It has been an eventful spring for Lund-based drug developer Respiratorius. The company’s main candidate VAL001 continues to advance towards phase III studies, whilst several important milestones have been reached for the lung project RCD405, which previously went under the project name RESP9000. BioStock contacted the company’s CEO Johan Drott to get his view on the beginning of 2021 and hear what he envisions for the rest of the year.
Biotech Respiratorius has two drug candidates in its pipeline. The first and furthest advanced is VAL001, which is being developed for the treatment of diffuse large-cell B-cell lymphoma (DLBCL). The second project, RCD405, aims to find a new treatment for COPD and severe asthma, a mature treatment market but one with a great need to find new mechanisms of action. Those who have followed Respiratorius for a long time know RCD405 as RESP9000, but that name has now been abandoned in favour of RCD405, which is the specific drug candidate in the RESP9000 project.
As the company is currently looking for a partner for the VAL001 project, increasing operational focus is being placed on RCD405. However, this does not mean that VAL001 is put on ice during the search for a partner. The company recently signed an agreement with a clinical contract research organisation regarding the pharmacokinetic bridging study with the new formulation of VAL001. The study is expected to obtain approval to begin in the autumn. To finance the study, the company recently carried out an issue aimed at a number of international investors raising 25 MSEK.
Taking important steps in the patent process
VAL001 has previously received orphan drug status in Europe and the United States and additionally has patent protection in the United States, Europe, Japan, Canada, and Korea. The company has also applied for a patent regarding the formulation that is now under development. During the spring, the company has been able to respond to injunctions in several countries with strong arguments, an important step in the process of getting the patent approved.
Collaborating on new inhalation product
For RCD405, an important milestone was recently reached with the collaboration agreement with Iconovo, where the two companies will develop a product based on Respiratorius’ drug candidate and Iconovo’s inhaler ICOone.
During spring, the company also recorded promising results in the preclinical studies that are now being carried out. Among other things, a study was performed on lung tissue from rats where RCD405 showed the correspondin good effect that has previously been achieved in internal preclinical trials. The next step will be to test the candidate in lung tissue from dogs and humans. The ongoing patent process seems to run smoothly in this project as well and the company has only handled formal comments from the countries where applications have been submitted.
Ongoing warrant exercise
Another important milestone for Respiratorius is the exercise of the warrants of series TO1 that were issued in connection with the unit issue carried out in June last year. The exercise period for the warrants runs until July 5 and will, when fully exercised, provide the company with approximately 18.9 MSEK.
BioStock has contacted Respiratorius’ CEO Johan Drott to hear more about his thoughts on the start of 2021 and what he sees ahead.
Johan, first of all, how would you sum up the first half of 2021?
– Given the conditions with an ongoing pandemic, the work with both VAL001 and RCD405 has gone well. Above all, we have obtained very positive safety data for the extensive preclinical documentation.
It seems like we might be nearing the end of the Covid pandemic, is there anything in particular that you as the CEO of Respiratorius will take with you looking back on the pandemic?
– For us the challenges brought on by the pandemic have above all been that equipment at the various contract laboratories we work with has not been able receive service and maintenance due to travel restrictions. This has led to a demand for flexibility and creativity. We also see that much can be solved in web meetings, but physical meetings have their given place in the development work.
Finally, what activities do you see as the most important for the rest of the year?
– I see the PK study for VAL001 as very important. We hope to be able to show that we have a product dedicated to the new indication (DLBCL) as well as an approved patent.
– For RCD405 it is also important to start the large toxicological studies in animals where we are to confirm the safety of RCD405 as an inhaled drug.
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