BioStock article: Aptahem’s new CRD brings clinical experience to Phase I

BioStock published an article on 29 April 2020 about Aptahem, which can be read in full below.

Aptahem, whose primary drug candidate Apta-1 is being developed as an acute treatment for sepsis, recently announced that it is expanding its team with Suzanne Kilany as Clinical Research Director. The recruitment comes as the company prepares to move into clinical development with its main candidate. Kilany, who most recently comes from a position as Medical Scientific Adviser (MSA) at Astellas Pharma, is also a long-time board member of the Swedish Pharmaceutical Society’s clinical studies department. Here, she tells BioStock more about her new role at Aptahem.

Suzanne Kilany has been hired as a consultant by Aptahem for the role as Clinical Research Director (CRD). Her job is to lead and coordinate the planning and preparation for the company’s upcoming phase I clinical trial with their drug candidate Apta-1. With its drug candidate, Aptahem wants to improve the treatment outcome in sepsis, a disease that kills 11 million people globally every year.

»Being able to sit on the board of the Swedish Pharmaceutical Society’s department for clinical studies means that I have a network of colleagues that I can turn to and it is also a very good way of keeping up to date on what is happening and what the requirements are« — Suzanne Kilany, CRD Aptahem

BioStock contacted Suzanne Kilany to find out more about why she chose to take on the challenge of leading the clinical development work at Aptahem, and what hopes she has for the candidate Apta-1.

Suzanne, congratulations on your new position! What made you accept this role?
– Most large companies conduct their early drug development outside Sweden, which means that I have mainly worked with the later development phases. Getting involved from the beginning in the development of a new drug candidate is incredibly exciting, and when I was offered the opportunity and the privilege of this assignment at Aptahem, it was not difficult to accept.

You have three decades of experience with clinical studies and clinical development work, including at pharma giant Astellas Pharma. What specific lessons do you take with you from your previous positions that may be useful in your new role as CRD at Aptahem?
– The most important lesson is that communication is absolutely crucial. Furthermore, that the work is a team effort regardless of which side of the table you are on and that everyone should feel involved in both the work and the results. There are many factors involved in the process; for example, several different government approvals are required for clinical development. It is also necessary to build networks and relationships with medical specialists and to build trust in Aptahem. It is a process that takes a lot of time. Thorough preparatory work is extremely important in order to achieve a good end result.

»The preclinical results show that Apta-1 is an interesting drug candidate even in other therapy areas such as osteoarthritis, viral infections and various types of cancer«

During your career, you have had extensive contacts with both pharmaceutical companies and contract research organisations, and, at the same time, you are a board member of the Swedish Pharmaceutical Society’s department for clinical studies. In what way will this benefit you in your future work?
– I bring with me the way of thinking from both clients and from contract companies. Above all, I have knowledge of the regulations and know that you have to be pragmatic in order to move forward with a maintained quality. Being able to sit on the board of the Swedish Pharmaceutical Society’s department for clinical studies means that I have a network of colleagues that I can turn to and it is also a very good way of keeping up to date on what is happening and what the requirements are.

What, in your opinion, makes Apta-1 interesting?
– Apta-1 is an aptamer-based drug candidate, and today there is only one registered aptamer product on the global market. There is a huge medical need for the intended treatment area and treatment indication for Apta-1. The preclinical results show that Apta-1 is an interesting drug candidate even in other therapy areas such as osteoarthritis, viral infections and various types of cancer.

Phase I clinical trials with Apta-1 are getting closer, and your primary task will be to lead and coordinate planning and preparation work ahead of this milestone. What will this mean in more concrete terms?
– I will of course work with the clinical development plan and, among other things, look at the best location for carrying out the phase I clinical trial and find the right CRO with the skills, qualifications and experience of conducting studies in critical conditions. The challenge is to find a measurable endpoint that is established and accepted by medical expertise, such as survival.

What milestones do you see ahead and how do you plan to ensure that these are reached?
– The basis for initiating clinic studies is largely already available, such as preclinical and toxicological studies. What remains in order to be able to proceed to clinical studies is the GLP-toxicology study. In the meantime, we are preparing the study design, taking in quotes and discussing with potential clinical investigators. As this is based on teamwork, everyone should be aware of the milestones and be constantly updated. It requires being proactive and one step ahead.

»The goal is to attract a licensing partner after completing phase I/II in order to continue the development. An alternative scenario is to find a partner before entering clinical studies, based on a precise development plan«

Apta-1 is being developed as an acute treatment for sepsis. How large do you think the need for a new drug within this indication is and do you think the public has a fair idea of ​​how deadly the disease is?
– Sepsis is a serious condition, which affects approximately 49 million people annually and kills 11 million each year. For Sweden, the corresponding figures from 2016 are 40,000 affected and about 8,000 (20 per cent) dead each year. The public is generally unaware of how deadly this condition is, or what it is. The number of patients diagnosed with sepsis hides a significant number of unrecorded cases as many underlying diseases can cause the condition, such as cancer, influenza infections and many more. There is a great need for a new drug for sepsis as it does not always have to be a deadly outcome, but the condition can have other lasting and, sometimes lifelong, consequences.

Finally, in terms of your new position, what awaits you in the near future?
– My focus right now is to first familiarise myself with the results that already exist and get to know the team. What I will address first is to create a development plan for Apta-1 that extends to clinical phase II and plan and prepare for phase I (First in Human, FiH). The goal is to attract a licensing partner after completing phase I/II in order to continue the development. An alternative scenario is to find a partner before entering clinical studies, based on a precise development plan.

Read the article at Biostock.se

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