Evgen starts recruiting volunteers for trial of lead asset
Clinical-stage drug development company Evgen Pharma announced the start of recruitment for the pharmacokinetic and pharmacodynamic trial in healthy volunteers, and the decision to commence an investigator-sponsored clinical study for the glioblastoma programme on Wednesday.
The AIM-traded firm said the purpose of the human volunteer study was to examine the performance of its new enteric-coated tablet formulation of lead asset ‘SFX-01’.
Following the regulatory approval announced on 3 October, the study was now open for recruitment, and the first subjects were expected to enter the trial on schedule this week.
The board said the trial was a placebo-controlled, dose-escalating, randomised trial that would assess how SFX-01 in its new form and formulation is absorbed and circulates in the body, and how it engages with target molecules.
Results of the human volunteer study were expected during the first half of 2023.
In glioblastoma, Evgen said it had been consulting “widely” with world-renowned experts in the treatment of brain cancers with regards to the planned study.
It said the key opinion leaders advised that further preclinical work and an early-stage clinical trial of SFX-01 in patients with glioblastoma should be conducted, to acquire more clarity on sulforaphane entering the brain tumour and its interaction with molecular targets in the tumour tissue of GBM patients.
The company said it expected the approach would further de-risk the phase two clinical trial.
Supporting an investigator-sponsored study in glioblastoma for the first clinical phase would result in the company having financial resources for a further year - at least to the end of the fourth quarter of 2024.
Evgen said the runway would extend “well into 2025” if further milestones relating to the results from the human volunteer study and FDA Investigational New Drug approval were received following the Stalicla licensing transaction announced earlier in the week.
“We expect to have a very complete set of data regarding the performance of the new formulation of SFX-01 by the first half of 2023, as planned,” said chief executive officer Dr Huw Jones.
“This will generate more insight than ever into the way SFX-01 is handled in the bloodstream and how it interacts with the key molecular targets of interest in a wide range of diseases.
“We already have promising preclinical data in glioblastoma as well as orphan disease status which we announced last year.”
Dr Jones said given the complexity of the disease, and the time and cost going into clinical studies, the firm wanted to de-risk the programme as much as possible.
“Under advice from experts, we believe a stronger understanding of the potential direct impacts of SFX-01 in the brain tumour tissue itself will enable us to improve the trial design further and enhance the prospects of success.
“In the meantime, we are also focussing on our new and significant partnership with Stalicla and are driving our breast cancer programme forward in collaboration with the Manchester Breast Centre.
“We continue to explore partnering opportunities in the context of a considerably longer cash runway, with the prospect of significant further non-dilutive cash inflows from our partners.”
At 1228 BST, shares in Evgen Pharma were up 9.73% at 6.2p.
Reporting by Josh White at Sharecast.com.