The first quarter of 2023 was very active and eventful for AlzeCure. For example, we completed the clinical part of our Phase II trial with ACD440 for neuropathic pain and we are now processing and analyzing data from the study with the aim of reporting the results in the summer of 2023. In addition, we selected a new complementary molecule as Candidate Drug in our Alzstatin Alzheimer’s project, and we have now initiated preclinical safety testing. We also presented new study data for both Alzstatin and NeuroRestore at the international ADPD Alzheimer’s & Parkinson’s Diseases Conference. It is gratifying to see that we are keeping up the pace as we continue to meet our set goals.
Development in AlzeCure’s pain platform Painless, with the ACD440 and TrkA-NAM projects, is continuing according to plan. During the first quarter, we completed the clinical portion of the Phase II clinical trial with ACD440 for peripheral neuropathic pain, which means that all patients are now included and fully treated. We are now collecting, compiling and processing data with the aim of presenting the results of the study as planned during the summer. ACD440 is a TRPV1 antagonist for topical use aimed at treating peripheral neuropathic pain based on discoveries that garnered the 2021 Nobel Prize in physiology or medicine. The groundbreaking discovery of TRPV1 and its link to pain signaling is of great significance and we have used it in our ACD440 clinical development program. Our second pain project, TrkA-NAM, which focuses on arthritis of the knee, also continues to make good progress. Even though the project is in the early stages, it has drawn the attention of several external parties with whom we have regular contact.
At the end of March, we presented positive new data for ACD856, our leading drug candidate in Alzheimer’s and cognition, at the world-leading Alzheimer’s conference ADPD in Gothenburg. ACD856 is part of our NeuroRestore platform, which includes a new generation of symptom-relieving drug candidates for conditions where learning and memory are impaired, such as Alzheimer’s disease. Recent preclinical data showed that ACD856 could also potentially have a disease-modifying effect. The new preclinical results further support the potential neuroprotective, long term plasticity effect of NeuroRestore, which is extremely promising for continued development within the platform. Taken together, this could indicate that these compounds also have a disease- modifying effect, i.e. they can slow down the progression of the disease. In previously completed Phase I clinical trials (SAD and MAD) of ACD856, the compound showed good safety and tolera bility, and was also shown to stimulate neuronal pathways in the brain relevant for treatment of cognition and depression.
At the ADPD Congress, we also presented new positive data in our Alzstatin platform, which aims to develop a preventive and disease-modifying treatment in tablet form for Alzheimer’s disease. Among other things, Alzstatin reduces the production of the harmful amyloid-beta-42 protein that generates plaques in the brain. The data published at the ADPD congress were produced in collaboration with Professor Henrik Zetterberg and colleagues and relates to ACD860. Alzstatin is a gamma-secretase modulator (GSM), a potentially new class of Alzheimer’s drugs that is receiving growing attention, and there was strong interest at the ADPD meeting. ACD680 is our new supplementary Candidate Drug that offers patent advantages, which has been in the preclinical development phase since January this year. Data showed that ACD680 can reduce harmful amyloid-beta-42 production by over 50 percent, which is significant. In addition to being a preventive treatment against developing Alzheimer’s, Alzstatin could also be used as an adjunct or maintenance treatment to reduce the need for long-term antibody treatment.
It is particularly gratifying that we could present new data from the NeuroRestore and Alzstatin projects at a time when we see strongly growing interest in Alzheimer’s. We have also noted positive new high-profile results from amyloid antibody therapies in 2022, as well as lecanemab receiving accelerated approval from the FDA in the first quarter of 2023. The results for this type of antibody drug are extremely important for the entire Alzheimer’s field and validate the “amyloid hypothesis,” on which AlzeCure’s Alzstatin research platform is also based. The results for lecanemab are promising, but the size of the treatment effect indicates that there will be a need for additional alternative and complementary therapies, such as Alzstatin and NeuroRestore.
We continue to have a strong focus on marketing communications and actively participate in various meetings and congresses presenting AlzeCure and our research to investors and potential partners. In addition to ADPD 2023, we also participated in the JP Morgan days event in San Francisco in January and the BioEurope Spring partnering congress in Switzerland in March. We are encountering growing interest from both private and institutional investors, as well as from pharmaceutical companies and other stakeholders that may be interested in investing in or in-licensing our development projects, or alternatively in entering into a partnership.
With a successful 2022 behind us during which we reached the significant milestone of becoming a Phase II company, an active and productive first quarter of 2023, along with growing interest in both our research and the Alzheimer’s field as a whole, I look forward to continuing to develop AlzeCure together with our talented and ambitious employees and partners.
Stockholm, May 2023