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Arcede aims for clinic with TO1

Arcede Pharma prepareds for phase I

Arcede aims for clinic with TO1

8 January, 2024

Preparations for clinical trials continue for the Lund-based drug developer Arcede Pharma. Right now, the focus is on finding the right dose and concentration of RCD405 to use in the upcoming phase I studies. January 8 to 19 is the exercise period for the TO1 warrant, which is intended to finance the preparations.

Arcede Pharma specialises in developing treatments for respiratory diseases such as chronic obstructive pulmonary disease (COPD). Their drug candidate RCD405 is designed to not only relieve symptoms but also address the underlying causes of COPD.

RCD405 distinguishes itself from existing treatment by a combined mechanism of action, which both widens the airways and reduces inflammation. Arcede Pharma hopes that this will lead to a more effective treatment for COPD patients, and at the same time provide a more favourable side effect profile than today’s treatment regimens.

Sees great market potential

With RCD405, the company is targeting one of the largest pharmaceutical markets. In an attempt to estimate the potential, an analysis was recently carried out based on two different scenarios for the drug candidate. In the first scenario, RCD405 is used as a combination treatment together with already established COPD drugs. Here, the company sees potential annual sales of approximately 2 billion EUR in the US and the four largest countries in Europe.

In the next scenario, RCD405 is seen as a first-in-class treatment with disease-modifying properties. In that scenario, according to the company, sales could amount to over 16 billion EUR annually.

Tox program complete

This autumn, the company took the last major preclinical step with the candidate, completing the toxicology program. From a purely regulatory point of view, the door is thus open to take the next step in the development, clinical phase I studies. The project is backed by promising preclinical data, but it is only now that we can get an indication of how RCD405 will work in humans.

Preparations are ongoing

However, before dosing the first participant, the company needs to make some preparations. The most important thing is to find the right dose and concentration, to ensure that you get a good effect in humans, without compromising on safety.

Arcede Pharma is working together with two research groups at Lund University and Karolinska Institutet, who have also continued to study the candidate’s effect. In the studies, it has been shown that RCD405 acts as both a relaxant and an anti-inflammatory agent in two different disease models for airway inflammation.

This is data that they hope to present in one of the scientific journals that cover the area. In addition to academic collaborations, Arcede Pharma also works with the inhaler company Iconovo, which is responsible for the formulation of the drug.

If the work goes according to plan, the project is expected to be able to enter the clinic in the latter half of 2024.

TO1 will finance the preparations for the clinic

To finance the preparations for the clinical development stage, the company is currently exercising the warrant TO1, which was issued in connection with this summer’s rights issue. Arcede then received a contribution of 9.2 million SEK and if TO1 is fully utilized, the company will receive an injection of an additional approximately SEK 10 million, before fees and issue costs. The subscription price in TO1 is set at SEK 0.09 per share, which is approximately what the Arcede share is trading at, at the time of writing.

Comments from the Chairman of the Board

In connection with the capital raise, BioStock contacted Arcede Pharma’s Chairman of the Board, Ingemar Kihlström, to find out more about the development.

Ingemar Kihlström, chariman Arcede Pharma
Ingemar Kihlström, chariman Arcede Pharma

There are many established treatments for COPD and asthma, how do you plan to position yourself in the market?

– As we have a new mechanism of action and a dual effect, we hope that this is a treatment that can be started at a much earlier stage of the disease and thus prevent the disease from getting worse. In doing so, we are targeting not only those who are already receiving treatment, but also those who have not previously been treated because they are at an earlier stage of the disease.

You recently carried out an analysis of the market potential of RCD405. Can you tell us a little more about the two scenarios you developed and how you calculated to arrive at the potential in each scenario?

– In collaboration with experienced consultants in the field, we have developed these two scenarios. They have taken into account the total proportion of the population with COPD in each country included in the analysis and then looked at how many of these patients would be eligible for the different types of treatment.

– They then estimated the percentage of those who would be prescribed the treatment based on estimates from similar types of drugs for asthma, COPD but also other inflammatory diseases.

– It is thus a fairly complex analysis with several variables, which of course may change the more we understand about the exact mechanism of action.

You recently announced that CEO Mia Lundblad has chosen to move on to a position outside the company. How is the search for a new permanent CEO going?

– The recruitment process for a new CEO has already been initiated through a recruitment firm.

In the meantime, you will step in as Executive Chairman of the Board, while your CFO Erik Magnusson will become acting CEO. How have you divided the responsibilities between you?

– The Board of Directors has decided that Erik will be acting from 1 February with full responsibility for the day-to-day operational work. As I have extensive experience of the project from my time at Respiratorius, my task will be to support him in R&D issues and long-term strategic tasks.

We are currently in the exercise period of your TO1 warrants. How will the money be used?

– Upon full subscription of the warrants, the company can receive approximately 10 MSEK, before issue costs. This injection will help us prepare for phase I, including the completion of the formulation activities and the start of substance production.

What do you think makes Arcede an attractive investment right now?

– The most important thing is to carry out as many planned activities as possible before the start of phase I to reduce the risk of delays and to start the first clinical study already next winter.

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.

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