Trimunocor Ltd, focused on treating respiratory and infectious disease, today announced it has initiated a new programme to prevent infection and treat coronavirus related disease due to Covid-19 using its first-in-class carbohydrate binding molecules based on SP-D called ImmunoCOV-PD.
SARS-CoV-2 has spread globally and infected millions of people and this number is growing exponentially. However, there are no effective treatments to treat or prevent the disease caused by this virus, Covid-19. Infection with SARS-CoV-2 critically infects alveolar type-II cells, which are the cells that produce the natural lung defence molecule SP-D. SARS-CoV-2 infected individuals develop a cough with fever and in a many of cases subsequently viral pneumonia. Patients with SARS-CoV-2 pneumonia can progress and develop severe acute respiratory distress syndrome (SARS) which require intensive care in ICU. Up to half of those with critical disease currently do not survive.
Our collaborators at University College London have worked on lung defence molecules SP-A and SP-D for over 20 years and patented new recombinant analogues of these molecules. SP-A and SP-D are crucial lung innate immune proteins which protect the lung against viral pathogens and supresses inflammation to keep the lungs healthy. Recombinant fragment SP-D is well characterised and binds to and neutralises several viruses including Respiratory Syncytial Virus (RSV) and in the same way recognises the coronaviruses which give rise to severe acute respiratory syndrome (SARS). We propose to treat patients with SARS due to coronavirus infection, initially those with SARS-COV-2 infection, by delivering rfhSP-D directly to their lower respiratory tree.
The clinical trial will be a single centre, open-label, lead-in study named TRICOVER. The primary objectives of the TRICOVER study are to evaluate the safety and efficacy of the treatment drug, ImmunoCOV-PD therapy as a treatment for patients with moderate to severe acute respiratory distress (SARS) due to SARS-COV-2. The primary efficacy endpoint will be number of ventilator-free days through to day 28, a well-established endpoint for ARDS trials, that evaluates the intervention’s combined impact on survival and reduction in requirement for invasive mechanical ventilation in ICU. The secondary objectives will be to evaluate pulmonary function, all-cause mortality, tolerability and quality of life (QoL) among survivors associated with COV-PD therapy.
Production of SP-D was thought to be problematic since it is a large and complex protein. At Trimunocor we have solved this issue with the help of Innovate UK and can now manufacture recombinant fragment human rfhSP-D at high levels and using scalable upstream and downstream processes commonly used in the pharmaceutical industry.
Neill Moray Mackenzie, CEO of Trimunocor, said: “We are committed to support the global effort to treat the coronavirus pandemic and believe our novel therapeutic modality has the potential to block access of Covid-19 virus to lung pneumocytes, the primary site of infection. This builds on proven pre-clinical efficacy of SP-D shown against other respiratory viruses including SARS-COV-1. Importantly, we expect that our approach should work well in preventing progression of disease in those who are the most at risk, namely those recently hospitalised with Covid-19 infection, preventing or reducing the pneumonia due to SARS and critically, reducing the requirement for invasive mechanical ventilation in ICU. We are looking to move rapidly into clinical studies within a year”
Howard Clark, a world leader in surfactant research, and Trimunocor co-founder, said, "Trimunocor's rfhSP-D platform provides a novel way of blocking viral infection and reducing inflammatory sequelae in the lung. It acts as a first line of immune defence against viruses such as Covid-19 and could prevent and reduce the symptoms of SARS. We are excited about its prospects because exploiting its natural immune activity against unchanging features essential to these viruses, means it could provide protection not only against current and also subsequently emerging strains".
Trimunocor is using its platform technology, rfhSP-D, a natural human fragment of SP-D (essentially a glycan-targeted carbohydrate-binding molecule) as a new universal therapeutic modality for the prevention and treatment of chronic lung disease in pre-mature babies and prevention of pneumonia during respiratory tract infections such as those due to coronavirus, and Respiratory Syncytial Virus (RSV).
Trimunocor’s lead product is a first-in-class anti-inflammatory product, CARE-PD in development for the treatment of bronco-pulmonary dysplasia in premature babies. Full scale GMP manufacture of the product for a first in man trial in preterm babies scheduled for 2021 is already underway.
Its second product in development is for the universal treatment, of RSV, and coronavirus Covid-19 infections. When administered intranasally in preclinical models, COV-PD has demonstrated prevention of RSV infection both in-vitro and in-vivo with no observed toxicity. The product will be in clinical trial early next year.
The Company is based in the UK and has partnered with the world-class scientific expertise and capabilities in surfactant biology in the laboratory of Professor Howard Clark in the University College London. Please visit www.trimunocor.com for more information.
Dr Neill Moray Mackenzie
Chief Executive Officer