The second quarter of 2024 was once again an active and positive period for AlzeCure Pharma, during which we applied for a patent based on new data concerning the anti-inflammatory effects of our clinical drug candidate ACD856, which is part of our NeuroRestore Alzheimer’s project. We also had new preclinical data from our TrkA-NAM project accepted for presentation at the world-leading IASP pain conference. Furthermore, we published new clinical data from the Phase Ib study for our TRPV1 antagonist ACD440, which we are developing for the treatment of neuropathic pain. We also conducted a rights issue, which raised SEK 39.2 million and was supported by our leading principal owners, with the aim of both funding the continued development of our drug candidates and strengthening the company’s financial position.
The Annual General Meeting elected Dr. Jan Lundberg to serve on the Board of Directors. He has previously served as the global head of research and development at Eli Lilly, as well as global head of research at AstraZeneca. Dr. Lundberg was also a guarantor and invested in the issue without requiring financial compensation, in line with the company’s principal owners.
It is both motivating and gratifying that the company is keeping up the pace as it continues to deliver new data that strengthen our position, supported financially both by the company’s principal owners and its current shareholders, and that we have also added many new shareholders.
In the second quarter, we presented new preclinical data on the anti-inflammatory properties for our clinical NeuroRestore candidate, ACD856, based on which we have applied for a patent. NeuroRestore ACD856, which is being developed in the field of Alzheimer’s disease, has previously shown positive Phase I results, and is now being prepared for further development in a Phase II clinical trial. Preclinical data have shown that the compound can improve learning and memory skills, while also demonstrating disease-modifying and neuroprotective effects, which is of interest in Alzheimer’s and other neurodegenerative diseases.
NeuroRestore is a “Trk-PAM” that enhances NGF and BDNF signaling. NGF and BDNF are neurotrophins that are central to cognition and brain health. Parts of these findings are validated by the results from the Japanese pharmaceutical company Eisai’s clinical drug candidate E2511, which is a TrkA-PAM. What distinguishes ACD856 from E2511 is that in preclinical studies, our drug candidate also demonstrates pro-cognitive properties, which means that it can improve learning and memory skills. This clear differentiation is thought to result from ACD856 also boosting BDNF signaling. There is also strong scientific support for this target mechanism in the treatment of depression. We are now preparing for phase II studies, while also engaging in discussions with external parties regarding potential partnerships or out-licensing.
Alzstatin, our disease-modifying and preventive treatment for Alzheimer’s disease in tablet form, continues to be developed according to plan. Our new drug candidate, ACD680, is in the preclinical development phase and is undergoing safety testing as well as preparations for clinical development. The compound is a complement to ACD679 in the program and offers patent advantages. The Alzstatin projects that belong to the gamma-secretase modulator (GSM) family reduce production of the harmful amyloid-beta-42 protein that generates plaques in the brain, which is considered to be a root cause of Alzheimer’s.
This new class of Alzheimer’s drugs is now receiving increasing attention as the target mechanism was recently validated by the Swiss pharmaceutical company Roche, which is also developing GSMs. The company presented positive clinical Phase I data for its GSM, RG6289, and is now preparing a Phase II clinical trial, which has resulted in growing interest in our Alzstatin project from both other pharmaceutical companies and investors. Alzstatin differs from the antibody drugs in several important respects. One is that Alzstatin is being developed to prevent Alzheimer’s and another is that the treatment is based on small molecules, which means that treatment costs can be kept low and administration is easier.
Moreover, Alzstatin is not expected to cause the side effects associated with existing antibody therapies, such as microbleedings and cerebral edema.
Medical need remains high in the field of Alzheimer’s. Studies show that only five to eight percent1) of Alzheimer’s patients attending memory clinics are suitable candidates for antibody therapy. This shows the potential for the Alzheimer’s projects that we are developing. NeuroRestore is being developed primarily to improve learning and memory in patients, making NeuroRestore an attractive complement or alternative to antibody therapy which could thereby fill a major unmet medical need.
In the Painless platform, which includes the ACD440 and TrkANAM projects, we continue to make good progress. In the second quarter, we published additional data for our TRPV1 antagonist ACD4402), which we are primarily developing for peripheral neuropathic pain (nerve injury pain) and for which we have reported positive clinical results in chronic pain patients3). The results with ACD440, which were published in June in the European Journal of Pain, was from a Phase Ib clinical trial on nociceptive pain (tissue pain), which we were able to significantly reduce by around 50%. The results from our Phase I and II studies have shown that ACD440, a gel that is applied to the skin, demonstrates good suitability
for further clinical development.
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 five patients is satisfied with their current treatment, which demonstrates the great unmet medical need.
of the knee, also continues to make good progress, and we have conducted additional preclinical studies with favorable results during the year. 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 increased obesity-related problems. In the first half of the year, we selected a candidate drug for the project, ACD137, which we will now advance to safety and toxicology studies.
TrkA-NAM is being developed to reduce peripheral NGF signaling and thus pain; because of the selective targeting mechanism of the molecules, TrkA-NAM is not expected to have the side effects that NGF antibodies have demonstrated. We have already demonstrated in several preclinical models that TrkA-NAM has a potent pain-relieving, but also anti-inflammatory, effect, which potentially also broadens the range of applications of the molecules. During the period, new ACD137 data were adopted for presentation at the IASP World Congress on Pain, which is being held in Amsterdam in early August this year. The results we presented show good efficacy in both neuropathic and nociceptive pain, demonstrating the broad potential of the project.
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 June, we participated in BIO International Convention, the world’s largest business development and partnership conference in the pharmaceutical industry, which was held in San Diego, USA, this year. 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.
In the second quarter we carried out a successful rights issue that raised just over SEK 39 million before issue expenses for AlzeCure and that was guaranteed largely through subscription commitments and guarantee commitments from existing owners and members of the company’s management and Board of Directors, among others. Moreover, the company did not have to use the bottom guarantee that had been issued.
As a result of the issue, AlzeCure also gained several new shareholders, including Dr. Jan Lundberg, who was also elected to serve as a board member. We are very pleased and grateful that he has shown strong interest and support and chosen to invest in the company. Dr. Lundberg has more than 25 years of experience in senior positions in the global pharmaceutical companies AstraZeneca and Eli Lilly, including as global head of research and development. Dr. Lundberg has also been a professor at Karolinska Institutet and has published over 500 scientific articles. He also advises international investment funds, including Rhenman and Partners.
The new capital will enable us to develop the business and advance our projects. We will continue to focus on development of the two candidates in the Alzstatin platform to identify a final potential clinical candidate, while also advancing the TrkA-NAM program through the preclinical development phase toward clinical trials. Furthermore, in the coming period, we will develop plans for Phase II clinical trials for ACD856 in Alzheimer’s and ACD440 for the treatment of neuropathic pain. At the same time, we remain strongly focused on business development, with the aim of securing out-licensing of one of our projects.
In the second quarter of 2024, the company’s positive and eventful development continued, with significant progress in all Alzheimer’s and pain projects. We are now entering an exciting new phase in AlzeCure’s development, where the strong support of our major shareholders is very encouraging, which, combined with the company’s achievements and capabilities, bodes well for the future.
Stockholm, August 2024
Martin Jönsson