- Dimerix (DXB) formally closes recruitment of moderate state COVID-19 patients for REMAP-CAP’s renin angiotensin system (RAS) domain clinical study
- This is to allow for the full results of this domain to be analysed and reported, which includes the analysis of the company’s proprietary drug DMX-200
- Dimerix insists the decision isn’t based on any further safety concerns but reflects the REMAP-CAP International Steering Committee’s belief that continued recruitment would be challenging, citing decreasing hospitalisation rates as one of the challenges
- The results of this study will be analysed by the REMAP-CAP team and prepared for publication
- Shares in Dimerix hold steady at 12.5 cents as of 11:44 am AEST
Dimerix (DXB) has formally closed recruitment of moderate state COVID-19 patients for REMAP-CAP’s renin angiotensin system (RAS) domain clinical study, including DMX-200.
This move will reportedly allow for the full results of this domain to be analysed and reported.
Recruitment of critically ill patients to the trial was closed in February 2022, and recruitment of non-critically ill patients was paused pending further analysis of study safety data.
The biopharmaceutical company insisted the study closure is not based on any further safety concerns but is instead, a pragmatic decision reflecting the REMAP-CAP International Steering Committee’s belief that continued recruitment would be challenging.
Globally decreasing hospitalisation rates of COVID-19 patients appropriate for the study is one of the challenges cited by the company.
The results of this study will be analysed by the REMAP-CAP team and prepared for publication.
The Independent Data Safety Monitoring Board (DSMB) had conducted a scheduled interim safety assessment on available data to check whether the treatments in the 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.
Currently, the company is developing its proprietary product DMX-200 for focal segmental glomerulosclerosis (FSGS), respiratory complications associated with COVID-19 and diabetic kidney disease.
DMX-200 is protected by granted patents in various territories until 2032, with patent applications submitted globally that may extend patent protection to 2042.
The proprietary drug is also under investigation as a potential treatment for acute respiratory distress syndrome (ARDS) in COVID-19 patients.
Shares in Dimerix held steady at 12.5 cents as of 11:44 am AEST.