Focus on company split for Respiratorius during Q4
Lund-based Respiratorius is currently undergoing an extensive transformation where the company’s two development projects are being separated. That process set the tone for the company’s report for the fourth quarter of the fiscal year 2021/2022, which this time included four months, instead of the customary three. BioStock contacted Respiratorius’ CEO Johan Drott to find out more about what is going during this transformative time for the company.
For several years, development company Respiratorius has run two very different projects, where VAL001 is being developed for the treatment of diffuse large-cell B-cell lymphoma (DLBCL), and where RCD405 is being developed for the treatment of chronic obstructive pulmonary disease (COPD). Whilst the projects have long advanced under the same umbrella, the time has come to separate the two.
The new subsidiary containing the respiratory assets will be named Arcede Pharma and will be spun off to Respiratorius’ shareholders during the summer. Forty-five MSEK was also injected in order to be able to continue running the two projects.
PK study with VAL001 advance according to plan
For VAL001, a pharmacokinetic study is currently underway in Finland with the new formulation. Preliminary results have been reviewed by the Internal Safety Review Committee, which has made the assessment that the relatively high doses of VAL001 given to patients are safe and that the expected concentrations are achieved. The timetable for the study thus remains and the study is expected to last into the second quarter of the fiscal year.
Work on the new formulation – where the immediate release is combined with a delayed release – is an important component in the project in order for the candidate to differ clearly from generics.
During the quarter, Respiratorius also conducted laboratory trials to study the efficacy of valproate in combination with R-CHOEP, which is an intensified chemotherapy treatment given to DLBCL patients who are under 70 years of age with medium or high disease risk. The candidate has previously shown clear efficacy in combination with today’s standard treatment R-CHOP, but the latest findings indicate that the candidate could also add value to this intensified treatment.
Patent for the RESP9000 series formally granted
Work on RCD405 is progressing in collaboration with Iconovo, where they are currently looking at how the active substance can be formulated. According to the company, the work is now entering a new phase that will run in parallel with extensive toxicological studies, which is a prerequisite for entering clinical studies.
The latest update in the project is that the European Patent Office (EPO) has now formally granted patents for the RESP9000 series, which means that Respiratorius has market exclusivity for the project in Europe until 2039.
CEO comments
BioStock contacted Respiratorius’ CEO Johan Drott to ask some questions about the latest and somewhat extended quarter.
First of all, Johan, how would you describe the past quarter?
– In terms of administration it has been a very intense period, with a strong team that has managed to keep a very tight schedule. In parallel, we have also advanced both development projects with good results.
In addition to everything that is going on internally, Europe has been hit by a war. How has that affected you?
– It is an extremely tragic development with the war in Ukraine with unimaginable human suffering. The war also creates uncertainty for all companies and Respiratorius is also affected by the financial uncertainty. Despite this, we were able to secure funding for both Respiratorius and the initial financing of Arcede Pharma.
You have seen indications that VAL001 may also be relevant in combination with R-CHOEP. What does that mean for the project and how do you pursue that?
– Being able to demonstrate that there is a good basis for valproate to work clinically in combination with R-CHOEP in lab experiments is of course good. This must be validated in clinical studies where it is possible to include both R-CHOP and R-CHOEP patients in a phase III study, following initial establishment of the maximum tolerated dose of VAL001 in combination with R-CHOEP.
– If VAL001 shows as good an effect as with R-CHOP, it would be very positive also for high-risk patients treated with R-CHOEP.
– In the situation we are in today, where we are focusing on a licensing agreement, this means that we have potentially broadened the patient group and probably also improved the recruitment rate in a phase III study, by being able to also include high-risk patients.
In the report, you write that the work together with Iconovo is entering a new phase. What does that mean?
– The initial evaluation of the substance from a formulation perspective was successful. Now, we have started to evaluate which mixture ratios of active substance and excipients are possible, as well as evaluate the dosage of RCD405 using inhalers.
What milestones will be important to keep an eye on for the rest of the year?
– I’m hoping for good news around patents and further approvals.
– We have quite a few technical milestones for RCD405, which are of course important, but perhaps of more limited interest to the market. However, I expect that the market will be well informed about the continued development going forward.
– For VAL001, we have an important milestone in completing the PK study, where we expect the last patient to be dosed in Q2.
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