- With COVID-19 causing serious respiratory distress and mortality in patients, healthcare companies across the world have ramped up their efforts to rapidly develop vaccines or treatments for the fatal disease.
- Noxopharm last week notified about the commencement of its NOXCOVID clinical program with a Phase 1 clinical trial in Europe, targeting at confirming safety and proof-of-principle of Veyonda® in COVID-19 patients to prevent progression into virally-induced septic shock.
- Mesoblast is continuing with a randomized controlled Phase 3 trial in up to 300 patients, assessing whether remestemcel-L can lessen the high mortality with severe/moderate ARDS.
- DMX-200 has recently been selected for inclusion in the protocol as a novel treatment arm in the global REMAP-CAP program, targeted at treating patients suffering from ARDS caused by COVID-19.
The outbreak of coronavirus pandemic has driven the healthcare sector into spotlight, initiating a race to develop preventive and therapeutic interventions. The severity of COVID-19 can be comprehended by over 10 million cases and more than 500k deaths reported so far across the globe, with no specific treatments or vaccines available for the disease.
The danger with coronavirus infection rests in its progression from a mild to a fulminant and overwhelming condition characterised by acute respiratory distress syndrome (ARDS), respiratory failure, multi-organ failure, blood clotting problems and septic shock. Treatment is limited to general standard-of-care which includes supportive therapies comprising antibiotics and use of ventilators. Another key concern is that hospital facilities are at risk of being flooded in the short-term by numerous patients requiring admission to ICUs (intensive care units).
With COVID-19 causing serious respiratory distress and mortality in patients, healthcare companies across the world have ramped up their efforts to rapidly develop vaccines or treatments for the fatal disease.
At the global level, companies like Moderna Inc, AstraZeneca, Gilead Sciences, Pfizer and BioNTech SE are garnering attention toward developing vaccines or treatments against coronavirus. In the meantime, some ASX-listed entities are also in the spotlight for their efforts toward evaluating potential COVID-19 treatments, including Noxopharm Limited (ASX:NOX), Mesoblast Limited (ASX:MSB) and Dimerix Limited (ASX:DXB).
Noxopharm Ltd Investigating Veyonda®’s Potential in COVID-19 Treatment
Clinical-stage oncology drug development company in Australia, Noxopharm Limited (ASX:NOX) is evaluating the active ingredient in Veyonda®, idronoxil, in COVID-19 patients at risk of developing ARDS and multi-organ failure.
Noxopharm has announced the commencement of its NOXCOVID clinical program with a proposed Phase 1 clinical trial in Europe, targeted at confirming safety and proof-of-principle of Veyonda® in a timely and cost-effective way. The Company is targeting patients with moderate respiratory distress to prevent progression into virally-induced septic shock, that has no effective treatment beyond supportive intensive care to date.
The clinical trial aims to confirm Veyonda®’s ability to block or substantially lower the development of the ‘cytokine storm’ believed responsible for many COVID-19 deaths. The figure below exhibits the biological rationale for Veyonda®’s use in COVID-19 patients with poor lung function, including patients with ARDS who are at risk of acquiring a cytokine storm:
While several clinical trials are undergoing worldwide to inhibit the function of individual cytokines, Noxopharm believes that its approach to obstruct the STING pathway, thereby blocking the cytokine storm process at its roots is a more optimal approach.
While laboratory work has validated Veyonda®’s potential to block the formation of STING-mediated cytokines involved in septic shock, Noxopharm now intends to confirm this finding within in the clinic via a Phase 1 study in Europe.
By offering the potential to impede the production of a broad range of cytokines, Noxopharm’s approach brings hope of ceasing the rapid deterioration of COVID-19 patients whose lung functions have be compromised by the infection.
As on 29th June 2020, NOX has delivered a return of over 40 per cent in the last three months.
Mesoblast Assessing remestemcel-L for COVID-19 Lung Disease
Biopharmaceutical player, Mesoblast Limited (ASX:MSB) is evaluating its anti-inflammatory cell therapy remestemcel-L for treatment of ARDS, the principal cause of death in COVID-19 infection.
Mesoblast is continuing with a randomized controlled Phase 3 trial in up to 300 patients being enrolled in up to 30 sites across the US, assessing whether remestemcel-L can lessen the high mortality with severe/moderate ARDS. The Company has already attained improved respiratory and functional outcomes from Phase 2 trial in patients suffering from an elevated state of inflammation and COPD (chronic obstructive pulmonary disease).
Mesoblast’s clinical trial results attained so far support the potential of remestemcel-L to efficiently treat inflammatory lung diseases, like ARDS and acutely decompensated COPD.
The Phase 2/3 clinical trials were initiated after Mesoblast obtained promising results with remestemcel-L in COVID-19 ARDS under emergency compassionate use, where 75 per cent (7 out of 12) of ventilator-dependent patients were able to get rid of ventilators within an average of ten days.
Mesoblast has already received clearance from the FDA for an Investigational New Drug (IND) application to treat patients with ARDS caused by coronavirus infection with intravenous infusions of remestemcel-L.
In May 2020, the Company also completed a capital raising of $138 million, targeted to expand manufacturing of remestemcel-L for treating critically sick patients suffering with diseases triggered by cytokine release syndromes connected with high mortality, especially COVID-19 ARDS.
As on 29th June 2020, MSB has delivered a return of over 120 per cent in the last three months.
Dimerix Getting Set for REMAP-CAP
Australia-based clinical-stage biopharmaceutical company, Dimerix Limited’s (ASX:DXB) proprietary product DMX-200 has lately been selected for inclusion in the protocol as a novel treatment arm in the global Randomised, Embedded, Multifactorial Adaptive Platform trial for Community-Acquired Pneumonia (REMAP-CAP) program targeted at treating patients suffering from ARDS caused by COVID-19.
DMX-200 has been selected based on the compelling scientific rationale and unique potential to treat COVID-19 related issues.
Endorsed by WHO, the REMAP-CAP clinical study is funded by a consortium of non-government and government organisations. Subject to regulatory approval, the study aims to directly compare the treatment effect of several study treatment alternatives on the clinical results of COVID-19 patients needing hospital care.
As per Dimerix, after regulatory approval, DMX-200 could be the only investigational new drug in REMAP-CAP clinical study since all the other chosen candidates are a repurposing of existing approved drugs with potential for COVID-19.
DMX 200 is expected to benefit COVID-19 patients by reducing the inflammatory response in the lungs and thus lowering inflammation and fibrosis, potentially benefiting ARDS patients.
Dimerix would work closely with REMAP-CAP to rapidly obtain the necessary regulatory and ethics approval, following which the Company would:
- Supply DMX-200 to clinical studies globally
- Prepare DMX-200 regulatory submissions
- Provide technical support to the global REMAP-CAP team
- Commercialise DMX-200 in the event of positive clinical outcomes
To support activities associated with REMAP-CAP study of DMX-200, Dimerix has recently raised $5.8 million through a Placement activity.
As on 29th June 2020, DXB has delivered a return of over 190 per cent in the last three months.
The rising number of coronavirus cases and non-availability of any specific treatment or vaccine to prevent or treat COVID-19 so far offer an enormous commercial opportunity for all these healthcare players to discover a successful treatment for the lethal disease. As death rate associated with ARDS caused by any factor (including coronavirus) is considerably high, benefits of a fast-tracked treatment are likely to extend beyond the impact of COVID-19.