The first quarter of 2025 was yet another active and eventful quarter for AlzeCure Pharma.
In February 2025, we received a grant of EUR 2.5 million from the European Innovation Council (EIC), with the possibility of additional funding through the EIC fund. We are very proud and honored to receive this prestigious grant, which is both a significant financial contribution to the company and an acknowledgment of the groundbreaking potential of ACD856.
During the quarter, we also published and presented new positive preclinical findings from our clinical Alzheimer’s project, NeuroRestore ACD856, at the world-leading Alzheimer’s and Parkinson’s Diseases (AD/PD) conference. We also published new data in our other Alzheimer’s project, Alzstatin, which showed a clear plaque-reducing effect, among other findings. With these positive results, we demonstrate that AlzeCure continues to deliver.
The grant from the European Innovation Council (EIC) Accelerator of EUR 2.5 million is of great importance to AlzeCure, both financially and as a validation of our Alzheimer’s project, NeuroRestore ACD856. The grant will accelerate our clinical development and bring us closer to the goal of delivering a transformative therapy for Alzheimer’s patients. We received the grant for the Phase II clinical study of our drug candidate ACD856 in patients with Alzheimer’s disease, which we presented to the EIC. The EIC has also offered potential additional funding through an investment in the company, which we are now exploring.
During the first quarter, we also published and presented additional preclinical data for NeuroRestore ACD856. We have previously shown in preclinical models that ACD856 can improve learning and memory function. The latest findings show that ACD856 also has disease-modifying and anti-inflammatory effects. These new results indicate that with ACD856, we can also target inflammatory processes, which are a key element of disease progression in conditions such as Alzheimer’s disease. The study was presented at the AD/PD (Alzheimer’s Disease/Parkinson’s Disease) conference in April.
During the quarter, NeuroRestore was also highlighted in an article in Nature as a potential obesity treatment. The rationale is that the neurotrophin BDNF, which NeuroRestore modulates, plays a key role in metabolism, insulin sensitivity, and appetite suppression. BDNF signaling also appears to be important for the effect of GLP-1 agonists used for obesity and diabetes treatment, such as Novo Nordisk’s semaglutide (Ozempic® & Wegovy®) and Eli Lilly’s tirzepatide (Monjaro® & Zepbound®). This could imply positive synergy effects between GLP-1 agonists and NeuroRestore compounds.
AlzeCure already has preclinical data showing that one effect of NeuroRestore ACD856 is to improve insulin sensitivity, among other effects. Sales in the obesity and diabetes sector are enormous and rapidly growing, and we will monitor this area with great interest, particularly regarding preclinical and clinical trials.
Alzstatin, our disease-modifying and preventive treatment in tablet form for Alzheimer’s disease, continues to be developed according to plan. The drug candidate in the platform, ACD680, is in preclinical development and is being prepared to enter clinical trials. The results indicate that with ACD680, we potentially have a so-called “Best-in-Class” molecule. Additionally, ACD680 is expected to have a long patent term, until 2045, as well as an additional five years of exclusivity in the US, which is very valuable.
The compounds in Alzstatin are gamma-secretase modulators (GSM), which reduce the production of the harmful protein amyloid-beta-42 that generates plaques in the brain. The biological process is considered a primary cause of Alzheimer’s disease. GSM for Alzheimer’s has received growing attention over the year as the target mechanism has been validated by the Swiss pharmaceutical company Roche, which is also developing GSM compounds, leading to increased interest in our Alzstatin project from other pharmaceutical companies and investors. Furthermore, interest in GSM as a class of drugs is on the rise, as they not only reduce plaque formation but also potentially enhance the brain’s resilience and may even remove existing plaques in the brain.
During the quarter, we published an article on this topic in the journal JPET, co-authored by Professor Henrik Zetterberg at Sahlgrenska and University College London, with whom we collaborate on our Alzheimer’s project. The findings showing that a GSM can reduce the amount of existing plaques are groundbreaking and promising.
