Safety study initiated with FG001
January 9, 2020
FluoGuide’s FG001 is designed to be well tolerated and its two main components have both demonstrated excellent tolerability profiles in humans.
The result of the species qualification points FluoGuide to use the species with the longest delivery time and the first results from the clinical study with FG001 in patients with glioblastoma will therefore be presented in Q3 2020 instead of Q2 2020. Despite a temporal shift of one quarter, no other milestones or budget are affected.
The safety of FG001 is to be established in non-clinical toxicity studies to the satisfaction of both FluoGuide and health authorities before it can be tested in humans. uPAR differs between humans and the animal species normally used in safety studies. This species difference in uPAR binding is important to understand and take into consideration when interpreting the findings, or lack of findings, in non-clinical toxicity studies before setting the first human dose.
FluoGuide has chosen to conduct an in debts investigation of these differences in uPAR binding for a number of reasons: (1) to reduce risk for patients when testing FG001 first-in-humans, (2) to reduce the risk of delays of commercial milestones by having to re-do the in vivo safety studies at a later stage where a repetition of the in vivo safety studies could have caused significant delays and additional costs, and (3) the set-up of uPAR binding assays can significantly accelerate FluoGuide’s pipeline of uPAR targeted fluorophores.
Morten Albrechtsen, CEO comments:
“We are delighted that the safety study is now initiated and look forward to an exciting 2020. We would of course have preferred to deliver the first result from the clinical study in Q2 2020 but prefer to temporal shift three months now to minimise risk of a delay at a later stage that could have seriously affected our commercial milestones and budget”.
FluoGuide A/S is obliged to publish this information in accordance with the EU Market Abuse Regulation. The information was provided by the contact person above for publication on the 9th of January 2020.