The AlzeCure team continues to make good progress according to plan, in high-profile areas that are becoming increasingly relevant, such as the US Food and Drug Administration’s (FDA) approval of a new drug for Alzheimer’s disease, the first in 18 years, which is expected to boost interest in the Alzheimer’s field.
During the second quarter, we communicated positive data from our Phase Ib clinical trial of ACD440 for neuro- pathic pain and are now preparing for a Phase II trial and a pre-IND meeting with the FDA. We also focused on running the Phase I clinical trial for ACD856 in Alzheimer’s disease and on further developing compounds in our pre- clinical pain project, TrkA-NAM, with the aim of choosing a drug candidate for the project in the second half of 2021. Thus we have once again closed the books on yet another positive and very active quarter at AlzeCure.
AlzeCure continued to develop according to plan and during the second quarter, we had a positive and significant readout in our Phase Ib clinical trial with ACD440 for neuropathic pain, a project we are now preparing for a Phase II trial and a meeting with the FDA.
Martin Jönsson, CEO
With the FDA approval of the Alzheimer’s drug Aduhelm™ (adu- canumab) in June, and the two Alzheimer’s drugs donanemab and lecanemab granted Breakthrough Designation from the FDA, interest in Alzheimer’s disease continues to increase. This growing interest is evident among private investors, institutions and pharma- ceutical companies. The annual price of treatment for Aduhelm in the US has been set at USD 56,000. If the drug is prescribed to only 5 percent of diagnosed Alzheimer’s patients in the US at this cost, Aduhelm is expected to become the second largest drug in the US, with annual sales of USD 17 billion (Nature, June 8, 2021). This shows the huge economic potential in the field of Alzheimer’s.
Through its decisions and announcements, the FDA has demon- strated its understanding of the great medical need in this area and its support for the amyloid hypothesis: that the build-up of harmful amyloid beta in the brain plays a fundamental role in the development of Alzheimer’s disease. Aducanumab, donanemab and lecanemab are all antibody therapies aimed at clearing harm- ful amyloid beta in the brain.
The FDA decision is favorable for AlzeCure and our Alzheimer’s projects within our Alzstatin and NeuroRestore research platforms. We see great advantages in our projects, which are based on small molecule programs: they do not require invasive administration in the inpatient setting, but can be taken as a tablet at home; they can be designed to better penetrate the blood-brain barrier; they are potentially more cost-effective compared with biologics and, in the case of Alzstatin, it may even prevent disease. With the demen- tia and Alzheimer’s patient population expected to triple over the next 30 years, and already amounting to 50 million patients world- wide, there is high demand for preventive medicines that prevent damage to brain structures and are not resource-intensive.
Our Alzstatin platform aims to develop preventive diseasemodify- ing treatments for Alzheimer’s by reducing production of harmful amyloid-beta and thereby preventing accumulation of pathological amyloid in the brain. In the Alzstatin program we have preclinical studies that have shown that we can reduce the quantity of harm- ful amyloid-beta by 50 percent. ACD679 is currently undergoing preclinical toxicological studies, at the same time that research continues in the ACD680 follow-up project. This development project will ensure that we can choose the best possible Alzstatin compound for future clinical trials.
ACD856 is part of the innovative NeuroRestore platform with a primary focus on symptomatic treatment of Alzheimer’s – in other words, improving the memory and cognitive problems that are so characteristic of the disease. In the ongoing clinical trial for ACD856 we are assessing safety and tolerability, where we expect the initial results during the summer of 2021. Our other drug candidate in the NeuroRestore platform, ACD857, is in the preclinical develop- ment phase. We plan to develop this compound for an indication within the field of cognitive dysfunction, such as Alzheimer’s disease.
We also see continued promising progress in our pain platform Painless, which consists of two projects, ACD440 and TrkA-NAM. ACD440 is a VR1 antagonist for topical use aimed at treating neuropathic pain. In December 2020, we initiated a Phase Ib clinical trial with ACD440 and in April, ahead of schedule, we were able to report positive and significant safety and tolerability results and demonstrate early efficacy signals. The neuropathic pain indi- cation currently generates global pharmaceutical sales of USD 10.8 billion in 2020 and is expected to grow significantly to over USD 25 billion by 2027 (GlobalData, 2021).
Research shows that half of patients with neuropathic pain today do not achieve adequate pain relief. This indicates the great unmet medical need, as well as the potential in this field and for our ACD440 project. We are now preparing for a pre-IND meeting with the FDA in the autumn in order to be able to apply to initiate a Phase II study by the end of this year. The patients we intend to treat suffer from chronic pain, a patient population that is expected to continue to grow, in part due to the aging population.
TrkA-NAM, our second pain project within the Painless platform, is aimed at treating severe pain conditions. One example is osteoarthritis, which is estimated to affect over 250 million people. After having received positive efficacy data from our preclinical pain stud- ies, we are now actively working to select a final drug candidate for the project, which we expect to do during the second half of 2021.
During the quarter we continued to have a strong focus on mar- keting communication and participated in several meetings and events. In May, we arranged a symposium at Redeye with a focus on pain. The symposium was very well received and is recorded and available on our website. During the quarter, we also pub- lished several papers, including abstracts and posters that were accepted at scientific congresses. These venues include the AAIC Alzheimer’s Congress and the IASP World Congress on Pain, demonstrating the interest in and the scientific quality of the data we generate. We are constantly working on reaching out to both private and institutional investors, as well as other pharmaceutical and research companies that may be interested in investing in or in-licensing our development projects, or alternatively, in entering into a partnership.
The Board of Directors has also added a new member, Eva Lilienberg, to strengthen the AlzeCure organization. Eva has extensive com- mercial and international experience in all aspects of clinical drug development with an emphasis on regulatory affairs, which is important as we advance our development projects and prepare to become a Phase II company
I am pleased to report that AlzeCure continues to make good progress together with our talented, dedicated and motivated employees. We have several promising projects under develop- ment, all within fields with great unmet medical need, which is incredibly motivating. The performance we achieved to date strengthens our conviction that we shall be able to deliver as stated in our communicated objectives during the year.
Stockholm, August 2021