AlzeCure Pharma AB

STOCKHOLM, SWEDEN / ACCESSWIRE / June 13, 2024 / AlzeCure Pharma (STO:ALZCUR)(FRA:AC6) 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 a scientific article has been published on the clinical phase Ib results that support the continued development of the lead drug candidate Painless ACD440. The article, titled Topically applied novel TRPV1 receptor antagonist, ACD440 Gel, reduces evoked pain in healthy volunteers, a randomized, double-blind, placebo-controlled, crossover study , has been published online in the European Journal of Pain and is written by Märta Segerdahl, MD, PhD and CMO at AlzeCure Pharma. Co-authors are Magnus Halldin, Matthias Rother, Traian Popescu and Klaus Schaffler. The article focuses on the clinical phase Ib study with ACD440. The results show that ACD440 had significant analgesic effects of laser-induced pain compared to placebo both when the individual was asked to rate their pain experience and when pain-related brain activity was measured. Furthermore, significant effects on mechanical pain sensitivity were also observed. The results also showed that the analgesic effects lasted for at least 9 hours and that the product was very well tolerated as a topical gel on the skin, which indicates good suitability for further clinical development, i.e. as a local treatment against nociceptive and neuropathic pain conditions. 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 a strategic in-licensing, originated in Big Pharma and is based on a strong scientific foundation, which in 2021 was awarded a Nobel Prize. The substance is developed as a gel for topical use, which keeps the systemic exposure very low while the concentration of the substance locally can be kept high to achieve a maximum analgesic effect, and over a long period of time. "The publication shows the proof-of mechanism for ACD440, i.e. that the substance has a high and significant pain-relieving effect. Combined with our Phase IIa clinical data in chronic patients with peripheral neuropathic pain, this strengthens the continued development opportunities for ACD440," said Märta Segerdahl, CMO at AlzeCure Pharma. "There is a great medical need for effective and safe non-opioid treatments for neuropathic pain. 7-8 out of 10 patients do not experience a satisfactory effect of existing treatment, and the area is the single largest in pain. Our project ACD440 has a very big potential," said Martin Jönsson, CEO of AlzeCure Pharma. The article is now available online via the following link: 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 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 . 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. Image Attachments CEO Martin Jönsson CMO Märta Segerdahl 2023 Attachments New scientific article published on positive clinical results with Painless ACD440 against neuropathic pain SOURCE: AlzeCure Pharma View the original press release on accesswire.com

STOCKHOLM, SWEDEN / ACCESSWIRE / May 14, 2024 / AlzeCure Pharma (STO:ALZCUR)(FRA:AC6) Today, 14 May 2024, the annual general meeting was held in AlzeCure Pharma AB (publ) (the "Company"). Below is a summary of the resolutions made. All resolutions were passed with the required majority. Resolution regarding the adoption of the accounts and allocation of the Company's result The annual general meeting resolved to adopt the profit and loss statement and the balance sheet. The annual general meeting also resolved to allocate the Company's result in accordance with the board of directors' and the CEO's proposal, meaning that no dividend is paid to the shareholders, and that available funds are carried forward. Discharge from liability for the members of the board of directors and the managing director The annual general meeting resolved to grant discharge from liability to the members of the board of directors and the managing director for the financial year 2023. Election of and remuneration to the board of directors and the auditor The annual general meeting resolved, in accordance with the nomination committees' proposal, on re-election of Thomas Pollare, Ragnar Linder, Janet Hoogstraate och Eva Lilienberg, and to elect Jan Lundberg as a new ordinary members of the board of directors. Thomas Pollare was re-elected as chairman of the board of directors. Jan Lundberg has more than 25 years of experience in senior positions in global pharmaceutical companies, including as Global Head of Research at Astra and then AstraZeneca (1996-2009) and Global Head of Research and Development at Eli Lilly (2010-2018). He has led the development of more than 200 pharmaceutical candidates, with 30 approved products in several therapeutic areas, including Alzheimer's and pain. Jan Lundberg holds a PhD in pharmacology from Karolinska Institutet, and has taught as a professor. His research has resulted in over 500 published articles in peer-reviewed scientific journals and he is an honorary doctor at the Faculty of Pharmacology at Uppsala University and has received both the Fernström and Jahre Prize. Over the years he has also been active in several international regulatory committees. Currently, Mr Lundberg is a board member of four different pharmaceutical and biotechnology companies. The annual general meeting further resolved that the remuneration to the board of directors shall be SEK 250,000 to the chairman and SEK 125,000 to each of the other board members who are not employed by the Company. The annual general meeting also resolved to, in accordance with the nomination committees´ proposal, re-elect Grant Thornton AB as auditor and that the auditor shall be paid according to approved invoice. Grant Thornton AB has announced that the certified accountant Camilla Nilsson will be the auditor in charge. Resolution on the approval of the remuneration report The annual general meeting resolved to approve the board of director's