain do not receive effective pain relief from existing drugs, together with the well-known addiction problem of opioid drugs, has led to a significant increase in the need for new innovating pain medications. With this in-licensing, our clinical pain experts see that we may have the opportunity to attack neuropathic pain in a whole new way. In addition, we are also expanding our project portfolio with another project in clinical phase”, said Johan Sandin, CEO of AlzeCure Pharma.

For more information, please contact

Johan Sandin, CEO

Tel: +46 703 738 824

johan.sandin@alzecurepharma.com

This is information that AlzeCure Pharma AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above at 10.00 am CET on January 7, 2020.

About AlzeCure Pharma

AlzeCure Pharma AB is a Swedish pharmaceutical company engaged in innovative drug research with a primary focus on Alzheimer’s disease. The company is listed on Nasdaq First North Premier Growth Market and is developing five drug candidates based on the two research platforms, NeuroRestore and Alzstatin. The NeuroRestore platform comprises symptom-relieving drug candidates while Alzstatin comprises disease modifying and preventive drug candidates. A diversified portfolio of drug candidates that act on central signaling pathways in the brain also opens up for other indications such as cognitive dysfunctions in traumatic brain injury (TBI), sleep apnea and Parkinson’s disease. The company also has a project in the field of pain in early preclinical phase, TrkA-NAM. FNCA Sweden AB is the company’s certified adviser: contact +46(0)8-528 00 399, info@fnca.se. For further information, please visit our website at www.alzecurepharma.se

About neuropathic pain

• Neuropathic pain affects approximately 7–8 percent of the adult population in total. Some patients, with indications such as diabetes and HIV, are affected to a greater extent where approximately 25% and 35% 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, metabolic, infectious or compressional injuries. Common symptoms are painful tingling that can be described as 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 incidence of cancer and 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.