A word from the CEO

The fourth quarter of 2023 continued to be positive and eventful for AlzeCure Pharma. During the period, we presented new preclinical data which show that our clinical drug candidate NeuroRestore ACD856 potentially has neuroprotective and disease-modifying effects in Alzheimer’s and other neurodegenerative diseases. We also received new patents for ACD856 and published new data for NeuroRestore and Alzstatin validating the target mechanisms and stimulating interest in the two Alzheimer’s programs. In addition, we presented phase II clinical results for ACD440 for the treatment of peripheral neuropathic pain. It is both motivating and gratifying that we are keeping up the pace as we continue to deliver new data that strengthen our position. Furthermore, we have now also selected a drug candidate in our TrkA-NAM project, ACD137.

In the Painless platform, which includes the ACD440 and TrkA-NAM projects, we continue to make good progress. During the fourth quarter, we published positive results from the Phase II study with our TRPV1 antagonist ACD440 for the treatment of chronic peripheral neuropathic pain. The study results, which were presented in October at the meeting for Swedish pain specialists in Uppsala, showed a clear and significant effect on pain caused by cold or heat in patients with peripheral neuropathic pain. This temperature hypersensitivity is common in patients with neuropathic pain and is a major problem for these individuals. The results from our phase II clinical trial also showed that ACD440, which is a gel that is applied to the skin, was well tolerated. Taken together, the results with both the drug and administration method demonstrate good suitability for further clinical development. The detailed data obtained from the Phase II clinical trial in the autumn is now being analyzed in greater depth and discussed with experts in the field with regard to the continued clinical development program.

Neuropathic pain is an area with great unmet medical need, especially with respect to finding alternatives to opioids, and we believe that ACD440 could significantly improve quality of life for patients suffering from this type of pain. Only one of eight patients is satisfied with their current treatment, which demonstrates the great unmet medical need. Moreover, we also see opportunities for our compound in nociceptive pain (tissue damage pain), which we generated data on in 2021. Our second pain project, TrkA-NAM, which focuses on arthritis of the knee, also continues to make good progress, and during the period we conducted additional preclinical studies. In January 2024, we selected a drug candidate for the project, ACD137, which will proceed further into safety and toxicology studies. Interest in TrkA-NAM has risen as Asahi Kasei has now initiated a Phase IIb study with his candidate AK-1830. TrkA-NAM is being developed to reduce peripheral NGF signaling, and because of the project’s unique and selective targeting mechanism, TrkA-NAM is not expected to have the side effects of NGF antibodies.

Over 300 million people are estimated to suffer from osteoarthritis of the knee and the patient population is growing due to an aging population and obesity-related problems. During the quarter, we also presented and published new data for our clinical NeuroRestore candidate, ACD856, at the CTAD Alzheimer’s Congress in Boston, USA. NeuroRestore ACD856 is a Trk-PAM and the new preclinical findings revealed potential disease-modifying and neuroprotective effects, which is of interest in Alzheimer’s and other neurodegenerative diseases. These findings are validated by the results from another drug candidate, Eisais TrkA-PAM E2511, which is also in the clinical phase. Eisai published data at the same congress showing that their compound also has potential disease-modifying effects in Alzheimer’s and other neurodegenerative diseases. Our drug candidate ACD856 differentiates from Eisai’s in that it also demonstrates pro-cognitive properties, which means that it could improve learning and memory skills. This marks a clear differentiation as NeuroRestore ACD856 also boosts BDNF signaling. During the quarter, the Japanese Patent Office approved our patent application for NeuroRestore, including ACD856. This is yet another important step for ACD856 and the NeuroRestore platform, which previously gained patent protection in the US and Europe until 2039.

Alzstatin, our disease-modifying and preventive treatment in tablet form for Alzheimer’s disease, continues to be developed according to plan. Our new supplementary candidate drug, Alzstatin ACD680, is in the preclinical development phase and is undergoing safety testing. The compound complements ACD679 and could offer patent advantages. The candidate drugs in Alzstatin are “gammasecretase modulators” (GSMs), which reduce production of the harmful amyloid-beta-42 protein that generates plaques in the brain. The process is considered a primary cause of Alzheimer’s. This new class of drugs for Alzheimer’s is now garnering increasing attention. The target mechanism is being validated by the Swiss pharmaceutical company Roche, which is also developing GSMs. At the CTAD Alzheimer’s conference, Roche presented positive clinical data for its GSM RG6289 and is now preparing a Phase II clinical trial, which also boosts interest in our Alzstatin project from both other pharmaceutical companies and investors.

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 November, we participated in BioEurope, one of the world’s largest business development and partnership conferences, which was held in Munich. We continue to encounter growing interest from institutional investors, 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 four strong quarters in 2023, during which we delivered positive Phase II results, published new data to support our projects and saw continued 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 partners and our employees in 2024.

 

Stockholm, February 2024
Martin Jönsson