The first quarter of 2024 was positive and active for AlzeCure Pharma. In our clinical Alzheimer’s program, NeuroRestore
ACD856, we presented new preclinical data supporting neuroprotective and disease-modifying effects at the major international Alzheimer’s conference AD/PD 2024.
In addition, we had patents for NeuroRestore and ACD856 approved in China and several other countries, which strengthens our business development opportunities. During the quarter, we also selected a drug candidate in our pain project for treatment of knee osteoarthritis, TrkA-NAM.
Our research and development was also further recognized by a government and ministerial visit, as well as by an investment by Eli Lilly’s former global head of research and development, Dr. Jan Lundberg, who was also global head of research for AstraZeneca.
He has also made himself available for a position on the company’s Board of Directors, which is supported by the nomination committee. To finance the further development of the above-mentioned drug candidates, and to strengthen the company’s financial position, the Board of Directors proposed during the quarter a rights issue of approximately SEK 52.8 million. 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, and that we are receiving increasing recognition from external parties.
During the quarter, we presented and published new data for our clinical NeuroRestore candidate, ACD856, at the AD/PD 2024 Alzheimer’s conference in Lisbon, Portugal. NeuroRestore ACD856
is a “Trk-PAM” and the new preclinical findings revealed potential disease-modifying and neuroprotective effects, which may be of interest in Alzheimer’s and other neurodegenerative diseases.
Parts of these findings are validated by the results from another drug candidate, Eisais TrkA-PAM E2511, which is also in the clinical development phase. What distinguishes ACD856 from Eisai’s
TrkA-PAM E2511 is that ACD856 also demonstrates pro-cognitive properties, which means that it can improve learning and memory capabilities. This marks a clear differentiation and is due to the
fact that NeuroRestore ACD856 also boosts BDNF signaling. There is also strong scientific support for this target mechanism within the treatment of depression. We are now preparing for phase II studies, while also engaging in discussions with external parties regarding partnerships and out-licensing.
The company’s patent applications for NeuroRestore, including ACD856, were approved in six additional countries, including China. This is yet another important step for ACD856 and the
NeuroRestore platform, which was previously granted patent protection in the US, Japan and Europe until 2039. In connection with market approval, we also expect that we can obtain an additional five years of exclusivity, including in the US, so that NeuroRestore ACD856 is protected until 2044.
Alzstatin, our disease-modifying and preventive treatment in tablet form for Alzheimer’s disease, continues to be developed according to plan. Our new drug candidate, ACD680, is in the preclinical development phase and is undergoing safety testing, with preparations to enter the clinical development phase in 2025. The compound is a complement to ACD679 in the program and offers patent advantages. The candidate drugs in Alzstatin are “gamma-secretase 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 Alzheimer’s drugs is now receiving increasing attention as the target mechanism has been 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 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 it is a small molecule. The latter means that 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 percent*) of Alzheimer’s patients attending memory clinics are suitable candidates for being prescribed the antibody drugs.
This shows the potential for the Alzheimer’s projects that AlzeCure is developing. We presented a seminar on this topic, highlighting Alzstatin and gamma secratase modulators as an attractive treatment option, together with Professor Henrik Zetterberg, a world leader in the field who is active at institutions such as the University of Gothenburg and University College of London. He has been a collaboration partner in our Alzstatin project for several years.
The seminar is available on our website and on our YouTube
channel (https://www.youtube.com/watch?v=RMlCxuBrrAw&t=20s)
In the Painless platform, which includes the ACD440 and TrkANAM projects, we continue to make good progress. In the autumn of 2023, 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 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 outcome from both the compound and the administration method demo-nstrate good suitability for further clinical development. Detailed data are 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), for which we also received data in our phase I clinical trial.
Our second pain project, TrkA-NAM, which focuses on arthritis of the knee, also continues to make good progress, and during the year we conducted additional preclinical studies. 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. In the most recent quarter, we selected a candidate drug for the ACD137 project, which we will now advance to safety and toxicology studies. Interest in TrkA-NAM has risen as Asahi Kasei has recently initiated
a Phase IIb study with its candidate drug AK-1830. TrkA-NAM is being developed to reduce peripheral NGF signaling and thus pain.
Because of the project’s unique and selective targeting mechanism, TrkA-NAM is not expected to have the side effects of NGF antibodies. We have already demonstrated in several models that we have a potent pain-relieving, but also anti-inflammatory, effect. At the international and world-leading IASP pain conference, which this year is being held in Amsterdam in July, we will present additional data from the TrkA-NAM project’s drug candidate, ACD137. 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 March, we participated in BioEurope, one of the world’s largest business development and partnership conferences, which was held in Barcelona. We continue to experience 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, and the company is in discussions with several potential players.
The Board of Directors has therefore concluded that it would be advantageous to reinforce the cash position to gain better bargaining power and facilitate the continued advancement of the company’s research portfolio to boost the value and attractiveness of the assets. Consequently, on March 26, 2024, the Board of Directors resolved on a new issue of shares of approximately SEK 52.8 million with preferential rights for existing shareholders. The Rights Issue is subject to approval by the Extraordinary General Meeting on April 25, 2024.
The issue is guaranteed to approximately 63 percent through subscription commitments and guarantee commitments from existing owners and members of the company’s management and Board of Directors, among others.
The first quarter of 2024 continued to be positive and eventful, in line with full-year 2023. AlzeCure continued to make good progress in all Alzheimer’s and pain projects and in 2023 we
also presented favorable Phase II clinical results for ACD440 for the treatment of peripheral neuropathic pain. We are now facing another exciting year in AlzeCure’s development and the strong support from our major shareholders is very encouraging. We are also extremely pleased about the strong support we have received from Dr. Jan Lundberg, who has chosen to invest in us and would like to become actively engaged in the company’s Board of Directors. Jan 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.
Jan Lundberg has also been a professor at Karolinska Institutet and has published over 500 scientific articles. He also advises several international investment funds, including Rhenman and Partners. The new share issue will secure the funds needed to implement several value-creating development steps in our research portfolio, as well as for out-licensing and partnership activities
Stockholm, April 2024
Martin Jönsson