After good results in the PK study with VAL001, only one activity remains for Respiratorius, to sign an agreement. In a quarter with a relatively low news flow, focus has been on the partnering process, a process that many follow with tense anticipation. BioStock contacted CEO Johan Drott for a comment in connection with the recently released Q1 report.
Lund-based Respiratorius develops VAL001, a drug candidate intended to be used as a pretreatment to today’s standard treatment of diffuse large B-cell lymphoma – R-CHOP. After very promising results in the company’s clinical phase I/IIa study, the European Medicines Agency recommended that the company take the project directly to phase III and only conduct a pivotal phase III study before applying for marketing approval. Standard procedure is otherwise two pivotal phase III studies before applying for marketing approval.
Key results from the PK study
In January, the company could also present good results in the PK study with the new formulation of VAL001. This means that not only does the company have promising clinical efficacy data, but also a product that is clearly differentiated from generic valproate.
The new formulation, with its two doses per day, gives an equivalent exposure to valproate as the reference medicine, which is dosed three times a day. The results of the PK study also indicated that VAL001 has a better effect than the reference medicine. You can see the company’s CEO Johan Drott’s comment on the latest results in an interview with BioStock here.
In the first quarterly report of 2023, Respiratorius states that the results from the PK study are an important component when attempting to sell the project.
Partnering process in full swing
The next step for Respiratorius will be to find a partner to take the development further, either in the form of a license agreement or acquisition of the project. Together with Alira Health, they are right now in the midst of trying to find a partner.
“It may seem as a trivial matter to reach an agreement with all the strong results as support. However, the reality is more complicated and despite intensive work, we unfortunately do not yet have an agreement to present”, writes CEO Johan Drott in the Q1 report.
In terms of news, it has been a relatively slow quarter, as full focus is now on the partnering process. However, Respiratorius recently announced that Chairman of the Board Niklas Prager is handing over to former Respiratorius CEO Karin Wehlin. The change is due to the fact that Prager was recently appointed CEO of the biotech company SmartCella. Wehlin has, in addition to her previous role as CEO of Respiratorius, co-founded EQL Pharma, where she was the Chairman of the Board for 10 years.
BioStock contacted Respiratorius’ current CEO Johan Drott for a comment on the quarterly report and his view of the company’s exciting situation.
The process of finding a partner is in full swing. Can you tell us a little about what interest you see in the project?
– The feedback we have received is that we have strong data. The challenge, despite the good results, is the size and duration of the phase III study required for marketing approval. This certainly also applies to competing drug candidates, but the fact remains that a major commitment is expected.
What do you see as important in a partnership agreement?
– The need for a commercially viable partner with the capacity to complete clinical development.
You recently announced Karin Wehlin as the new Chairman of the Board. What will she mainly contribute to the situation you are in?
– I am convinced that Karin will be an asset with the right skills and experience. She has, both operationally and from the board, completed several commercially important agreements and been instrumental in building successes such as BoMill and EQL Pharma.
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