Arcede Pharma has developed the drug candidate RCD405, which targets the treatment of chronic obstructive pulmonary disease (COPD) and severe asthma, two serious diseases that affect millions of people globally. Despite a large existing treatment market, there is a great need for new medicines that specifically target the underlying causes of these diseases, especially the inflammatory aspect.
RCD405 differs from existing treatments through its dual mechanism of action, as it has both bronchodilating and anti-inflammatory effects.
Toxicology program completed
Arcede Pharma was able to complete the toxicological studies with the drug candidate during the autumn and now the results have also been received. RCD405 has been shown to be well tolerated in an earlier part of the toxicological program and the results from the second part confirm this. The preclinical studies have been conducted in collaboration with a recognized contract laboratory and in accordance with Good Laboratory Practice (GLP).
The drug candidate was shown to be well tolerated in repeated doses over a period of four weeks. This means that the company has now passed all the toxicological studies required to initiate Phase I clinical trials.
Aiming for an effective phase I study
The results, together with data from other ongoing studies, will form the basis for determining the therapeutic dose and concentration range and safety margins for future studies in humans.
Among other things, the company is currently conducting studies aimed at gaining a better understanding of the relationship between dose, concentration and effect. The knowledge from this will then be used to design the most effective first clinical study possible. It is planned to include both healthy volunteers and patients, in order to get an indication of the effect as early as possible.
New results confirm the candidate's efficacy
In the preclinical work, which is carried out together with research groups at Lunds university and Karolinska Institute, also looked at the effect. The results from the studies show a clear airway relaxing and anti-inflammatory effect of RCD405, something that they hope to be able to publish in one of the scientific journals that monitor the respiratory development field.
Comments from the CEO
BioStock contacted Arcede Pharma's CEO Mia Lundblad to find out more about the latest milestone and how she sees the path forward for the drug candidate.
First of all, Mia, how do you feel about having now reached this preclinical milestone?
– This is of course very positive and absolutely crucial for reaching the clinic and something that we have been waiting for for a long time. This is the result that eliminates a significant part of the risks that always exist in early projects in drug development.
Regarding the new preclinical results you have received regarding RCD405, how do they compare to the results you have obtained in previous studies?
– There have also been no indications in any of the previous studies that would indicate any unexpected effects, so this latest study confirms previous results showing that RCD405 is a safe substance from a side effect perspective. In addition, we have generated positive efficacy data from several in vivo trials that confirm results from previous ex vivo studies.-study.
Is it possible to say anything about how the results relate to what is seen in existing drugs?
– It is really only in the clinic, in direct comparative studies, that one can say with certainty something more definitive about the final effect in humans, and compare clinically significant effects. Since RCD405 has a completely new and unique mechanism of action with dual effects, it is difficult to compare with other drugs in preclinical trials, since then you are basically comparing apples to oranges.
– However, in some of the studies we have used certain reference drugs and observed corresponding effects of RCD405 on, for example, several anti-inflammatory parameters.
You are currently conducting studies to determine the right dose and concentration of RCD405. Can you tell us a little more about that work and how the thinking goes there?
– These are studies where in the same study you study both the effect (e.g. airway relaxation) and the concentration (both locally in the lungs and in the blood) of your substance over time. This allows you to establish a concentration-effect relationship that is then used, together with other data, to predict the doses needed to get the expected effects in humans.
What does the timeline look like in that work?
– The major time-consuming work that now lies ahead of us consists primarily of scaling up the manufacturing process, in accordance with current quality requirements. We are therefore completely dependent on external contract laboratories and their capacity and resources. However, we naturally hope that this can be done as soon as possible.
And in the next step, when do you hope to initiate Phase I studies with RCD405?
– As we are dependent on having the above-mentioned manufacturing completed and controlled, it is difficult to fully predict the time required, but we hope to be able to have approval to start the study in the latter half of 2024.