ASX-listed AusBiotech member Dimerix (ASX:DXB) takes out the Blake Award for Excellence after a knock-out year including an FDA conditional approval and key commercial partnerships.
Clinical-stage biopharmaceutical company Dimerix was awarded the Blake Award for Excellence (the Blakey) at the recent Bioshares Biotech Investment Summit in Fremantle, Western Australia.
In May 2024, Dimerix inked a deal worth AU$120.5 million with Taiba, providing Taiba with exclusive rights to register and commercialise DMX-200 for the treatment of kidney disease in key Middle East countries including United Arab Emirates (UAE), Saudi Arabia, Oman, Kuwait, Qatar, Bahrain and Iraq.
This comes after Dimerix struck a $230m licensing deal with multinational pharmaceutical company Advanz in October 2023, which covers the European Economic Area, UK, Switzerland, Canada, Australia, and New Zealand for commercialisation of DMX-200 for the treatment of FSGS following regulatory approval.
The FDA granted Dimerix conditional approval for the brand name QYTOVRA for its DMX-200 in September 2023. Since the FDA's conditional approval was granted in September 2023, Dimerix's share price has risen from $0.070 to $0.52 cents (as at 16 July 2024). Dimerix ranked #5 in the Q1 2024 top earner rankings according to the latest AusBioStocks data (March 2024) which tracks Australia's 178 ASX-listed life science companies.
The drug development company was awarded the Blakey Award during the two-day summit held in Freemantle on 12-13 July, with company CEO Nina Webster accepting the accolade on behalf of the company.
Dimerix announced positive interim analysis results in March 2024 from its ACTION3 Phase 3 trial of DMX-200 in patients diagnosed with rare kidney disease focal segmental glomerulosclerosis (FSGS). The positive Phase 3 interim analysis results pushes DXB-200 a step closer to potential market approval, following 12 years of work since the drug was first identified for use in the kidney disease.
Interim analysis indicates that DMX-200 is currently outperforming the placebo in reducing proteinuria, as measured statistically, within a significantly larger participant group compared to its earlier Phase 2 trial involving eight patients. Dimerix reported that the interim analysis suggests the potential for a statistically significant and clinically meaningful reduction in proteinuria at the study's conclusion.
Dimerix's ACTION3 clinical trial has now formally expanded into Part 2 of the study and to April 30, 2023, had randomised and dosed 98 patients with FSGS. The second interim analysis is planned to be carried out after the first 144 patients complete about 35 weeks of treatment.
Attracting round 200 of Australia's leading company executives and investors, the Bioshares Biotech Investment Summit features around 25 speakers with special sessions, master classes, and presentations focused on central themes to explore in-depth business operations and challenges that are relevant to many companies in the sector.
The Bioshares Biotech Investment Summit was first founded by David Blake and Mark Pachacz, the co-editors and independent analysts behind the popular Bioshares publication.
The Summit was established to enable investors and CEOs to meet and gain greater insights, away from day-to-day business pressures. The Summit began as a high-level event that has become a feature of the biotech investment calendar in Australia as well as an excellent networking opportunity.
In 2022 the Blake Award for Excellence ('The Blakey') was introduced in recognition of Bioshares Co-Founder David Blake and the significant impact he had on the sector. The inaugural winner in 2022 was Telix Pharmaceuticals for the rapid commercialisation of its radiopharmaceutical pipeline, while Neuren Pharmaceuticals took out the 2023 award for the development, regulatory approval, and successful market launch of DAYBUE™ for Retts syndrome, with US partner Acadia.
