Developing a so-called Target Product Profile is an important part of the drug development process, especially since it provides an early target and serves as a steering document for planning. A TTP can both reduce development time and costs, as well as attract partners and investors. Lipum is actively working with this for its drug candidate SOL-116 for the treatment of inflammatory diseases. BioStock had the opportunity to talk to Sven Undeland who is involved in this work at Lipum.
The biopharmaceutical company Lipum develops a biological drug with a new mechanism of action for the treatment of rheumatoid arthritis and other chronic inflammatory diseases. The company’s drug candidate SOL-116 is an antibody designed to block Bile Salt-Stimulated Lipase, an enzyme that has been shown to have a significant role in the inflammatory process. SOL-116 will soon be tested in humans for the first time in a phase I study in patients with rheumatoid arthritis (RA) and healthy volunteers.
SOL-116 has versatile potential
Lipum has chosen to focus its development work on the treatment of rheumatoid arthritis in adults and children. However, SOL-116 appears to have the potential to treat numerous other chronic inflammatory diseases and is therefore continuously evaluated for further indications. Proof of this is that Lipum is part of a research consortium to evaluate new treatments to reduce inflammation in cardiovascular diseases and breast cancer. The project is coordinated by the Cardiovascular Research Centre (CVRC) at Örebro University and was recently granted SEK 10 million from the Swedish Knowledge Foundation (KKS).
TPP – steering document during the development journey
Something that Lipum is working on extra intensively now that they are soon entering the clinical phase with SOL-116 is the update of their Target Product Profile (TPP), which is a valuable planning tool for the development of a drug:
»TPP is something that we work with and gradually refine during development and when new externalinformation arrives. Extra intense now that we are about to enter the clinical phase« – Einar Pontén, CEO, Lipum
According to the FDA, a TPP outlines the desired profile and characteristics of a product that targets one or more diseases. TPP is usually of good help to the project team and the entire organisation as it serves as a target image and provides a structure in the planning throughout the drug development. The most importantthing is that the benefits of the product (product differentiation) are shown so that one focuses on documenting these.
Key elemens in a TTP
The key thing in a TTP is to define the patient target group, i.e., the indication, that you plan to treat and what clinical results you want to achieve – should the new substance be better or equal to existing treatment?
Defining the patient target group at an early stage is essential – is the plan to treat the whole group or just a subgroup? It is also very important to understand the clinical needs within the indication. How good the new preparation must be determines how the clinical studies should be designed to get the preparation approved by the authorities, as well as to meet the requirements that payers have on a new preparation for them to be implemented in daily healthcare.
A TTP also describes the side effect profile, dosage form and dosage. A favourable side effect profile is a significant advantage in some indications where there are currently only drugs with many side effects that patients do not tolerate.
Several advantages of a TPP
There are clear advantages to developing a TPP as early as possible, at the latest when entering the clinical phase. In addition to structuring the planning, it also controls which areas to monitor commercially, such as competitors, study design and price levels in various indications. A well-thought-out TPP can facilitate internal decision-making within the organisation and create favourable conditions for interactions with external stakeholders such as regulatory authorities (e.g., FDA, EMA) and potential partners and investors. One ormore TPP makes you much better prepared to present and discuss your project.
Interview with Sven Undeland
A key member of Lipum’s team in the development of a TPP for SOL-116 is Sven Undeland. Sven has been active in the pharmaceutical industry for more than 20 years and has previously held leading roles at Orexo, AstraZeneca, Sanofi-Aventis and Pharmacia, among others. As a consultant, Sven Undeland offers strategic support to life science companies, including in their product strategy and TPP development, which he tells us more about in an interview with BioStock.
First of all, how is a Target Product Profile designed?
– I work with a “one-pager”, but it can look different within different companies. Just having a one-pager force the team to really focus on the core parts and improved properties compared to today’s treatment, i.e., where the product can make a difference.
– You can work with multiple TPPs if you see multiple opportunities (indications, subgroups).
– It is also a strength to have a minimal TPP, which is what you least must achieve to have a positive business case. If you do not achieve this, you should stop the project or at least rework the TPP and plans to see if you really have a product with potential.
Why is it important to develop a TPP early in the development of a drug?
– It forces the team to obtain information from the outside world about the intended disease to treat. Doing this “homework” early on brings many benefits, including more efficient planning, control monitoring of external events,etc. It is also important to update the TPP during development with both external and internal information.
What has the process been like in the development of SOL-116’s TTP?
– I attach a lot of importance to gathering information from outside, only internal TPPs have a low probability of becoming a good tool for the team. Much is available online and in databases that we have access to, but it is also very important to do surveys/interviews with different experts and participate in congresses etc.
If we look specifically at Lipum’s candidate SOL-116 – what does that TPP look like?
– We have developed a TPP for the lead indication, RA, and will develop more TPPs for other inflammatory indications.
– In the external analysis we have done, including interviews with international opinion leaders, we have obtained a clear picture of what clinical needs there are and what properties Lipum should focus on.
»If Lipum can meet the TPP for RA, SOL-116 is a +1 BUSD product. The other inflammatory diseases we are looking at also have very great potential.«
Finally, what is your view on the potential of Lipum’s drug candidate SOL-116?
– The RA indication has a tremendous market value of about 25 BUSD for the 7 major markets. If Lipum can meet the TPP for RA, SOL-116 is a +1 BUSD product. The other inflammatory diseases we are looking at also have very great potential. The most important thing is that we do good initial work and can describe the opportunities that SOL-116 has for potential partners and investors.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.