You might be interested in
Health & Biotech
US reimbursement rate set for Lumos point-of-care respiratory test
Health & Biotech
Health Check: Biotech’s forgotten tortoises pick up the pace as sector emerges from two-year slump
Health & Biotech
Health & Biotech
This week marks World Antimicrobial Resistance Awareness Week (WAAW), which aims to put a spotlight on the growing threat of antimicrobial resistance and promote best practices to reduce the emergence and spread of drug-resistant infections.
The World Health Oganization (WHO) has described antimicrobial resistance (AMR) as a pressing global health and socioeconomic crisis, which has significant impacts on human and animal health, food production and the environment.
“As a result of drug resistance, antibiotics and other antimicrobial agents become ineffective and infections become difficult or impossible to treat, increasing the risk of disease spread, severe illness and death,” the WHO said.
The agency estimated that bacterial AMR was directly responsible for 1.27 million deaths worldwide in 2019 and played a role in 4.95 million additional deaths.
This year’s WAAW theme calls on the global community to educate stakeholders on AMR, advocate for bold commitments and take concrete actions in response to AMR.
Australian Antimicrobial Resistance Network (AAMRNet) is Australia’s leading multi-stakeholder expert group committed to combating the urgent global threat of AMR.
It is a public-private partnership established and operated by MTPConnect, an independent not-for-profit operating life sciences accelerator programs.
AAMRNet co-chair and MTPConnect CEO Stuart Dignam said the innovation pipeline for new antibiotics was drying up and not keeping pace with public health needs.
“When you consider that of the latest 24 antibiotics registered in Europe and the United States, only three are generally accessible to Australians, it’s clear different approaches are needed to ensure Australian patients have access to the medicines they need,” Dignam said.
“We need sensible incentives to stimulate investment in new discovery, translation, early clinical trials and, for antibacterial medicines that show promise, suitable reimbursement pathways.”
AAMRNet held a roundtable in Canberra on Monday to look at new approaches to better support development of, and access to, new antimicrobial technologies, like the UK’s subscription-style funding model for the pharmaceutical industry.
Here’s a few of the companies on the ASX working to combat the rise of AMR…
Recce Pharmaceuticals is tackling the global health problem of antibiotic-resistant superbugs with its new class of synthetic anti-infectives.
The company’s lead drug candidate RECCE 327 (R327), a fast-acting, broad-spectrum anti-infective against Gram-positive and Gram-negative bacteria, including antimicrobial resistant superbugs.
R327 is being investigated as an intravenous therapy for the treatment of urinary tract infections and urosepsis and as a topical gel (RECCE 327 Gel or R327G) for acute bacterial skin and skin structure infections (ABSSSI) including diabetic foot infections (DFIs) and burn wounds.
R327 has been added to the WHO’s report of Antibacterial Agents in Clinical Development and Preclinical Development and is the only compound categorised as an ATP production disruptor.
R327G has recently gained ethics approval for a registrational phase III trial in Indonesia investigating its use to treat DFIs.
Successful completion of the trial would enable Recce to replicate regulatory approval for R327G across the broader ASEAN region as a treatment for DFIs, addressing a critical unmet need for new therapeutics in countries facing increasing rates of antimicrobial resistance and infectious diseases.
R327G is also currently being investigated in a phase II study in Australia examining its efficacy in treating ABSSSI, which is advancing to its final stages of dosing.
“R327 aims to combat AMR in a variety of forms, by targeting Gram-positive and Gram-negative bacteria, including their superbug forms,” CEO James Graham said.
“The unique mechanism of action, which has been proven safe in humans, has demonstrated efficacy as both a topical gel and as an intravenous therapy.
“We aim to address the growing need for new methods to curb the growing threat of antimicrobial resistance.”
Nanosonics is an infection prevention company specialised in the automated decontamination of reusable medical instruments such as ultrasound and endoscopes.
Its Trophon technology for ultrasound decontamination has become standard of care in several countries, including the US, Australia and UK.
With more than 32,000 devices in operation, the Trophon device protects more than 27 million patients annually from the risk of cross contamination.
Nanosonics is now expanding into other markets in Europe and Asia Pacific.
The company’s latest innovation, CORIS, is designed to address one of the biggest unmet needs and challenges in medical instrument decontamination – the reprocessing of flexible endoscopes.
Nanosonics filed a de novo regulatory submission with the US Food and Drug Administration (FDA) in April this year and is forecasting approval within about a year.
“During World Antimicrobial Resistance Awareness Week it’s important to recognise that prevention is better than cure especially when it comes to infections associated with antimicrobial resistant organisms,” CEO and President Michael Kavanagh told Stockhead.
“Reusable medical instruments can be a vector for contamination with these types of organisms, therefore it’s imperative they are decontaminated effectively.
“The efficacy testing of our technologies includes testing against these types of organisms and has been found to be highly effective.”
This point-of-care diagnostic technologies company has developed the FebriDx rapid test to help doctors quickly and accurately differentiate a viral from bacterial acute respiratory infection.
With the rise in AMR, avoiding unnecessary use of antibiotics has become paramount. FebriDx qualitatively detects elevated levels of two proteins produced by the body’s immune response, which help differentiate between bacterial (C-reactive protein [CRP]) and non-bacterial (Myxovirus resistance protein A [MxA]) infections in a fingerstick blood sample.
In April, LDX announced that the peer-reviewed journal Infectious Diseases and Clinical Microbiology published positive results from a FebriDx study conducted at Spain’s Sant Joan de Déu Hospital.
The study, involving 216 paediatric patients, found that FebriDx could optimise antibiotic use and reduce unnecessary chest X-rays in children with acute febrile respiratory infections.
The Biomedical Advanced Research and Development Authority (BARDA), which is part of the US Department of Health and Human Services’ Administration for Strategic Preparedness and Response, recently awarded Lumos almost US$3m in undiluted funding.
The funding is part of a milestone-bound deal worth more than US$8m to support the next stage of clinical development for FebriDx.
CEO Doug Ward told Stockhead the BARDA deal would drastically expand use of the FDA-cleared device and reach in the market.
Additionally, Tenmile Ventures – a health investment company and wholly owned subsidiary of Andrew and Nicola Forrest’s private investment group Tattarang – recently acquired a 9.3% shareholding in LDX.
“Antimicrobial stewardship is a shared world responsibility,” Ward said, adding:
“We believe FebriDx is the type of innovation that should be adopted as it actively supports all of us to make better informed decisions about the appropriate use of antibiotics.”
At Stockhead, we tell it like it is. While Recce Pharmaceuticals and Lumos Diagnostics are Stockhead advertisers, the companies did not sponsor this article.