remuneration report in accordance with Chapter 8, Section 53 a of the Swedish Companies Act. Resolution to amend the Articles of Association The annual general meeting resolved, in accordance with the Board's proposal, to amend the Articles of Association. The amendment inserts a new § 10, which enables the Board of Directors to decide that the General Meeting shall be held digitally. Resolution on guidelines for remuneration of persons discharging managerial responsibility The annual general meeting resolved, in accordance with the board of directors' proposal, to adopt the guidelines for persons discharging managerial responsibility to apply until the annual general meeting of 2028 at the latest. In summary, the guidelines concern the terms of employment for the CEO and other senior executives. The guidelines shall apply to remuneration agreed after the adoption of the guidelines by the 2024 annual general meeting. The guidelines do not cover remuneration decided by the AGM. The following are the main elements of the Guidelines: The guidelines shall promote the Company's business strategy and long-term interests and sustainability and provide the Company with the conditions to recruit and retain qualified employees. Remuneration to persons discharging managerial responsibility consist of a fixed, and for certain senior executives, variable salary, other benefits and pension. The base salary shall be proportionate to the executive's skills, responsibilities, authority and performance. A review of the fixed salary shall be conducted on an annual basis for each calendar year. The variable remuneration shall not exceed an amount equivalent to six months' salary for each executive. The annual variable remuneration is based on performance in relation to individually defined qualitative and quantitative measures and performance of the Company in relation to targets set by the Board of Directors. The performance criteria set shall be established and documented annually. Other benefits for the Company consist of customary benefits according to local practice. Such other benefits may include, for example, medical insurance. The pension terms for persons discharging managerial responsibility shall be in line with the market in relation to what generally applies to corresponding executives in the market. The pension shall be based on defined contribution pension solutions or be covered by the general pension plan, either through the ITP plan or through individual occupational pension insurance within the framework of the ITP. Pensionable salary consists solely of basic salary. No severance benefits are paid. Apart from what follows from employment contracts as described above, the senior executives are not entitled to any benefits after termination of employment/assignment. The Board of Directors may decide to temporarily deviate from the guidelines, in whole or in part, if there are special reasons for this in an individual case and a deviation is necessary to meet the Company's long-term interests, including its sustainability, or to ensure the Company's financial viability. Special reasons may also include, for example, that a deviation is deemed necessary in order to recruit or retain key personnel or in extraordinary circumstances such as the Company achieving a certain desired result in a shorter time than planned. Authorisation for the board of directors to resolve on new issues The annual general meeting resolved, in accordance with the board of directors' proposal, to authorise the board of directors, on one or more occasions during the period until the next annual general meeting, with or without deviation from the shareholders' pre-emptive right, to resolve on new issues of shares, warrants and/or convertibles that means issuing, subscribing to or converting a number of shares corresponding to a maximum dilution of 20 per cent of the total number of shares in the Company at the time of the resolution. The new issues can be carried out with or without a provision regarding contribution in kind, set-off or other provisions referred to in Chapter 13, Section 5, first paragraph 6, Chapter 14, Section 5, first paragraph 6 and Chapter 15, Section 5, first paragraph 4, of the Swedish Companies Act. The purpose of the authorisation is to increase the Company's financial flexibility and the board of directors' scope of action. The board of directors, or any other person that they appoint, shall be authorized to make such minor adjustments and clarifications to the resolution that may be required in relation to the registration of the resolution by the Swedish Companies Registration Office. The board of directors' and nomination committee's complete proposals and other documentation in connection with the annual general meeting are available on the Company's website where the minutes from the annual general meeting will also be posted. 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 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, as well as for depression treatment. 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, alternatively partnership, with other pharmaceutical companies. FNCA Sweden AB is the company's Certified Adviser. For more information, please visit . Attachments Communiqué from the annual general meeting of AlzeCure Pharma on 14 May 2024 SOURCE: AlzeCure Pharma View the original press release on accesswire.com

