Clinical-stage biopharmaceutical company Dimerix (ASX: DXB) has announced plans to target the development of what it calls “an important new discovery” in the treatment of chronic obstructive pulmonary disease (COPD).
The DMX-700 drug was identified using Dimerix’s proprietary Receptor-HIT cell-based assay and if successful, will meet a significant unmet medical need in the pharmaceutical industry.
It is built on Dimerix’s core competency of “understanding the complex pharmacology of chemokine G Protein-Coupled Receptor (GPCR) targets”, and has been cited as a good strategic fit with the company’s current business model and corporate strategy.
Initial studies have been completed and Dimerix has completed a key step in securing ownership of DMX-700 by lodging a provisional patent application for the drug which would not expire before 2040 if approved.
Dimerix said it would conduct proof of concept studies on DMX-700 over the next 12 months in order to perform value-added verification in support of a product development pathway and patent position.
While the drug has been classified as a New Chemical Entity, the safety profile is believed to be well understood, allowing the company to proceed with its plan to initiate human clinical studies within the next two years.
Chief executive officer and managing director Dr Nina Webster said there are high hopes for the success of the drug in treating COPD.
“We have very high hopes for this drug candidate making a real difference in the lives of those suffering from this condition, where there is currently a significant unmet need,” she said.
Cell-based assays such as the Receptor-HIT (Heteromer Investigation Technology) technology platform are used by the pharmaceutical industry worldwide in drug discovery and development.
Dimerix said Receptor-HIT has already been applied to a number of stages of the drug development process and has previously been used under licence by leading pharmas to profile a range of receptor targets.
Compared with the traditional analysis of single target receptors in isolation, Receptor-HIT is able to identify differences in signalling behaviour when receptors interact as complexes, known as heteromers.
It can be applied to receptors such as GPCRs – a large family of drug targets which play a central role in many biological processes and have been linked to a wide variety of diseases.
Chronic obstructive pulmonary disease (COPD) is a progressive and life-threatening lung condition caused by exposure to tobacco smoke through active or passive smoking, indoor and outdoor air pollution, occupational dusts and fumes and long-term asthma.
The disease is the fourth-leading cause of death worldwide and is the only one of the world’s top five causes of death to have increasing mortality rates.
Although treatments exist to improve the symptoms of COPD, there is currently no way to slow the progression or cure the disease.
In 2016, the Global Burden of Disease Study reported 251 million cases of COPD globally, and it was estimated that 3.17 million deaths were caused by the disease in 2015 (equating to 5% of all deaths globally in that year).
In 2017, the global COPD treatment market was valued at US$14 billion and is projected to increase at a compound annual growth rate of 4.9% to 2026.
Unmet medical need
According to Dimerix, there is currently a significant unmet medical need for COPD patients which has also been recognised by the National Institute of Health, the World Health Organisation, and the Centres for Disease Control and Prevention.
In 2017, the NIH released the COPD National Action Plan in an effort to support research, diagnosis and treatment of the disease.
In 2018 the FDA issued revised guidance to help sponsors developing drugs to treat COPD, enabling shorter clinical trials using surrogate and patient-reported endpoints.
This week, Dimerix received a $1.18 million research and development tax incentive rebate for activities during the 2018/19 financial year.
The federal incentive program provides a tax cash rebate to support Australian companies undertaking research and development in various fields.
“This incentive plays a significant role in supporting innovation for companies like Dimerix which are engaged in clinical and late-stage product development in the biotech and pharmaceutical industry,” Dr Webster said.
The refund will enable Dimerix to continue with late-stage development, clinical studies and commercialisation of DMX-200 to treat diabetic kidney disease and focal segmental glomerulosclerosis.
The drug was also identified using Receptor-HIT.