Dimerix stays on track for a big year in 2020 as market volatility spikes
Health & Biotech
Health & Biotech
Link copied to
Special Report: The company has set up strong contingency plans and remains on schedule with two exciting Phase II clinical trials.
For biotech company Dimerix (ASX:DXB), the early part of this year has been all about staying calm amid the storm on global markets.
The company has been busy executing on advanced clinical trials for two separate kidney treatments, which are both moving toward completion by the middle of the year.
Dimerix has two patented products – DMX-200, used in the treatment of diabetic kidney disease, and a separate treatment for focal segmental glomerulosclerosis (FSGS), or scarring of the kidney.
And amid the global volatility going on around it, Dimerix CEO Dr Nina Webster released a newsletter for investors this week to provide an update on the latest developments.
But there was plenty of good news for investors, starting with a new round of initiated coverage with investment fund Argonaut Securities, which published an indicative price target of 40 cents per share – a 275 per cent premium to the current trading price.
The company also noticed that while broader investment liquidity has dried up, trading volumes in DXB have remained elevated – a strong indication of continued investor interest.
Throughout the clinical testing process, Dimerix has worked closely with global health authorities, who are taking the technology seriously.
As an example, last year the company’s FSGS treatment met the criteria to be approved for accelerated approval by US regulators. And multiple Australia patients who were tested in Phase 2a trials for DMX-200, as well as patients completing the two current studies, have continued on the medication via the compassionate-use Special Access Scheme (SAS), as approved by the Therapeutic Goods Association (TGA).
It all adds up to an exciting few months before the Phase II results are completed, with final patient doses scheduled for June (FSGS) and July (DMX-200).
And as the coronavirus crisis swirls around it, the company has moved to set up contingency plans in the event of an unexpected impact. Most importantly, it’s previously added another five patients to its DMX-200 study which brings the total to 45. That’s now well above the minimum of 40 required for statistical viability, and provides a margin of safety around the testing process.
The company also has the capacity for flexibility in the testing cohort of its FSGS treatment, which is designed to derive maximum insights from a smaller patient sample size.
Looking ahead, Dimerix has laid the groundwork for a rapid scaleup in the event of successful clinical trial results.
Along with its contract manufacturer – which is approved by the US Food & Drug Administration – the company remains on track to meet Good Manufacturing Practice (GMP) regulations for commercial production.
By getting GMP commercial scale production at this stage of development, the company is getting a step ahead of the game to meet the two-year testing requirement. If trials are successful, that will pay huge dividends.
The level of execution evident means that while Dimerix is moving towards its all-important clinical trials, this isn’t just any biotechnology company.
Led by Webster, the executive team has a strong framework in place covering regulation and commercialisation, which leave it well-placed to outperform in the leadup to mid-year results.