A word from the CEO

During the third quarter, we received positive data from our Phase I SAD clinical trial with the drug candidate ACD856, which is part of the NeuroRestore platform and which we are developing with a focus on Alzheimer’s disease. We also received approval to test higher doses of the compound in the study, which is now underway, and after the end of the quarter we also started our Phase I MAD clinical trial with this compound. Regarding our ACD440 pain project, that belongs to the Painless platform and targets neuropathic pain, we have now submitted a request for a pre-IND meeting to the FDA for a planned Phase II study. We also focused on further developing new compounds in our preclinical pain project, TrkA-NAM, with the aim of choosing a drug candidate for the project in the second half of 2021. Thus we have once again closed the books on yet another positive and very active quarter at AlzeCure.

During another active quarter, AlzeCure received positive data as planned from the Phase I SAD clinical trial with ACD856, which is being developed with a focus on Alzheimer’s disease, and has now also initiated the Phase I MAD clinical trial with this compound.

Martin Jönsson, CEO

AlzeCure continues to make good progress, according to plan, in areas that are increasingly relevant and drawing greater attention. Interest in Alzheimer’s disease is growing, which was particularly evidenced by the US Food and Drug Administration’s (FDA) approval over the summer of a new drug for the disease, AduhelmTM (aducanumab), the first new drug for Alzheimer’s disease in 18 years. Subsequently, the FDA granted “Breakthrough Therapy Designation” to three additional antibody drugs for Alzheimer’s disease.

Through its actions and announcements, the FDA has demonstrated its understanding of the great medical need in this area and its support for the amyloid hypothesis: that the build-up of harmful amyloid beta in the brain plays a fundamental role in the development of Alzheimer’s disease.

The FDA decisions and the increased activity in the field of Alzheimer’s are highly encouraging, both for patients and for AlzeCure with respect to interest from Big Pharma in our Alzheimer’s projects. We see great benefits from our projects, which are based on small molecules that do not require invasive administration in the inpatient setting, but can be taken as a tablet at home. Small molecules can also be more easily designed to better penetrate the blood-brain barrier and they are often more cost-effective than biologics, which is important for chronic treatment. With the dementia and Alzheimer’s patient population – currently 50 million patients worldwide – expected to triple within the next 30 years, there will be high demand for preventive therapies that avert damage to brain structures and that are not resource-intensive.

Our Alzstatin project platform aims to develop preventive disease-modifying treatments for Alzheimer’s by reducing production of harmful amyloid-beta and thereby preventing accumulation of pathological amyloid in the brain. In the Alzstatin program we have preclinical studies that have shown that we can reduce the quantity of harmful amyloid-beta by 50 percent. ACD679 is currently in the preclinical development phase, while research continues in the ACD680 follow-up project to ensure that we can choose the best possible compound for future clinical trials.

ACD856 is part of the innovative NeuroRestore platform with a primary focus on symptomatic treatment of Alzheimer’s – in other words, improving the memory and other cognitive problems that are so typical of the disease. The ongoing SAD clinical trial with ACD856 is evaluating tolerability and safety. During the third quarter, we received positive data in the study and applied for the testing of even higher doses, which was granted by the Swedish Medical Products Agency. These studies have now been initiated, as has the MAD clinical trial (Phase I), in line with our communicated objectives. Our other drug candidate in the NeuroRestore platform, ACD857, is in the preclinical development phase. We plan to use this compound for an indication within the field of cognitive dysfunction, which includes Alzheimer’s.

We also see continued promising progress in our pain platform Painless, which consists of two projects, ACD440 and TrkA-NAM. ACD440 is a TRPV1 antagonist for topical use aimed at treating neuropathic pain. The project is based on discoveries for which the 2021 Nobel Prize in Physiology or Medicine was awarded this year. We have used the groundbreaking discovery of TRPV1 and its link to pain perception in our ACD440 clinical program. Based on the positive results from the Phase Ib clinical trial of ACD440, which were obtained earlier than expected last spring, we were able to report positive and significant safety and tolerability results, as well as early signals of efficacy on pain. The neuropathic pain indication currently generates global pharmaceutical sales of USD 10.8 billion each year and is expected to grow significantly to over USD 25 billion by 2027 (GlobalData, 2021). Data suggests that more than half of patients with neuropathic pain today do not achieve adequate pain relief. This indicates the great unmet medical need, as well as the potential in this field and for our ACD440 project. We hope to be able to apply to initiate a Phase II clinical trial by the end of this year. The patients we intend to treat suffer from chronic pain, a patient population that is expected to continue to grow, in part due to the aging population.

TrkA-NAM, our second pain project within the Painless platform, is aimed at treating severe pain conditions. One such example is osteoarthritis, which is estimated to affect over 300 million people. After having received positive efficacy data from our preclinical pain studies, we are now actively working to select a final drug candidate for the project, with the goal of doing so in the fourth quarter of 2021.

During the quarter we continued to have a strong focus on marketing communication and participated in several meetings and conferences. Together with Professor Maria Eriksdotter from Karolinska Institutet and others, we arranged a symposium in September focusing on NeuroRestore. The symposium was very well received and is recorded and available on our website. During the quarter, we also published several abstracts and posters at scientific congresses (AAIC and ECNP), as well as a scientific article in the journal Cells on our NeuroRestore project ACD856*, among other topics. These publications demonstrate the interest in and the scientific quality of the data we generate. We continue to work on reaching out to both private and institutional investors, as well as other pharmaceutical and research companies that may be interested in investing in or in-licensing our development projects, or alternatively in entering into a partnership.

I am very pleased to report that AlzeCure continues to make good progress together with our dedicated and motivated employees. We have several promising projects under development within fields with great unmet medical need, which is incredibly motivating. The rising interest and activity in the field of Alzheimer’s is beneficial to us, for which reason we look to the future with continued growing confidence.

Stockholm, November 2021

Martin Jönsson