Cynata Therapeutics gets approval for clinical trial on COVID-19

Cynata Therapeutics ASX CYP clinical trial COVID-19 ethics approval Cymerus mesenchymal stem cells MSCs
The MEND trial will take place in Australia to investigate early efficacy of Cymerus' mesenchymal stem cells.

Biotechnology company Cynata Therapeutics (ASX: CYP) intends to develop a treatment for COVID-19 by repurposing its Cymerus mesenchymal stem cells (MSCs) products and research.

In a statement to the market, Cynata said it had received ethics committee approval to commence a clinical trial in Australia to investigate early efficacy of Cymerus MSCs in adults admitted to intensive care with COVID-19.

The new MEND (MEseNchymal coviD-19) trial will be conducted at centres in New South Wales in collaboration with the Cerebral Palsy Alliance Research Institute and investigators from the COVID-19 Stem Cell Treatment (CSCT) Group.

According to Cynata, the study will be an open-label, randomised controlled clinical trial to investigate the early efficacy of Cymerus MSCs in 24 adult patients admitted to intensive care with COVID-19 and respiratory distress.

Twelve patients will be randomised to receive Cymerus MSC infusions, in addition to standard of care, while 12 patients will be randomised to the control group and will receive current standard of care.

The development was hailed as a “major milestone” by Cynata’s chief executive officer and managing director Dr Ross Macdonald.

“Our substantial pre-clinical database in relevant disease models, together with the urgent need for more effective treatments for critically ill patients with COVID-19, allowed us to accelerate planning and rapidly achieve ethics committee approval,” he said.

“This trial forms part of a broader clinical development strategy for our Cymerus MSC product to be trialled in COVID-19 patients in other countries.”

“Our decision to focus on this new clinical development area is a logical and prudent step based on the current global environment and Cynata’s solid pre-clinical foundations in respiratory and related diseases,” Dr Macdonald said.

Cynata also stated that its Cymerus technology had already “demonstrated promising pre-clinical trial results” in several conditions that can arise from a severe COVID-19 infection and acute respiratory distress syndrome (ARDS).

ARDS is an inflammatory process leading to a build-up of fluid in the lungs and respiratory failure that can occur due to infection, trauma and inhalation of noxious substances – one of the most common life-threatening complications of COVID-19.

“The MEND trial will build on Cynata’s strong pre-clinical study results in ARDS, sepsis and cytokine release syndrome, all of which are common hallmarks of severe COVID-19 cases,” the company said.

Elsewhere in the pipeline

In addition to developing a potential treatment for COVID-19, Cynata also published updates relating to its existing clinical program and drug pipeline.

Currently, the company is preparing to commence a clinical trial in partnership with FUJIFILM to progress development of CYP-001, the Cymerus product for the treatment of graft-versus-host disease (GvHD).

However, the impact of COVID-19 on company operations has been significant with Cynata admitting that while clinical trial recruitment restrictions remain in place, the study start-up activities for its osteoarthritis (OA) and critical limb ischaemia (CLI) phase 2 trials are continuing.

The phase 2 OA trial has been reviewed by The University of Sydney Human Research Ethics Committee, which granted approval in principle, subject to the review of certain additional information, with the final approval expected “in the near future”, Cynata said.

Meanwhile, the phase 2 CLI trial, which was approved by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) in January this year, has also been approved in Australia from the Melbourne Health HREC.

However, the effects of COVID-19 are expected to disrupt the trial and have a continued impact on potential recruitment for a lengthy period because patients with CLI are at high risk of developing serious complications of COVID-19, due to their age and underlying medical conditions.

Cynata said it be imprudent to commence recruitment under these circumstances, even after more general restrictions are relaxed.

As a result, the biopharmaceutical company said it decided to re-direct its financial and operational resources to focus on its COVID-19 and ARDS development strategy to accelerate clinical development and the attainment of potential value catalysts.