Guard Therapeutics today announced positive top line results from the final and highest dosage group as part of a clinical phase 1a study where single ascending doses (SAD) of the investigational drug ROSgard™ were administered to healthy subjects. ROSgard also demonstrated good pharmacokinetic properties and a favourable safety profile at this dosage level, which is higher than the one that is expected to be used in future patient studies. The next stage in the phase 1a programme is to study ROSgard in multiple ascending doses (MAD).
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With what is called the SAD part of the clinical phase 1a study now successfully concluded, Guard Therapeutics will apply to commence dosage of ROSgard in multiple ascending doses (MAD) in healthy subjects, based on an existing conditional approval from the Swedish Medical Products Agency. The company is anticipating that it will be possible to conclude the remaining part of the phase 1a programme during summer 2020. In parallel with this, a separate phase 1 study is underway to document the investigational drug’s pharmacokinetics in individuals with reduced kidney function who have not started dialysis treatment.
”The fact that we have now also been able to generate positive study results for ROSgard at a dosage level that is higher than that which is expected to be used in patient studies, further strengthens the investigational drug’s profile in advance of its continued development”, says Tobias Agervald, CEO of Guard Therapeutics.
As previously announced, Guard Therapeutics expects to be able to conduct its first small-scale study as early as 2020 in patients who will be undergoing cardiac surgery.
For further information, please Contact:
Tobias Agervald, CEO
Telephone: +46 (0)46-286 50 30
E-mail: tobias.agervald@guardtherapeutics.com
About Guard Therapeutics
Guard Therapeutics’ investigational drug ROSgard™ has been documented in several pre-clinical studies to protect against cell and organ damage, including acute kidney damage, by counteracting oxidative stress and supporting regenerative processes. Guard Therapeutics is listed on Nasdaq First North Growth Market Stockholm. Certified Adviser is Erik Penser Bank AB, tel. +46 (0)8-463 83 00, certifiedadviser@penser.se.
This constitutes information that Guard Therapeutics International AB (publ) is required to publish under the EU’s Market Abuse Regulation. The information was submitted through the above contact for publication on 17 March 2020 at 10.00.