Arcede approaching dosing in tox study
When reporting on first quarter of 2023, Arcede Pharma have an eventful period to look back on. Now all eyes are on the final part of the toxicology programme, where dosing starts in June. BioStock contacted CEO Mia Lundblad to hear her thoughts on the past quarter.
Drug developer Arcede Pharma is working on developing RCD405, a new dual-action drug candidate for the treatment of chronic obstructive pulmonary disease (COPD) and severe asthma. The candidate differs from existing treatments in that it acts as both airway relaxant and anti-inflammatory.
Tox study initiation
The project is currently in the final preclinical stage. Toxicological studies will determine whether the candidate is safe enough for use in humans. When Arcede reported the first part of the programme, it was shown that RCD405 is well tolerated and did not produce any unexpected effects or side effects. You can read more about the results here.
In the second part of the tox programme, the dosage is planned to take place in June. If everything goes according to plan, the study will last until mid-summer. The results need to be compiled and analysed in order for the reporting to happen according to schedule. However, the company says it will not be reported until the autumn.
Grant to increase the understanding of RCD405
In other words, Arcede are in an exciting phase of development, where they are on the brink of clinical studies. Among other things, the company also recently initiated a collaboration with Professor Arne Egesten at Lund University Hospital and the medtech company Iconovo.
Together they will gain a better understanding of how RCD405 works. They will also develop a dry powder formulation of the drug candidate. The project recently received a Vinnova grant of 2 MSEK. This will be paid out in installments starting in May 2023 and until February 2025.
In the report for the first quarter of 2023, CEO Mia Lundblad writes that she hopes that the work will lead to a better definition of the intended target group for the drug. As a result, you also get a better picture of market potential and potential future investors and partners.
Patent successes and stable finances
During the quarter, Arcede received positive patent notices from across the Atlantic. patent offices in Canada and the US have announced that they intend to approve the patent for the RESP9000 series in which RCD405 is included. The drug candidate is thus protected in the countries until 2039. The company already has approval in the EU, Japan and South Africa.
If we look at the financial part of the quarterly report, the result ended up at a loss of just over 2 MEK. Since the previous financial year was shortened with the spin-off from Respiratorius, there is no good comparison to make. At the end of the period, cash amounted to just over 14 MSEK.
CEO comments
BioStock contacted CEO Mia Lundblad in connection to the quarterly report to get her view of the past quarter.
First of all, Mia, how would you sum up the start of 2023?
– We have started several important and exciting activities through the collaboration with Lund University. In addition, we receive good support from our other advisor Professor Clive Page in terms of planning for clinical development. It is also positive that we have received patent approval in the US and Canada, which are large and strategically important markets.
When do you think you will be able to present results from the ongoing collaboration with Arne Egesten and his research group?
– Data is generated more or less continuously but cannot be presented in isolation. The results must be interpreted and put in context. Only when we have an overall picture and all the results in place can we make a conclusion. Their project part of the Vinnova grant expires at the end of the year, so by that time we should have an interpretation of the results.
If we look a little further ahead. Given a positive result in your tox study, what will be the next step in the work towards a clinic?
– To start production of API (Active Pharmaceutical Ingredient) according to GMP (Good Manufacturing Practice) standard and to package the formulation in the intended inhalers from Iconovo. In addition, a lot of paperwork is required to summarize all results in a so-called IB (Investigator’s Brochure), an IMPD (Investigational Medicinal Product Dossier) that describes the actual manufacture of our drug candidate as well as study preparations in the form of, among other things, study protocols and any meeting with the pharmaceutical authorities.
