- Source : Press Release
- Date : 2019-10-10
- Event type : Pre Clinical
- Companies : Dimerix Ltd.
Dimerix Announces New Drug Pipeline Candidate – DMX-700
MELBOURNE, Australia, 10 October 2019: Dimerix Limited (ASX: DXB), a clinical-stage biopharmaceutical company, today announced its next development pipeline candidate; DMX-700 for the treatment of Chronic Obstructive Pulmonary Disease (COPD). The new discovery was identified using Dimerix' proprietary Receptor-HIT assay and is one of a number of potential candidates under preliminary assessment.
The potential new pipeline opportunity, DMX-700 for COPD, is built on the Dimerix core competency of understanding the complex pharmacology of chemokine G Protein-Coupled Receptor (GPCR) targets, and thus has a good strategic fit with current business model and corporate strategy. As such, Dimerix can utilise its current core competencies and capabilities to execute the development program.
About Chronic Obstructive Pulmonary Disease (COPD)
COPD is a progressive and life-threatening lung disease. The primary cause of COPD is exposure to tobacco smoke (either active smoking or secondary smoke), however is also caused by exposure to indoor and outdoor air pollution, occupational dusts and fumes and long-term asthma. COPD is the fourth-leading cause of death in the world and although treatments exist to improve the symptoms of COPD, there is currently no way to slow progression of the condition or cure it. Moreover, among the top five causes of death globally, this disease is the only one with increasing mortality rates. In 2016, the Global Burden of Disease Study reported a prevalence of 251 million cases of COPD globally, and it was estimated that 3.17 million deaths were caused by the disease in 2015 (5% of all deaths globally in that year)*. The global COPD treatment market was valued at US$14 billion in 2017 and is projected to increase at a compound annual growth rate of 4.9% to 2026.
There is a significant unmet need in COPD, which is recognised by key organisations such as the National Institute of Health (NIH) and globally by the World Health Organisation (WHO) and the Centers for Disease Control and Prevention (CDC). In 2017, the NIH released the COPD National Action Plan in an effort to support research, diagnosis and treatment of the disease. Following this recognition, in 2018 the FDA issued revised guidance to help sponsors developing drugs to treat COPD. The new guidance will enable shorter clinical trials using surrogate and patientreported endpoints.
*WHO Factsheet – Chronic Obstructive Pulmonary Disease:
Receptor-HIT has identified a heteromer association between two receptors expressed on the lung. Both of these receptors have been independently implicated in the pathophysiology of COPD, however investigations into each single receptor have provided disappointing results to date. Dimerix anticipates that this is due to the heteromer nature of the receptor and has discovered that simultaneous inhibition of both receptors may significantly improve efficacy. The receptor targets and DMX-700 will remain undisclosed pending additional data and patent positioning.
Initial studies have been completed, and Dimerix has completed a key step in securing ownership over what it believes is an important new drug discovery by lodging a provisional patent application for DMX-700. The new provisional patent application, number 2019903606, has a priority date of 26 September 2019 and once granted would expire post 2040. It is anticipated that DMX-700 will be protected by Composition of Matter patents, Formulation patents and Method of Use patents, providing a strong competitive position.
Over the next 12 months Dimerix will conduct further proof of concept studies to perform the value-added verification in support of a robust product development pathway and patent position. DMX-700 is a New Chemical Entity, however the safety profile is well understood. As such, it is anticipated that Dimerix would initiate human clinical studies in less than 2 years.
“We have very high hopes for this drug candidate making a real difference in the lives of those suffering from COPD, where there is a significant unmet need”, Dimerix CEO and Managing Director commented. “Dimerix continues to assess potential opportunities that fit with the company strategy. We intend to focus on selecting appropriate pipeline candidates within our resource and funding capabilities. All potential opportunities screened are commercially attractive and could result in patient preferred products”.
An updated Corporate Presentation accompanies this release.
Cell-based assays are important tools used by the global pharmaceutical industry in drug discovery and development. Dimerix's patented cell-based assay, known as Receptor-HIT (Heteromer Investigation Technology), can be applied to a number of stages of the drug development process and has previously been used under licence by leading global pharmaceutical companies to profile a wide 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. Receptor-HIT can be applied to receptors such as G protein-coupled receptors (GPCRs); a large and important family of drug targets that play a central role in many biological processes and are linked to a wide variety of diseases.
Dimerix's core technology platform allows characterisation of different receptors that functionally interact and result in different pharmacology when natural ligands or small molecule drugs, peptides or antibodies bind to them. This platform technology was used to identify and characterise the GPCRs targeted in Dimerix's lead clinical program, DMX-200 – allowing rapid progress from proof of concept in vitro into Phase 2 clinical trials.
Dimerix (ASX: DXB) is a clinical-stage biopharmaceutical company developing innovative new therapies in areas with unmet medical needs for global markets. Dimerix is currently developing its proprietary product DMX-200 for both Diabetic Kidney Disease and Focal Segmental Glomerulosclerosis (FSGS). DMX-200 was identified using Dimerix' proprietary assay, Receptor Heteromer Investigation Technology (Receptor-HIT), which is a scalable and globally applicable technology platform enabling the understanding of receptor interactions to rapidly screen and identify new drug opportunities. Receptor-HIT is licensed non-exclusively to Excellerate Bioscience, a UK-based pharmacological assay service provider with a worldwide reputation for excellence in the field of molecular and cellular pharmacology.
DMX-200 is the adjunct therapy of a chemokine receptor (CCR2) antagonist administered to patients already receiving irbesartan, an angiotensin II type I (AT1) receptor blocker and the standard of care treatment for kidney disease. DMX-200 has granted patents in various territories until 2032.
In 2017, Dimerix completed its first Phase 2a study in patients with a range of chronic kidney diseases. No significant adverse safety events were reported, and all study endpoints were achieved. In a subsequent sub-group analysis, significant clinical efficacy signals were seen in the diabetic group.
DMX-200 administered to patients already taking irbesartan reduced proteinuria levels by a further 36%. This reduction in proteinuria is highly correlated with improved renal function and delay in kidney failure and dialysis. The compelling results from this study prompted the decision to initiate two different clinical studies in 2018: one for patients with Diabetic Kidney Disease; and the second for patients with another form of kidney disease, Focal Segmental Glomerulosclerosis (FSGS).
FSGS is a serious and rare disease that attacks the kidney's filtering units (glomeruli) causing serious scarring which leads to permanent kidney damage and kidney failure and for which there is a recognised medical need for a new or improved treatment. FSGS affects both children and adults.
DMX-200 for FSGS has been granted Orphan Drug Designation by the FDA and EMA. Orphan Drug Designation is granted to support the development of products for rare diseases and qualifies Dimerix for various development incentives including: seven years (FDA) and ten years (EMA) of market exclusivity if regulatory approval is received, exemption from certain application fees, and an abbreviated regulatory pathway to approval.
Related Presentation About DMX-700: https://investors.dimerix.com/DownloadFile.axd?file=/Report/ComNews/20191010/02157355.pdf