Arcede Pharma has developed the drug candidate RCD405 to primarily address chronic obstructive pulmonary disease (COPD), a disease that affects millions of people worldwide and poses a significant healthcare challenge.
RCD405 differs from current treatments through its dual mechanism of action, which is both bronchodilator and anti-inflammatory, which has the potential to not only improve symptoms but also affect the root causes of the disease.
Finished with the tox studies
Arcede Pharma was able to complete the toxicology studies with RCD405 during the fall and the results show that the candidate is well tolerated. This means that the company has now met all requirements to be able to start clinical phase I studies and the hope is to receive approval to start the study in the second half of 2024.
Taking the next step in working together with Iconovo
An important part of the preparations for the clinical studies is the formulation work with RCD405, where Arcede Pharma works together with Iconovo. In this work, Iconovo has been responsible for the formulation work where the candidate has been adapted to the two inhaler platforms ICOone and ICOcap. A wide dose range has been achieved, from very low to very high doses. In the next step, a technical stability study will be conducted, after which RCD405 will be ready for clinical studies.
"With the positive results from the toxicology study, we have now successfully completed all the regulatory toxicology studies required to advance RCD405 to the clinical phase, which is a crucial, and value-adding, step in our work to take the project further in development, and towards the goal of improving the treatment of patients with COPD," writes Mia Lundblad, CEO of Arcede Pharma, in a comment on the news.
"We are very pleased that, together with Arcede Pharma, we have succeeded in developing a drug formulation that can be tested in a wide dose range in two different inhalers. This bodes well for the first clinical trials that can be initiated after a technical stability study has been conducted," writes Iconovo's CEO. Johan Waborg, in a press release.