Evgen Pharma PLC (AIM:EVG) said it made headway with regulators on both sides of the Atlantic, paving the way for clinical progress in 2022.
Here in the UK, it met with the Medicines and Healthcare products Regulatory Agency (MHRA) to discuss protocols for a phase I study of the new tablet form of SFX-01, its lead asset.
Approval for the evaluation, which will assess safety, tolerability and the way the drug interacts with the body, is expected this month.
Researchers will also take the opportunity to generate data on dose escalation and target pathway engagement.
In the US, the company will submit a ‘package’ of information ahead of a meeting with the Food & Drug Administration.
Evgen wants to secure investigational new drug meeting status for SFX-01 so it can carry out a phase I/II study in people with glioblastoma, a type of brain tumour with a very poor prognosis.
Work is expected to start later this year at sites in the UK and Mainland Europe. The trial can be extended to the US if the data are ‘supportive’, the company said.
The new tablet form of SFX-01 is ready for use in both clinical groups.
Evgen chief executive, Dr Huw Jones, said: "I am delighted with the positive progress that has been made with MHRA and FDA regarding our two planned clinical trials for SFX-01, both of which we intend to commence later this year.
“We look forward to updating the market in due course regarding further progress with these key regulatory authorities and with regard to these two important trials."