Respiratorius CEO: “We continue to reduce risk in the project”
The partnering process continues for Respiratorius, which recently released the report for the third quarter. The US patent has been approved and the focus is now on refining the VAL001 project, with a particular focus on the regulatory aspects.
– We have a clear strategy to clarify and strengthen the company’s values as well as a clear regulatory strategy, says Johan Drott to BioStock.
Lund-based Respiratorius is developing VAL001 for the treatment of diffuse large B-cell lymphoma. The drug candidate is intended as a pre-treatment to the standard treatment R-CHOP, and backed by positive phase I/IIa data, the company has been recommended to go directly to phase III and then submit all documentation for a market approval. The company has identified a potential partner willing to co-finance the study and is actively working to secure additional partners to join in this journey.
In the Q3 report, CEO Johan Drott writes that the company has initiated work to “refine and strengthen the value of VAL001”, with a particular focus on a regulatory strategy that is in line with the expectations of the regulatory authorities.
Several initiatives reduce risk
– Overall, you can say that this work revolves around identifying and reducing risks and uncertainties in the project as much as possible, says Johan in an interview with BioStock.
– The work is addressing questions that have arisen during contacts with potential partners. It is important to listen and learn to straighten out any question marks and make the package as attractive as possible to a partner. In the dialogue with potential partners, issues are raised that we are gradually addressing, and the regulatory aspect is an example of this.
Another example is the new formulation of VAL001 that has been developed – combining immediate and delayed-release of sodium valproate. Initially, the project consisted largely of data showing that sodium valproate was promising in combination with chemotherapy.
In addition to the fact that PK data has shown that the new formulation is more advantageous, compared to available formulations of valproate, it also means that Respiratorius now has its own well-defined product. A further consequence is that the protection of the innovation can now be extended further.
Patent protection strengthened
Speaking of IP protection, Respiratorius was finally able to obtain the long-awaited US patent for the oral formulation of sodium valproate during the quarter. The review process has been unusually lengthy and complicated, with several objections from examiners at the U.S. Patent and Trademark Office. However, by means of an appeal to the Board of Appeal, Respiratorius had all the objections repealed, which paved the way for the approval.
This formulation of sodium valproate is now protected in the United States, Japan and Canada, and the process is also underway for the European market.
– My experience in partnering processes is that it is important that patent applications are alive. Approvals are positive, of course, but it is not decisive. With active applications, you can do a lot along the way, as they are living documents. Therefore, it was important for us to bring the US application back to life, as the examiner had previously closed it.
New application will further increase protection
The company has also submitted a patent application for the fully developed product and details of the formulation to achieve optimal release of valproate for the intended use as a pre-treatment. That application recently reached the international stage.
– I can not say anything about when we would be able to get an approval decision, but what we know from the preliminary review is that it looks good.
Funding secured for 2025
If we look at the financial part of the report, cash flow during the quarter amounted to approximately SEK -1.7 million, which led to that the cash at the end of the period amounted to just over SEK 9 million.
– With the capital raise in the spring, we now have enough funds to carry out the activities we planned for this and next year, concludes Johan Drott.
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.
