(Alliance News) - Evgen Pharma PLC on Tuesday said final data from a trial of its SFX-01 therapy has shown a new formulation of the drug is safe.
The Cheshire, England-based clinical stage drug development company focused on developing sulforaphane-based medicines said the data showed that the new SFX-01 forumlation performed "as designed, delivers meaningful levels of drug and metabolites, is safe and well tolerated".
Evgen said no serious adverse events were seen in the trial, noting that analysis showed a number of differently expressed genes in the group treated with SFX-01, even in healthy patients.
The trial is aimed at identifying how sulforaphane from its new enteric-coated tablet formulation was absorbed in the intestine,, as well as its effects on healthy volunteers, Evgen said.
Evgen said further analysis will be conducted.
Chief Executive Huw Jones 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."
Chief Medical Officer Glen Clack 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."
Evgen shares rose 4.8% to 2.52 pence each on Tuesday morning in London.
By Harvey Dorset, Alliance News reporter
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