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- Dimerix (DXB) pauses recruitment of COVID-19 patients with COVID-19 for its clinical study after safety issues were observed in patients with severe COVID-19
- The Independent Data Safety Monitoring Board’s (DSMB) scheduled interim safety assessment flagged the safety signal related to the use of angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARB) in patients with severe COVID-19
- The company says safety concerns were not found in patients with moderate COVID-19
- Assessment of the data from patients with severe COVID-19 will be undertaken and reported as soon as available
- DXB shares fall 18.2 per cent to 18 cents
Dimerix (DXB) has paused recruitment of patients with COVID-19 for its clinical study while safety concerns are investigated.
The Independent Data Safety Monitoring Board (DSMB) conducted a scheduled interim safety assessment on available data to check whether the treatments in the REMAP-CAP ACE2 renin angiotensin system (RAS) study domain were safe in patients with both severe and moderate COVID-19.
Dimerix said the DSMB communicated safety concerns related to the use of angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARB) in patients with severe COVID-19.
The DSMB recommended the recruitment of patients with severe COVID-19 be suspended.
Dimerix said the REMAP-CAP trial will also temporarily pause enrolment of patients with moderate COVID-19 to allow review of additional data prior to potentially resuming enrolment.
Assessment of the data from patients with severe COVID-19 will be undertaken and reported as soon as available, the company said.
A total of 779 patients with severe and moderate COVID-19 were recruited for the RAS modulation study.
The study randomised patients to receive either an angiotensin receptor (ARB) block alone, angiotensin converting enzyme (ACE) inhibitor alone, ARB simultaneously with DMX-200 or no RAS inhibitor.
DSMB flagged a concerning safety signal was observed in patients with severe COVID-19 who received an ACE inhibitor or ARB.
The safety concerns were not observed in patients with moderate COVID-19, Dimerix said.
DXB shares were trading 18.2 per cent lower at 18 cents at 11:34 am AEDT.
