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Wnt follows the authorities’ advice and pauses recruitment to phase II study

Wnt follows the authorities’ advice and pauses recruitment to phase II study

5 July, 2021

Monday saw the news that biotech WntResearch has decided to pause the recruitment of patients to its phase II study in Spain and Hungary. The reason is the ongoing Covid-19 pandemic, which places a heavy burden on the healthcare system of both those countries. Therefore, in accordance with the advice of the national authorities, the company has chosen to suspend patient recruitment activities in order not to add to the burden placed on the participating clinics or jeopardise the study’s integrity. BioStock had the chance to ask a couple of questions of CEO Peter Morsing about the decision.

WntResearch’s candidate Foxy-5 is being developed to inhibit the spread of cancer metastases, the main cause of cancer-related deaths. Today, there are no effective treatments that can reduce the risk of metastases, but through Foxy-5 – a synthetic copy of a specific part of the WNT5A protein that is strongly linked to the risk of metastases – WntResearch hopes to be able to offer such a treatment.

By adding Foxy-5, the aim is to reduce the ability of cancer cells to break away from the primary tumour, thus reducing the risk of metastases.

Suspending recruitment to phase II-study

At the beginning of the week, the Malmö company became the latest in a list companies to announce that they too had made the decision to suspend recruitment to its ongoing clinical trial due to Covid-19. The phase II study Neofox, which examines Foxy-5’s capacity to reduce the risk of metastases and relapse in patients with colon cancer, is currently being carried out at 17 clinics in Spain and 12 in Hungary.

The decision is in line with the advice issued by the national health authorities aimed at freeing up health care resources to combat the coronavirus outbreak.

However, it should be noted that this decision does not mean that all work with the study is suspended. The study is divided into an active phase during which the patients receive Foxy-5 three times a week during a maximum of three months. Then comes a follow-up phase where tests are run every third month. This work continues and is less sensitive to whether or not the tests are run at the time points stated in the protocol. All tests are sent to WntResearch, and when enough material has been gathered, the analyses on patients in the risk group will be carried out.

A difficult situation for healthcare systems

WntResearch has had, and continues to have, a close dialogue about the situation with the relevant hospitals and the clinical trial leaders. Together, they have now made the decision to pause the patient recruitment to the study as it is difficult to conduct a clinical trial in the current climate, especially considering the difficult situation faced by the healthcare systems in the two countries where the study is being conducted. The situation is particularly serious in Spain, one of the countries most affected by the ongoing pandemic, and the company has made the judgement that continuing the study would jeopardise both the patients’ health and the integrity of the study itself. The situation in Hungary is also uncertain and the country’s healthcare resources are needed to help Covid-19 patients.

So far, more than 40 patients have been included in Spain, 20 as a control and 20 treated with Foxy-5. Further patients undergoing treatment will be offered the chance to complete that treatment before patient recruitment is suspended. The company’s goal is to resume the study as soon as the healthcare situation allows it, but according to the company it is not reasonable now to speculate as to when this might happen.

BioStock had the opportunity to ask WntResearch’s CEO Peter Morsing a few questions about the decision to pause the recruitment to the study.

First and foremost, the pause of patient recruitment is of course not an easy decision. Can you tell us a bit more about what you have based this decision on?

Peter Morsing, CEO, WntResearch

– Not only is the situation in the hospitals extremely strained due to Covid-19, but, in addition to this, our study is based on patients visiting the hospitals to receive treatment several times a week. Patients are now worried about being infected whilst traveling, and, at the same time, there is a wish to limit the number of individuals who visit the hospitals.

– All in all, this creates a situation in which it is difficult to conduct clinical trials right now. It is not an easy decision, but the moral and ethical aspects of this situation are substantial, and this decision is also in agreement with the recommendations of the authorities.

– Only two out of the six patients in the active treatment phase have chosen not to complete the study, but none of the individuals in the considerably larger follow-up group have decided to leave the study.

The aim is of course to resume the study as soon as the situation allows for that. Does the pause mean that you have to fulfil any further requirements from the authorities in order to start the study back up?

– The study will start back up again without delay as soon as the healthcare situation permits it, and there are no further regulatory requirements. In Spain, the study was on full steam ahead before this break, and in Hungary everything was ready for the treatment of the first patient. During the pause, we will complete the final contracts in Hungary to ensure that we can start back up quickly.

 So far you have initiated treatment in 40 patients. How many patients is the study to include in total?

– We have included more than 40 patients in the study, half of whom have received Foxy-5. However, all these patients do not meet the predetermined criteria for the statistical evaluation, i.e. in the pathological assessment after surgery, they have a low risk of relapse. These patients should not, according to the study protocol, be included as they make it more difficult to detect an effect of Foxy-5 because they historically do not have an increased risk of relapse.

– The study should include 30 evaluable patients in each study arm. To achieve this, we need about 100 more patients until we reach full recruitment.

 Can you tell us anything about how the paused study and Covid-19 effects the company’s financial situation?

– There will be a month of slowing down and finally stopping activities. After that the cost during the remaining pause will be down to a third of the cost when we conduct full activities.

 Do you have a plan for how to handle this?

– We plan for one of month of reducing activities, a two-month break and then we will take it month-by-month to see when the situation at the hospitals has stabilised before we activate the study again. We hope this will happen in after summer. I also want to point out that in the worst-case scenario, we can skip a test completely and perform it three months later without this effecting the outcome of the study.

– Our assessment is that it will take some time before the healthcare system and society in general has recovered after this crisis.

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.w

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