STOCKHOLM, SWEDEN / ACCESSWIRE / May 13, 2024 / AlzeCure Pharma (STO:ALZCUR)(FRA:AC6) 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 has received preclinical data for NeuroRestore in inflammation, with relevance to Alzheimer's disease, and submitted a new patent application for NeuroRestore ACD856, which is now being prepared for phase II clinical studies. "Alzheimer's disease as well as other neurodegenerative diseases are characterized by an inflammatory process in the brain. Prolonged inflammation, with the release of inflammatory and toxic substances, can cause damage and nerve cell death. That we can target these inflammatory processes is something that further opens up new possibilities for ACD856," said Pontus Forsell, Head of Discovery and Research at AlzeCure. New preclinical data show that the NeuroRestore substance ACD856 exhibits anti-inflammatory properties both centrally in the brain and peripherally in the body with relief of clinical inflammatory symptoms in preclinical models and a reduction in several inflammatory markers. These new data indicate an opportunity to treat diseases with elements of neuroinflammation, such as Alzheimer's disease, and that ACD856 can have a disease-modifying effect via its anti-inflammatory properties. ACD856 and the other substances in the NeuroRestore platform stimulate several important signaling systems and signaling substances in the brain such as BDNF (Brain Derived Neurotrophic Factor) and NGF (Nerve Growth Factor), which can lead to improved cognition. Previous preclinical studies have shown that AlzeCure's drug candidates strengthen communication between nerve cells and improve cognitive ability, including learning and memory functions. New preclinical results also show potential neuroprotective and disease-modifying effects with these substances. The biological mechanism behind NeuroRestore enables several indications, such as Alzheimer's and Parkinson's disease, but also depression. "We continue to strengthen the patent portfolio for our NeuroRestore program, and already have approved patents in all major markets such as the USA, Europe, Japan and China. The new results for our clinical drug candidate ACD856, which we are preparing for phase II against Alzheimer's, provide further evidence for a disease-modifying effect as well as general use against neurodegenerative diseases, where neuroinflammation is central. This further improves our commercial opportunities for this promising substance," said Martin Jönsson, CEO. 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 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, as well as for depression treatment. 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, alternatively partnership, with other pharmaceutical companies. FNCA Sweden AB is the company's Certified Adviser. For more information, please visit . About NeuroRestore NeuroRestore is a platform of symptom-relieving drug candidates for disease states in which cognitive ability is impaired, e.g. Alzheimer's Disease, sleep apnea, traumatic brain injury and Parkinson's disease. NeuroRestore stimulates several important signaling pathways in the brain, which among other things leads to improved cognition. Preclinical studies with NeuroRestore have shown that AlzeCure's drug candidates enhance communication between the nerve cells and improve cognitive ability. The NeuroRestore substances are so called Trk-PAMs which stimulate specific signaling pathways in the central nervous system known as neurotrophins, the most well-known being NGF (Nerve Growth Factor) and BDNF (Brain Derived Neurotrophic Factor). The levels of NGF and BDNF are disturbed in several disease states and the signaling is reduced. The impaired function impairs communication between the synapses, i.e. the contact surfaces of the nerve endings, as well as reducing the possibility of survival for the nerve cells, which gives rise to the cognitive impairments. Neurotrophins play a crucial role for the function of nerve cells, and a disturbed function of BDNF has a strong genetic link to impaired cognitive ability in several different diseases, such as Alzheimer's, Parkinson's disease, traumatic brain injury and sleep disorders. There is also a link between BDNF signaling and depression, something that has been further strengthened in recent years. In addition to cognitive-enhancing effects, new preclinical data also show that NeuroRestore substances have a positive effect on mitochondrial function and cell survival, which could indicate potential disease-modifying effects. The leading drug candidate in the platform, ACD856, has recently completed clinical phase I studies and demonstrated positive effects there that support continued development of the program. About Alzheimer's disease Alzheimer's disease is the most common form of dementia, affecting approximately 55 million people worldwide. Alzheimer's disease is a lethal disorder that also has a large impact on both relatives and the society. Today, preventive and disease modifying treatments are missing. The main risk factors to develop Alzheimer's are age and genetic causes. Even though the disease can start as early as between 40 and 65 years of age, it is most common after 65 years. Significant investments in Alzheimer research are being made because of the significant unmet medical need and the large cost of this disease for healthcare and society. The total global costs for dementia related diseases are estimated to about 1,300 billion USD globally in 2019. Given the lack of both effective symptomatic treatments and disease modifying treatments, the need for new effective therapies is acute. The few approved drugs on the market today have only a limited symptomatic effect and can produce dose limiting side effects. A disease modifying treatment for Alzheimer's disease is estimated to reach more than $15 billion in annual sales. In Sweden, approximately 100,000 people suffer from Alzheimer's disease with a healthcare cost of about SEK 63 billion yearly, which is more than for cancer and cardiovascular diseases combined. Image Attachments Martin Jönsson CEO And Pontus Forsell Head Of D&R AlzeCure Pharma Attachments AlzeCure reports anti-inflammatory effects with NeuroRestore ACD856 with relevance to Alzheimer's leading to new patent application SOURCE: AlzeCure Pharma View the original press release on accesswire.com