Guard Therapeutics International AB: Guard Therapeutics announces positive top line results from a clinical phase 1a study of ROSgard

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 ROSgardTM 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). 
 
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: [phone] 
 
E-mail: [e-mail] 
 
About Guard Therapeutics 
Guard Therapeutics' investigational drug ROSgardTM 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. [phone], [e-mail]. 
 
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. 
 
Document: https://eqs-cockpit.com/c/fncls.ssp?u=HGCOGDEFJW [1] 
Document title: Top-Line Results SAD Study 17 March 2020 
Language:    English 
Company:     Guard Therapeutics International AB 
             Scheelevägen 22 
             223 63 Lund 
             Sweden 
Phone:       [phone] 
E-mail:      [e-mail] 
Internet:    www.guardtherapeutics.com 
ISIN:        SE0009973357 
EQS News ID: 998447 
 
Guard Therapeutics International AB / 108 Company Announcement 
 
Dissemination of a Swedish Financial News, transmitted by EQS Group. 
The issuer is solely responsible for the content of this announcement. 
 
End of Announcement EQS News Service 
 
998447 2020-03-17 
 
 
1: https://eqs-cockpit.com/cgi-bin/fncls.ssp?fn=redirect&url=8c2beecee65a6ecd26af0dc81d92bcc9&application_id=998447&site_id=vwd&application_name=news 
 

(END) Dow Jones Newswires

March 17, 2020 05:00 ET (09:00 GMT)