After receiving the green light for its redesigned study plan for NeoFox this summer, WntResearch have announced the recruitment of the first patient. The revised study is now officially underway with the first part expected to take about six months to complete. BioStock contacted CEO Pernilla Sandwall for a comment on this milestone.
WntResearch’s drug development is based on the endogenous protein WNT5A, which has been shown to play an important role in the mobility and spread of tumour cells. Foxy-5, which is the company’s lead drug candidate, is a peptide aimed at mimicking the function of WNT5A. The goal is to prevent the motility of cancer cells, thereby reducing the risk of metastases, which account for almost 90 per cent of all cancer-related deaths.
New study plan opens for shorter and more cost-efficient study
Last year, the company announced its intention to make certain changes to the study plan for the phase II study, NeoFox, after observing early and positive clinical effects of Foxy-5 in colon cancer patients. Instead of treating patients both before and after surgergical removal of the primary tumour until chemotherapy is initiated, patients will now be treated with Foxy-5 for at least three weeks until surgery and not afterwards. The efficacy parameters will be measured at the time of surgery, and patients will be followed up for two years.
This amendment, which was approved by both the Spanish Medicines Agency and the Central Ethical Review Committee, significantly shortens the study. This, in turn, means that it is not nearly as expensive to implement as originally planned.
First patient recruited
After being given the green light by the authorities this summer, the first patient has now been recruited to NeoFox at a trial centre in Barcelona. According to the new study design, the continuation will be carried out in two parts. Based on the positive safety profile of Foxy-5, the first step will be to evaluate higher doses than before, in order to fully understand the efficacy of the drug. This part of the study is being conducted exclusively in Spain and will take about six months, according to the company.
After finding the right dose, the second part will begin, where approximately 80 patients will be treated with the dose that is considered optimal. This part of the study will focus on evaluating the effects of Foxy-5 and will also include patients in Hungary. At the time of writing, WntResearch expects to be able to release top-line data sometime in 2025.
“This is great and important! After receiving approval from the relevant authorities for the revised study plan for NeoFox during the summer, we are very enthusiastic now that the first patient has been recruited. The redesigned study gives Foxy-5 the best opportunities to show its potential and it also provides great benefits in terms of time and cost savings compared to the original plan,” WntResearch’s CEO Pernilla Sandwall states in a comment to BioStock.