The Board of Directors and the Chief Executive Officer of Alzinova AB hereby present the interim report for the period January -September 2021.
Alzinova is now a clinical-phase, Swedish biopharma company. We have achieved an important milestone with the start of the first clinical study with the oligomer-specific ALZ-101 vaccine in patients with Alzheimer's disease.
We are very pleased that during the third quarter we reached our goal to obtain an approval from the Finnish Medicines Agency Fimea to initiate the clinical study. We have now initiated the study and, as such we have entered the clinical development phase. Many of us have been looking forward to this moment which gives more hope to the millions of Alzheimer's patients, their friends and families and care givers who are suffering from this debilitating disease.
The aim of the clinical study with ALZ-101 is to evaluate the vaccine candidate's tolerability and safety. We will also study the immunological response to the vaccine after multiple doses, as well as a number of biomarkers that are associated with Alzheimer's disease. The study will be carried out in Finland in collaboration with Alzinova's partner, Clinical Research Services Turku (CRST), who have extensive experience in Alzheimer's studies.
The analysis of biomarkers will be made through a research collaboration with Sahlgrenska University Hospital in Gothenburg, Sweden. Topline data for the study is anticipated in the second half of 2023.
The first approved antibody against amyloid-ß (aducanumab from Biogen) for the treatment of Alzheimer's disease is now on the market in the USA. However, the significant cost of treatment and its debated efficacy have led to a low prescription rate being reported. In addition, as with other late-phase development antibodies, aducanumab causes adverse effects such as ARIA-E, which is a form of brain swelling. Consequently, several of these medicines need to be titrated, i.e. administered to the patient in progressively increasing doses, due to the risk of adverse effects.
We are convinced that a therapeutic vaccine, such as ALZ-101, that stimulates the body to generate its own antibodies specifically targeting the neurotoxic oligomers of Aß, can avoid the adverse effects described above and will also prove to be more effective. As a result, it will be a therapy that is long-acting, user-friendly and significantly more cost effective than the antibodies that are approved or in development.
During the year, pharmaceutical companies have had interactions with the Food and Drug Administration (FDA) in the USA regarding their Alzheimer's disease programs. These companies are now planning to apply for accelerated approval based on biomarkers. Alzinova will also benefit from this when we discuss our development programs with the FDA. Regulatory acceptance of biomarkers can considerably reduce time to market and enable patients with Alzheimer's disease to access an effective and long-acting medicine faster.
In the future, we believe there will be a need for several different types of medicines to treat Alzheimer's disease. As such, we see there is a potential need for both our vaccine, ALZ-101, and our antibody, ALZ-201. We are continuing with the humanisation of the antibody which will support it's progression as the next candidate we evaluate in humans.
Our financial situation remains stable. The fixed costs mainly consist of relatively low operating costs. R&D activities are progressing according to plan. We believe that the current liquidity, together with the capital we expect at the beginning of 2022 through the outstanding subscription warrants program, will ensure the completion of the clinical phase 1b study and the next planned development work for ALZ-101.
To minimise time to market, we are also continuing with the preparatory activities for phase 2, which is an important part of our partnering strategy. A strategic partner can thereby quickly start the next phase of clinical development without further time-consuming preparations.
Kristina Torfgård, CEO Alzinova
The full report, which is attached in the press release, can also be downloaded from the company's English website, www.alzinova.com/investors/financial-reports/
For more information, please contact:
Kristina Torfgård, VD
tel: +46 708 46 79 75
Håkan Skogström, CFO
tel: +46 705 85 08 59
The information was submitted for publication, through the agency of the contact person set out above, at 08:01 a.m. CEST on October 28, 2021.
About Alzinova AB
Alzinova AB is a Swedish clinical-stage biopharma company specializing in the treatment of Alzheimer's disease targeting neurotoxic amyloid-β oligomers. The lead candidate, ALZ-101, is being developed as a therapeutic vaccine for the treatment of Alzheimer's. Alzinova's proprietary AβCC peptide™ technology enables the development of disease-modifying therapies that target the toxic amyloid-β oligomers involved in the onset and progression of the disease with high precision. Alzheimer's is one of the most common and devastating neurological diseases globally, with of the order of 40 million people afflicted today. In addition, the antibody ALZ-201 is in early preclinical development, and the ambition is to expand the pipeline further. The company's Certified Advisor on Nasdaq First North Growth Market is Corpura