Lund-based Arcede Pharma quietly been working away on the drug candidate RCD405 during the second quarter. The second part of the toxicology study is now underway, while the company is continuing preparations for the future beyond preclinical development. BioStock contacted CEO Mia Lundblad to find out more about what is happening in the company.
Arcede Pharma is developing RCD405, a drug candidate for the treatment of chronic obstructive pulmonary disease (COPD) and severe asthma. RCD405 differs from the currently available treatments with its dual mechanism of action. It has both airway relaxant and anti-inflammatory properties.
The company is in the final preclinical stage of development for RCD405. At this stage, toxicological studies are ongoing to determine the safety profile of the candidate. Initial reports from the first parts of the program have shown that RCD405 is well tolerated without any unexpected side effects.
The final study of the toxicology programme, which is required to start the first studies in humans, should be completed by the end of August. The results are expected to be reported in the latter part of the year.
Sees great market potential in RCD405
During the quarter, the company conducted an analysis of the drug candidate’s market potential. It confirmed the great unmet medical need within the COPD indication. It also identified an extensive group of undiagnosed patients. They could constitute a whole new group of patients who could be helped by drugs that affect the underlying cause of the disease.
In this context, it may be good to mention that drugs that treat various respiratory diseases account for almost 10 per cent of all the world’s pharmaceutical sales, which in 2021 corresponded to just under USD 80 billion. Medications for COPD and severe asthma make up about half of that sum.
Arcede Pharma is also continuing the work together with, among others, Professor Arne Egesten at Lund University, to gain a better understanding of the drug candidate’s mechanism of action. During the quarter, important progress has been made and the company hopes that data from the work will later be presented in a scientific journal.
Capital raise for the continued work
If we look at the income statement in the quarterly report, profit for the second quarter landed at approximately -3.4 MSEK. During the summer, the company announced that it intends to raise capital to continue the work towards clinical studies. In a first step, the aim is to raise 13.2 MSEK in a rights issue of units. The subscription period in the issue begins on August 24 and runs until September 8.
Comments from the CEO
BioStock contacted Arcede Pharma’s CEO Mia Lundblad to find out more about her take on the past quarter.
First of all, Mia, how would you describe the second quarter?
– We have conducted a lot of studies that have generated significant results regarding several important parameters, which provides an increased understanding of RCD405. These results will ultimately allow us to design the first clinical studies as optimally as possible and with the goal of being able to minimise the number of participants. An extensive market analysis has also been carried out.
– We have thus been very active, even if we have not communicated our progress publicly. The steps taken are part of a larger whole and must be explained and reported in a larger context together with other, in some cases previously compiled results.
During the autumn, you are expected to present the results of the tox study. What have you seen so far?
– So far, no unexpected clinical symptoms have been reported, even at the very highest doses, which is very promising. However, until all analyses have been carried out and all data and results are available, it is difficult to draw conclusions.
– Of course, we hope that in this final study we do not see any unexpected effects and the conclusion of all toxicology studies will thus show how high concentrations of RCD405 we can achieve without it entailing any risks.
You have also looked at the market potential for RCD405. What is your rationale behind this work and what market potential do you see for the candidate?
– For us, it is important to understand the market and make an initial assessment and analysis of potential future sales levels, as this is an important part for many investors. Since we have a completely new and unique molecule, that could probably also be prescribed at an early stage of the disease, the hope is to reach an even larger market than current treatments do.
– In addition, the absolute number of COPD patients in the world is expected to increase in the coming decades. Taken together, these factors represent enormous market opportunities while a large number of patients, both new and existing patient groups, can gain access to new and effective treatment.
You recently announced a rights issue of 13.2 MSEK. What will the issue proceeds be used for?
– The largest part will go to the manufacture of the drug itself, i.e., the production and formulation of RCD405, so that it can be appropriately dosed and administered in the upcoming clinical studies. The proceeds will also go to further preclinical studies needed to determine which doses and concentrations are needed to have an effect in humans.
– One part will also be used to compile all the documentation needed for the authorities to approve the first clinical study.The 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.