Press release from Companies

Published: 2023-07-06 21:00:00

WntResearch AB: NeoFox revised study plan approved

The Spanish regulatory authorities have approved the revised study plan for the phase 2 NeoFox study for the drug candidate Foxy-5.

Due to the reported unexpectedly rapid positive observations with Foxy-5, the study plan for the phase 2 NeoFox study has been revised. The change is now approved by both The Spanish Agency for Medicines and Medical Devices and the Central Ethical Review Committee in Spain, where the majority of the participating clinics are located.

The change means that new end points will be introduced at the patients' surgery, to show the effects previously observed in an ad hoc analysis. Patients have been treated for three weeks from diagnosis to surgery. Due to Foxy-5's favourable safety profile, and to demonstrate Foxy-5's maximum potential in this patient group, the study will also investigate whether Foxy-5 can be given at higher doses.

The original study was to evaluate the effect of Foxy-5 two years after surgery, but this will not be done. This means that the original aim of the study will not be achieved, i.e. to show the presence of daughter tumours and overall survival measured by the ctDNA marker. The data available so far on the patients included and now to be terminated do not show any such effect. The new end point parameters are measured at surgery and will therefore measure Foxy-5's effect directly on the tumour. It also means that patients are in the study two years shorter, which reduces the cost per patient, and that the study is easier to conduct.

A first patient is expected to be included according to the new study design after the August holiday period in Spain, i.e. in early September. Spain is the most important country for this study and therefore Hungary comes later in the process.

"This is fantastic news for us and for a potential new treatment for patients affected by colon cancer. It is gratifying to also be able to increase the dose as it is now that we have a good opportunity to do so. We must remember that there are many drug candidates in development, so we ought to always take all opportunities to optimise the development. I will come back with further details about the new study design and time aspects", says Pernilla Sandwall, CEO.

For further information:

Pernilla Sandwall, VD

WntResearch AB is obliged to publish this information in accordance with the EU Market Abuse Regulation. This information was submitted for publication, through the agency of the contact person set out above, on July 6, 2023.

About Wntresearch AB 

WntResearch is developing a completely new type of cancer drug that inhibits the ability of tumour cells to spread in the body and form metastases. The company's research is focused on studying the endogenous protein WNT5A, which in scientific studies has shown to affect tumour cells' ability to move and spread in the body. WntResearch drug candidate Foxy-5 is a peptide that mimics the function of WNT5A and is intended to reduce the mobility and spread of cancer cells thus preventing metastases from occurring. Although current cancer treatment has become more effective, there are no effective ways to prevent the onset of metastases that cause about 90 per cent of all cancer-related deaths. Foxy-5 has a unique mechanism of action and has shown a good safety profile with few side effects in two Phase I clinical trials. The safety and efficacy of Foxy-5 are now being evaluated in the ongoing Phase 2 clinical trial NeoFox, in patients with stage II-III colon cancer.

WntResearch is listed on the Spotlight Stock Market. For more information, please visit: Follow WntResearch on Linked in 

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