Dimerix - Interim Data Assessment in Mid-March

Over the last two months, there have been some strong price movements in several major and minor biotech stocks. Following a downturn that has lasted almost two years, has the Australian sector finally bottomed?

We reviewed Clinuvel Pharmaceuticals, Dimerix, Imugene, and Neuren.

Dimerix (DXB: $0.16) has signed a licensing deal for its lead compound, DMX-200, with Advanz Pharma. The deal gives Advanz rights to the use of DMX-200 for the treatment of FSGS (Focal Segmental Glomerulosclerosis) in Europe, the UK, Canada, Australia and New Zealand.

Dimerix (DXB) CEO Nina Webster had encouraging news to share regarding the status of DXB's ACTION3 trial at the 17th annual Bioshares Biotech Summit. The pivotal Phase III trial is a randomised, double-blind, placebo-controlled trial of the efficacy and safety of DMX-200 for the treatment of Focal Segmental Glomerulosclerosis (FSGS), a rare form of kidney disease.

Dimerix (DXB: $0.072) is seeking to raise $12 million at $0.08 per share. Confirming the difficult capital markets, the raise will include a rights issue and also convertible note financing.

Dimerix (DXB: $0.17) has completed recruitment of the first part of its Phase III study in the kidney disease FSGS (focal segmental glomerulosclerosis) with 72 patients. It will now move into the second part where an additional 72 patients will be treated for 35 weeks with placebo or active drug.

Dimerix (DXB: $0.165) has reached around 40% recruitment into the first part of its Phase III focal segmental glomerulosclerosis (FSGS) study (as of mid September). The global study is seeking to recruit 286 patients for final analysis across 70 sites. The interim readout will be on 72 patients measuring proteinurea after 35 weeks of treatment.

During the pandemic, Dimerix (DXB: $0.17) was very pleased to have been able to complete two Phase II kidney disease studies. The company has now moved to a Phase III program in FSGS (kidney disease) involving 75 sites spread across 12 countries, including in the US where the company recently gained FDA approval (IND) to commence its study there as well. The first patient was treated in this study this week.

Dimerix CEO Nina Webster said that sclerotic kidney disease is a progressive three mechanism cycle that results in an acceleration of the disease as it progresses to end stage kidney failure. The drugs currently on the market all focus on the first mechanism of this disease by reducing hypertension across the bloodstream.