Final Report from Phase 1b PK/PD study
Evgen Pharma plc
("Evgen" or "the Company" or "the Group")
Final Clinical Study Report from Phase 1b PK/PD study of new SFX-01 tablet formulation approved
New formulation of SFX-01 performs as designed, delivers meaningful levels of drug and metabolites, is safe and well tolerated
Results to be shared with Evgen Partner, Stalicla in support of regulatory
submissions for Phase 2 studies in Autism Spectrum Disorder
Alderley Park, UK - 15 August 2023: Evgen Pharma plc (AIM: EVG), a clinical stage drug development company developing sulforaphane-based medicines, reports the final data from its Phase 1b healthy volunteer study using the Company's new enteric coated tablet formation of lead asset SFX-01. The data are contained in the extensive Clinical Study Report (CSR) which has been approved by the Company and its providers in compliance with good clinical practice (GCP).
Following the top-level data announced in March 2023, the full pre-specified pharmacokinetic (PK) and pharmacodynamic (PD)* dataset from the placebo-controlled, dose-escalating, randomised study has now been analysed and reported in the approved CSR. The study aimed to investigate how sulforaphane released from the new enteric-coated tablet formulation was absorbed from the intestine and its effects on the physiology of healthy volunteers.
· As reported in March 2023, based on the time course seen, sulforaphane was released by the new enteric coated tablet beyond the acid environment of the stomach
· No serious adverse events were observed
· Total blood levels of sulforaphane (SFN) and SFN-metabolites were confirmed in the micromolar range, where efficacy is seen in vitro
· Additional pharmacodynamic exploratory investigation, utilising mRNA sequencing, showed changes in gene expression after dosing with SFX-01 even in healthy volunteers
In addition to the biomarkers analysed in the study and contained within the CSR, changes in gene expression were measured by mRNA sequencing on participants' blood, for placebo and SFX-01 treated subjects that received 600mg once daily. The initial analysis identified a large number of significant differentially expressed genes in the SFX-01 treated group, between blood samples taken before the first dose was administered (baseline) and blood samples taken after the first dose timepoint (6 hours after first dose). Further analysis will be undertaken on this large and complex dataset to gain insight into the particular genes identified. Further disease-related mechanistic insight will also be provided from future clinical studies in patients.
Dr Huw Jones, Evgen CEO said:
"The final CSR confirms, as expected, that the new formulation of SFX-01 is safe and well tolerated at multiple doses. It delivers the drug at highly relevant blood levels within the timeframes expected of an enteric coated formulation.
"We are sharing this report with our partner Stalicla SA as part of our collaboration and will be working with them on supporting regulatory submissions for Phase 2 trials in Autism Spectrum Disorder (ASD).
"With this study, we have conducted the most extensive evaluation of sulforaphane and its metabolites in man ever produced in a single study and have done this to a drug regulatory standard, consistent with our business model."
Dr Glen Clack, Evgen CMO added:
"The pharmacodynamic data generate a number of hypotheses relevant in both oncology and other conditions that we continue to explore. These insights will be used in our grant-funded collaborations with the Erasmus Medical Centre in Rotterdam in glioblastoma and with our partner, Stalicla, in ASD.
"We are very pleased with the results and are eager to move forward to applying the new formulation to future clinical studies using SFX-01."
Following the successful completion of this study, all further regulatory submissions and clinical trials will be conducted using the new tablet formulation of SFX-01. The new form brings additional patent protection and replaces the previous prototype capsule formulation.
*A pharmacokinetic study looks at how the drug is absorbed and circulates in the body, while a pharmacodynamic study investigates how the drug exerts its effects in the body including the biochemical, molecular and physiological mechanisms relevant to disease.
Evgen Pharma PLC
Dr Huw Jones, CEO
+44 1625 466591
FinnCap (Nominated Advisor and Broker)
+44 20 7220 0500
Melanie Toyne-Sewell / Rozi Morris/ Adam Loudon
+44 207 457 2020
Notes to Editors
Evgen's core technology is Sulforadex®, a method for synthesising and stabilising sulforaphane and novel proprietary analogues based on sulforaphane. Sulforaphanes have shown potential benefits in neurodevelopmental disorders, oncology and inflammatory conditions. SFX-01, Evgen's lead asset, is the only stabilised sulforaphane suitable for clinical research and eventual approval as a medicine.
SFX-01 is a patented composition of synthetic sulforaphane and alpha-cyclodextrin. The Company has already completed three trials in patients, including a positive open label trial in metastatic breast cancer using the prototype capsule formulation.
About Evgen Pharma plc
Evgen Pharma is a clinical stage drug development company developing sulforaphane based medicines for the treatment of multiple diseases. The Company's core technology is Sulforadex®, a method for synthesising and stabilising the highly biologically active compound sulforaphane and novel proprietary analogues based on sulforaphane.
The Company's lead asset, SFX-01, is a patented composition of synthetic sulforaphane and alpha-cyclodextrin and has undergone clinical trials for oestrogen-positive (ER+) metastatic breast cancer and recently a Phase 1b study of the Company's new enteric coated tablet formulation. The FDA has granted Orphan Drug status to SFX-01 in malignant glioma. SFX-01 will be investigated initially in this indication as an investigator sponsored study in the Netherlands.
The Company also has a wide number of collaborations with leading academic centres in the UK, Europe and the US as part of the continuing strategy to build the scientific data for the compound. Recently, Evgen completed an out-licensing transaction with Stalicla SA, a Swiss specialist company in neurodevelopmental disorders, commencing with autism spectrum disorder. The deal, if successful, will generate milestone payments of $160.5m and a double-digit royalty on sales.
The Company has its headquarters and registered office at Alderley Park, Cheshire. It is listed on AIM in London and trades under the ticker symbol EVG.
For further information, please visit: www.evgen.com.