08 June 2020
Lamellar position LAMELLASOME™ in COVID-19 Treatment
COVID-19 is a disease characterised by two distinct phases:
Initially, an acute viral illness typically similar in severity to influenza and lasting around 3 to 5 days and resolving in some 80% of cases with minimal medium to long-term sequelae.
In some people, the disease has a second phase typified by failure to “bounce-back” followed by a rapid decline into profound ill-health at about day 6 to 8. At this stage a viral pneumonia/pneumonitis ensues as the virus targets alveolar type II pneumocytes. The capacity of the lungs to maintain normal homoeostasis is compromised and acute respiratory distress syndrome (ARDS) may ensue. Pulmonary support, CPAP or ventilation, becomes unavoidable in many cases. Some 50% of ventilated patients do not survive.
“The mechanisms through which severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes lung damage are only partly known, but plausible contributors include a cytokine release syndrome triggered by the viral antigen, drug-induced pulmonary toxicity, and high airway pressure and hyperoxia-induced acute lung injury secondary to mechanical ventilation.” (1)
An as-yet ill-characterised possible third stage is emerging. A proportion of severe disease survivors may progress to a range of debilitating chronic and perhaps progressive sequelae including, notably, pulmonary fibrosis.
LAMELLASOME Is a synthetic mimetic of non-alveolar lamellar bodies, initially developed for intended use in cystic fibrosis and other chronic lung conditions, notably Idiopathic Pulmonary Fibrosis (IPF). In collaboration with a team at the prestigious Roslin Institute, Edinburgh, LAMELLASOME™ has been studied in a sheep model of radiation induced lung injury (RILI).(2) RILI is known to have parallels with the lung injury now seen in COVID-19, including:
Other forms of acute lung injury display similar features.
Our in-vivo sheep-lung model study featured the administration of nebulised LAMELLSOME™ prior to the radiation of one lung lobe, using other lobes as controls.
In brief, this study showed that there was clear histological evidence that lung tissue exposed to radiotherapy without prophylactic LAMELLASOME™ treatment was more severely damaged than protected lobes and, in particular, that there was an abatement of the pro-inflammatory response in the alveolar interstitium and a significant reduction in myofibroblast generation and collagen deposition in “protected” lobes.
A prior in-vitro study demonstrated a LAMELLASOME™ concentration- dependent inhibition of TGF-beta1 mediated myofibroblast generation.
We are guided to believe that our study indicates a protection against acute radiation induced lung injury and a possible prevention or mitigation of ensuing fibrotic lung disease.
We conclude that there are strong grounds for inferring that LAMELLASOME™, administered before the transition from phase 1 to phase 2 of the disease process described earlier, has the potential to prevent or at least mitigate progression of the disease to pneumonitis and ARDS, promoting survival and also possibly protecting the lungs of survivors against fibrotic sequelae that are now considered a possible long term source of disability in a proportion of survivors.
As a mimetic of a naturally occurring vesicle in human biology, LAMELLASOME™ is safe and has been demonstrated conclusively to be so in appropriate regulatory studies and clinical studies in the eye and mouth. As such, it is ready to go to the clinic in COVID-19 as soon as a necessary quantity of GMP-grade material has been manufactured - i.e. within the current calendar year.
LAMELLASOME™ has been developed by Lamellar Biomedical Limited, a pharmaceutical company based in Central Scotland and supported by Scottish Enterprise, private and institutional investors.
For Further Information please contact:
Chief Financial Officer and Commercial
Lamellar Biomedical Ltd