Institutions back hotshot Dimerix for COVID-19 study
Health & Biotech
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Special Report: Biotech Dimerix wins over institutional investors as it prepares for a global Phase 3 COVID-19 trial.
Hotshot biotech Dimerix (ASX:DXB) is finally on the radar of institutional investors, who bought in for the first time via a $5.8m capital raising that will help fund a brand-new COVID-19 project.
Dimerix chief and managing director Dr Nina Webster says having institutions on the register is a sign the market believes the company is becoming a serious contender.
“Dimerix has always said it has sufficient funds for the current Phase 2 studies into diabetic kidney disease and focal segmental glomerulosclerosis (FSGS), and that remains true,” she said.
“But the global study by REMAP-CAP in acute respiratory distress syndrome (ARDS) is a completely separate opportunity, and this will be funded separately.”
The funding will be used to ramp up manufacturing of Dimerix’s main drug candidate DMX-200, which is being tested in the upcoming Phase 2 trials as well as included in the REMAP-CAP globe pivotal study, as well as resourcing to deliver on the opportunity.
A pivotal study is typically a Phase III clinical trial — the last needed before a drug can be registered and sold — which confirms safety and efficacy across a large group of patients.
The Randomised, Embedded, Multifactorial Adaptive Platform trial for Community-Acquired Pneumonia (REMAP-CAP) program endorsed by the World Health Organisation (WHO) will look at whether DMX-200 can reduce the inflammatory response in the lungs caused by ARDS and thereby reduce inflammation and subsequent scarring.
DMX-200 was chosen for the global study protocol at the start of June and while it is fully funded by the organisations running the trial, it does mean Dimerix may need to quickly supply and distribute a significant amount of its drug to over 200 sites in 16 different countries, quickly.
It also means that manufacturing slots need to be booked and committed to now at manufacturing companies for production later in the year.
The company is still looking for non-dilutive grant and philanthropic funding, but this was an opportunity to sate interest from the first institutions to consider Dimerix, as well as provide a strong financial position entering into clinical study results and potential partnering discussions.
Dimerix’s share price has run from 11c in December last year to a 52-week high of 59.5c on the back of speculation on good results in July from the FSGS study, and the diabetic kidney disease study after that.
Patients and physicians in both studies have asked, and been given permission by the TGA, to remain on DMX-200 after they end, which Webster is “encouraged” by.
“Having this extra cash runway means we can continue to plan for success over the long term, in parallel to having licensing discussions from a position of strength,” Webster said.
“We have multiple products in the pipeline now at end of Phase 2 and Phase 3 levels, and DMX-700 under going proof-of-concept studies for chronic obstructive pulmonary disease (COPD), the fourth-leading cause of death in the world. As such, we are well positioned to deliver on a number of value driving events in the near term”.
Listen now to the HealthKick Podcast on Dimerix: