After almost two months as a listed company, Arcede Pharma releases its first quarterly report. The first – and slightly shortened – quarter of the fiscal year has been marked by the spin-off from Respiratorius, but CEO Mia Lundblad also provides some operational updates. Among other things, she gives us some insight into the toxicological studies that are currently underway.
The development company Arcede Pharma originates from Respiratorius’ original business, with the goal of developing the next generation of drugs for chronic obstructive pulmonary disease (COPD) and severe asthma. In early summer, it was time for the two companies to go their separate ways and for Arcede, with CEO Mia Lundblad at the helm, to move forward as an independent company.
The portfolio is fully focused on the main candidate RCD405 – a substance that has both bronchodilating and anti-inflammatory effects. This distinguishes it from the drugs available today that basically have only one mechanism of action and where the treatment regimen consists of combining different drugs to get the desired effect.
It is no small market that the company is aiming for. Drugs that treat various respiratory diseases account for almost 10 per cent of all the world’s drug sales and among the respiratory diseases, COPD and severe asthma account for about half.
Continued progress in the preclinical development of RCD405
In addition to being listed on the stock exchange, the focus for Arcede Pharma has been on the continued development of RCD405. The company states that it has obtained a significant amount of new pharmacological data that has further increased the understanding of the active substance’s mechanisms of action.
From the toxicology program, the company reports that it has now completed the first of the two 4-week studies. No unexpected or undesirable effects have been observed so far. Further sub-studies are still ongoing before the final 4-week study can begin. Once all toxicological studies have been fully completed and all samples analysed, the results can be analysed, and a full evaluation can be made. In addition to being a prerequisite for starting clinical phase I studies, the results from the toxicology program will also give indication of how the clinical studies should be designed.
RCD405 well suited for inhalation
The collaboration with Lund-based Iconovo is also progressing according to plan and the first part of the contracted formulation studies is now completed. Work will soon begin on clinical development with API production, pulverisation and optimisation of the final formulation. As BioStock has previously reported, the drug candidate is described as having good properties for easy mixing with known excipients and then inhaled using Iconovo’s disposable inhalers.
“This bodes well for the upcoming clinical studies as we probably only need to make simple adjustments and improvements regarding the final inhaled product,” Mia Lundblad states in the report for the first quarter of the fiscal year 2022-2023.
Patent approval in South Africa
Arcede also reports that the company has received approval from the South African Patent Office for the RESP9000 series, which is the series of substances in which RCD405 is included. The RESP9000 series has already received patent approval in several European countries.
Arcede Pharma is starting the stock market journey with stable finances
Looking at the financial side of Arcede Pharma, the operating profit came in at just under -1.9 MSEK for the first quarter of the year. As this will be the first quarter as an independent company, there are no relevant comparisons to be made to the same period last year. However, the company exited the period with a cash position of just over 23 MSEK.
Comments from the CEO
BioStock contacted Mia Lundblad to get her view on Arcede Pharma’s first quarter as a listed company.
You have just completed the first quarter on the stock exchange. How would you describe the past quarter?
– It has been intense and instructive, but it has been very exciting in terms of scientific work. We have a lot of new and important data that has taught us more about how RCD405 actually works.
Can you say something about the new findings?
– We now know more specifically which receptors are involved in the bronchodilator effect and have also gained further knowledge of which inflammatory substances are affected by RCD405.
How do you expect Arcede’s autumn to be?
– Autumn will be intense as we will prepare as much as possible for the clinical development, which will commence as soon as we have obtained all the results from the the toxicology studies. The ongoing toxicology studies are extensive and take time as the doses has to be repeated over a long period of time, so it will be soThe 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.