In the field of Alzheimer’s, the medical need for effective treatments remains significant. Studies show that only 5–8% of Alzheimer’s patients seen at memory clinics are regarded as appropriate candidates for prescription of the newly developed antibody therapies. This means that 92–95% of diagnosed Alzheimer’s patients are not expected to be treated with the recently approved antibody therapies. As a result, both NeuroRestore and Alzstatin could become highly attractive treatments in their own right, while also serving as a complement to antibody therapies, thereby addressing a high unmet medical need for patients, their families, and the healthcare system.
Our pain projects in the Painless platform, ACD440 and TrkA-NAM, continue to make good progress.
With our TRPV1 antagonist ACD440, which we are primarily developing for topical treatment of peripheral neuropathic pain (nerve injury pain), we have previously obtained positive clinical Phase IIa results in patients with chronic neuropathic pain. We have also conducted a Phase Ib clinical trial in nociceptive pain (tissue damage pain), in which, as in the Phase IIa study, we were also able to reduce the pain by about 50%. The results from these studies have shown that ACD440, which is administered as a gel applied to the skin, demonstrates good suitability for continued clinical development, where we are now preparing for further complementary Phase II studies. Neuropathic pain is an area with great unmet medical need, especially with respect to finding alternatives to opioids. We believe ACD440 could significantly improve quality of life for patients suffering from this type of pain. Only one in five patients is satisfied with their current treatment, highlighting the great unmet medical need and associated societal burden. Our aim is for ACD440 to become a key treatment of choice in this area.
Our second pain project, TrkA-NAM, focuses on arthritis of the knee. Over 300 million people suffer from the disease and the patient population is growing due to an aging population and obesity-related problems. TrkA-NAM is being developed to reduce peripheral NGF signaling and thus pain. Because of the selective target mechanism of the molecules, TrkA-NAM is expected to maintain the good analgesic effects but avoid the side effects that NGF antibodies have previously demonstrated. The project is progressing well, and we have generated positive findings in several different preclinical studies, with a number of different molecules. In 2024, we selected a candidate drug for the project, ACD137, for which we applied for a patent. The patent protection is expected to last until 2045, plus five years of additional exclusivity in the US.
The compound has powerful analgesic effects in several different preclinical models as well as in both neuropathic and nociceptive pain, indicating a wide range of applications for the compound. ACD137 has also been shown to have anti-inflammatory effects, which may further strengthen its pain-relieving properties, as well as potentially opening up other possible indications. Results from a preclinical study with ACD137 in an osteoarthritis model recently showed significant pain relief in both movement-induced and evoked pain, as well as a significant anti-inflammatory effect. The analgesic effect of ACD137 was as potent as that of the anti-NGF antibody Tanezumab, which has demonstrated significant and robust pain relief in patients in several clinical trials. ACD137 was also shown to have a protective effect against articular cartilage damage, showing a significant improvement in several structural parameters of cartilage and the knee joint, suggesting a protective effect on knee joint function in an osteoarthritis model. We are now preparing ACD137 for further preclinical safety studies.
We continue to focus on marketing communications and actively participate in various meetings and congresses to present our research to investors and potential partners. In January, we participated in JP Morgan Week – the world’s leading business development and partnership event for the pharmaceutical industry. We also took part in SwissNordicBio in Zurich and Bio Europe Spring, which was held in Milan in March. We are encountering continued growing interest 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.
Overall, we continued to make progress in our Alzheimer’s and pain projects with new findings and a strengthened patent portfolio. The grant from the EIC for the Phase II study in the Alzheimer’s project NeuroRestore ACD856 reinforces the validation of both the project and the company, with the possibility of additional funding. In collaboration with renowned institutions and scientists, both in Sweden and abroad, we published exciting new results in our projects during the quarter that further strengthen the potential and improve our business development opportunities going forward.
With a strong start to the year, I look forward to working with my colleagues and our partners to ensure continued success in 2025.
Stockholm, May 2025
Martin Jönsson, CEO of AlzeCure Pharma AB