SuperTrans Medical has announced the appointment of three Australian companies to play pivotal roles in an upcoming clinical drug trial that offers new hope in the plight against antimicrobial resistance (AMR), which the World Health Organisation (WHO) describes as a 'silent pandemic' and one of the biggest threats to global health.

International biopharmaceutical company SuperTrans Medical has announced the appointment of CMAX, Avance Clinical and Agilex Biolabs as its key clinical research partners to conduct the roll-out of Phase 1 human clinical trials in Australia during 2021 for its revolutionary new antibiotic.   

The drug uses SuperTrans Medical's patented Intelligent Repurposing? technology, originally invented at Stanford University. This approach involves the chemical attachment of a permeator unit to an existing mainstay antibiotic, which leads to its 'revitalisation' by enabling it to effectively penetrate into and eradicate urgent threat bacterial pathogens.

"Antibiotic-resistant infections are a serious threat to global health and with only four new classes of antibiotics introduced since the early 1960s, clinicians just don't have enough to work with. It is predicted that the threat will continue to grow over the next three decades and could potentially reach a point where 10 million people worldwide succumb to antibiotic-resistant infections by 2050[1]," said said Dr Lewis Neville, CEO, SuperTrans Medical.

He continued, "We have worked tirelessly to help find a creative solution. With the highly promising safety and efficacy results we've seen to date, we believe our repurposed and retargeted antibiotic could bring a much-needed and new panacea to thwart these urgent threat pathogens."

Encouraged by successful pre-clinical results, which will be published in the April issue of Antimicrobial Agents and Chemotherapy (AAC), SuperTrans Medical recently announced plans to begin clinical trials in Australia later this year for its lead indication, complicated Urinary Tract Infections (cUTIs).

UTIs represent one of the most frequent infectious diseases, affecting 150-250 million people each year worldwide. E. coli bacteria, the major culprit of UTIs has become increasingly resistant to fluoroquinolone antibiotics and there is therefore a clear unmet medical need for novel therapies targeting difficult-to-treat UTIs. It is estimated that UTIs will cost the Australian healthcare system $1.6 billion a year within the next decade if efforts are not swiftly undertaken to arrest the rise of antibiotic resistant bacteria.[2]

Commenting on the Company's appointment of the Australia-based clinical research organisations (CRO), Dr Neville said: "We are delighted to be working with three of Australia's most renowned and respected companies in the area of clinical research to deliver our Phase 1 study. CMAX Clinical Research, Avance Clinical and Agilex Biolabs are all global leaders in their fields, and will bring a level of experience and rigour that is unparalleled. The fact that they are all headquartered in the city of Adelaide, within its BioMed hub, is another significant advantage."

South Australian Minister for Trade and Investment Stephen Patterson said clinical trials like this one are extremely important to both the region's economy and to its reputation as leaders in the field of cutting-edge drug development.

"The Health and Medical Industries Sector Plan, as part of the Marshall Liberal Government's Growth State Plan, looks forward to 2030 with a target to more than double the Health and Medical Industries economic contribution to South Australia, increasing its value from $2.3 billion to $5 billion," Minister Patterson said.

"Within the plan, clinical trials have been identified by industry as a key enabler for growth, and today's announcement is a major win for the state, highlighting the vast opportunities in this fast-growing sector."

CMAX, Australia's longest established Phase 1 Unit facility for clinical trials, will prepare for and carry out the Phase 1 study at Royal Adelaide Hospital according to strict ethical and regulatory requirements.

Commenting on SuperTrans Medical's Phase 1 trials, CMAX Medical Director, Professor Sepehr Shakib said, "The available antibiotic arsenal to fight antibiotic resistance and the rise of superbugs is dwindling, with a limited pipeline of drugs currently in pre-clinical and clinical development. That is why SuperTrans Medical's novel antibiotic technology is so exciting! We are delighted to be working on this project as it could ultimately prove to be an extremely important breakthrough in the fight against antibiotic resistance."

Leading Australian CRO Avance Clinical will be managing and coordinating all the activities surrounding the Phase 1 trial. Yvonne Lungershausen, CEO of Avance Clinical said, "As a full service clinical CRO for biotech clinical trials, Avance Clinical is well placed to support international clients like SuperTrans Medical in their clinical development program. The majority of our clients are international biotechs who are seeking to take advantage of Australia's unrivalled ecosystem for clinical studies which features scientific excellence, rapid and streamlined regulatory processes, and an attractive research costs rebate of 43.5%."

Agilex Biolabs will provide all the required bioanalytical services and support associated with the clinical trial. Agilex Biolabs CEO, Jason Valentine said, "As Australia's largest and most experienced labs for biotech clinical trials, we are excited to have been selected by SuperTrans Medical to be involved in the Phase 1 clinical trial. We look forward to applying our deep bioanalytics experience to this important research aimed at solving one of the world's most pressing medical issues, antimicrobial resistance (AMR)."

SuperTrans Medical's clinical trial in healthy volunteers is expected to commence late in the 2021 calendar year in Adelaide, Australia.

[1] O'Neill report: The Review on Antimicrobial Resistance

[2] OUTBREAK's One Health antimicrobial resistance economic perspective

About SuperTrans Medical

SuperTrans Medical Limited (STM) is a biopharmaceutical company developing novel antibiotics that target difficult-to-treat, multi-drug resistant bacteria, also known as superbugs. This is achieved through the Intelligent RepurposingTM of existing FDA-approved medicines by conjugation with different structural formats of STM's permeator technology.