Last fall, Dr Kirsten Harting joined Alzinova as the new Chief Medical Officer (CMO). Harting brings profound expertise from working with brain disorders including Alzheimer’s disease as well as knowledge about vaccines and immunotherapy. Roughly a half year into her tenure as CMO, BioStock reached out to Kirsten to learn more about her ambitions to shape Alzinova’s trajectory as the company advances in its Alzheimer’s clinical trials.
At the heart of Alzinova’s goals lies the challenge of Alzheimer’s disease—a neurological condition that has remained elusive to effective treatments for decades. It is only in recent years that treatment options have been introduced to patients.
However, still no disease-modifying or preventive therapeutic vaccine has been developed and approved by the authorities, and this is where Alzinova hopes to make a difference.
The company is currently developing two drug candidates against Alzheimer’s disease, ALZ-101 and ALZ-201. The lead candidate ALZ-101 is a disease-modifying vaccine in clinical phase Ib, while the monoclonal antibody ALZ-201 is in preclinical development.
Positive topline data from the phase Ib study
In late November 2023, Alzinova announced successful top-line results from part A of the double-blind placebo-controlled phase Ib study with ALZ-101 26 patients with early Alzheimer’s disease were randomized to receive four doses of either 125 μg, ALZ-101 250 μg ALZ-101 or placebo over a 20-week period.
Topline results from part A (20 patients on ALZ-101 and 6 patients on placebo) showed, that ALZ-101 was well-tolerated and had an acceptable safety profile. The patients treated with the vaccine showed a rise in antibodies – increasing with the number of doses given – and a high immune responder rate. Amyloid-related imaging abnormalities (ARIA) were seen in the form of ARIA-H (micro-bleedings in the brain) – but no patients developed ARIA-E (localised brain swelling).
Read the interview with Alzinova’s CEO Kristina Torfgård from 4th December 2023, discussing the positive top-line results here. (in Swedish).
Comments from the CMO
On August 14, 2023, the Alzinova team was joined by Kirsten Harting, formerly Senior Medical Director at Cytoki Pharma, as the company’s Chief Medical Officer (CMO). Harting holds a medical degree and an executive MBA from Copenhagen Business School. With over three decades of expertise in medicine, clinical research, drug development and business growth, she has contributed to bringing new medicine to the market with Lundbeck, ALK, Novo Nordisk and various other companies.
BioStock reached out to Kirsten to learn about her first impressions of the company, and how she plans to support Alzinova’s future trajectory, heading into the more complex and exciting parts of the ongoing drug development.
Kirsten, to start with, what motivated you to join Alzinova, especially in the context of the challenges and opportunities in Alzheimer’s drug development?
– I think the field of disorders in the brain is very interesting. During the years we have obtained increasing knowledge and have managed to bring forward new medicine, which can treat the symptoms of many brain disorders. One of the areas, where real progress has been missing is within Alzheimer’s disease. Many both large and smaller companies have tried to develop new medicines for this devastating disease – but without success. But the recent years of research, understanding of the disease and drug development has brought new hope. To fulfil this huge unmet medical need, I want to be part of the “global team” around the world trying to solve the challenges within Alzheimer’s disease and bring forward treatment – and hopefully a vaccine against this disease. I think the ultimate goal is to try to prevent the symptoms and the progress of the disease. If we can treat the root cause of Alzheimer’s and vaccinate against the disease, this will make a huge impact on the elderly, their loved ones and society as a whole.
What lessons from your past experiences at big pharmaceutical companies like Lundbeck, Novo Nordisk, ALK and Pfizer help you in the role as Alzinova’s CMO?
– I think the most important learnings from developing a new medicine is to try to make the right decisions from the very beginning and all the way through the development process. What I mean is, that developing a medicine is like putting together a puzzle. You are constantly obtaining new knowledge, and in the end, you have an overview of the medicine and can hopefully offer it to patients. Another learning is to always make sound and ethically correct decisions. As a Medical Doctor, I always ask myself the question: “Will you prescribe this medicine to your parents and family members?” If the answer is: “Yes” – then it is the right decision. Otherwise, we need to investigate further or change direction. These two learnings have made me succeed in developing new medicine.
What challenges do you foresee in taking Alzinova’s candidates through clinical studies and to the market?
– As for the development of all new medicine, there are and will be a lot of challenges, that we need to overcome in order to make it to the market. Some of the challenges we might foresee, but others will evolve during clinical development. Here it is an advantage that I have a large experience from developing medicines for brain disorders including Alzheimer’s.
How do you plan to balance the business development aspects with clinical priorities, especially with your background in both areas?
– I see it as a strength, that I have the medical and scientific background, and therefore understand the disease and the patient. But I also of course have a profound understanding of how physicians think and prioritize when deciding what medication to offer for the specific patient. Alzheimer’s is a multifaceted disorder to treat and includes a lot of other initiatives besides the medical treatment. Besides, no medicine is for all patients – and that would also apply to the medicine we are developing at Alzinova. The patient should receive what is right for them. The other side of the coin is, that there should be a positive business case for Alzinova to develop new medicines and for society to introduce new Alzheimer medication. Of course, it is a huge task for Alzinova to develop medicines within this therapeutic area, but we hope that our clinical results from treating early Alzheimer patients will be so convincing, that big pharma companies want to take part in our development.
When you joined the company, you mentioned focusing on being the patient’s voice within the company’s management team in a press release. How can the patient perspective be integrated in designing clinical studies and in drug development strategies?
– I would actually turn your question around and say, that the patients’ voice should be fully integrated in everything we do. The profound understanding of the disorder itself and the quite many symptoms, that an Alzheimer’s patient may experience, must be fully understood. Otherwise, we cannot make the right clinical development plan. The clinical trials must deliver results important for the patient, the physician, the regulatory bodies, and the society (including payers). Even if price, reimbursement, and benefit for society is perhaps the next step after the clinical trial program, we must try to build in as much as possible – also in the early trials. Or at least you must have an overview about where you are going with your development, to make the right decisions along the way. As a Medical Doctor, the patients will always be my priority.
To wrap this up – in the next 5–10 years, what do you envision Alzinova’s role will be in treating and potentially preventing Alzheimer’s disease?
– I hope that we at Alzinova will contribute to a better elderly hood than the one we have today. We become older – in other words, we live longer today, compared to earlier generations. This is in itself very positive, but if the elderly years are spent as an Alzheimer patient with increasing memory loss, forget conversations, misplace items, get lost in places, that once used to know, forget the names of family members and everyday objects and have trouble finding the right words for objects and expressing thoughts or taking part in conversations – then perhaps the additional years are not years of good quality. I hope that we can prevent Alzheimer’s from developing into this devastating disorder by offering a vaccine to patients with early mild symptoms. I hope we can treat the root cause of Alzheimer’s and stop the aggravation or at least slow down the progression.The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.