SpectrumX Medical Limited
There is an immediate need for an efficacious, safe and cost effective treatment for COVID-19 globally. With the unusual situation of having Emergency Use Applications open to the company, a process of sometimes several years can currently be completed instead in 7 months. Additionally with the benefit of successful trial data on one respiratory infection it leaves the pathway open to the company to immediately begin exploring the multiple other applications for the treatment.
SpectrumX Medical provides ground-breaking inhalation treatments. Initial trials will prove safety and efficacy against COVID-19. Future product launches are planned for treatment of Pneumonia, Bronchitis, Asthma, Flu, and Common Cold.
SpectrumX Medical is focused on the applications of the HOCL licenses in the pharmaceutical sector. Our partner Spectrum Antimicrobials announced in November 2020 that they had finished development of SPC-069.
SPC-069 is a new class of therapy designed to treat viral, bacterial, and fungal infections in the lung and respiratory tract. This promising therapy was developed to eradicate not only common pathogens but also those caused by antibiotic resistant strains known as Super Bugs.
There is currently no competing product in the market which has been shown to be effective in this field.
SpectrumX are also supporting the Medical University Hospital Innsbruck who are undertaking a Phase 2 clinical trial for the nebulised treatment of COVID-19 patients using the novel SPC-069 formulation. This is currently at IRB sign off stage and has been excellently developed by Professor Germar Pingerra who will be leading the trial.
Nebulisers are medical devices that enable deposition (the dispersion and planting of water vapour and/or nebulised medication) into the deeper areas of the respiratory system, such as the lung tissue, this is a key treatment pathway for COVID-19.
The primary end points of the studies we hope to demonstrate is that inflammation symptoms are reduced, patients breathe easier after treatment, and the recovery times and reversal of symptoms happens within 2-5 days. Other benefits may include reduction of the viral load in the respiratory system, making it harder to transmit it to others. Many of the patients who contract COVID-19 also develop bacterial pneumonia. We believe that it may be possible to mitigate the pneumonia during nebulizing SPC-069 into the lung for the therapeutic treatment of COVID-19.
The focus of the trial is to establish that the use of the product can dramatically reduce hospitalisation stays for patients suffering from COVID-19. This is of particular interest because unlike vaccines, which may become ineffective against future variants of COVID-19, SPC-069 will be efficacious against all mutations of the viral infection.
The diagram below relates to a starting point of 1 million micro-organisms. If you spray a million target micro-organisms with a 99.9% kill disinfectant; 1000 will remain (3 Log). However, if you were to spray a million target micro-organisms with a 99.9999% kill disinfectant; then just 1 will remain.
SpectrumX HOCL products achieve the 6 Log reduction demonstrated in the image below.
Upon receipt of successful data from the trial SpectrumX will be submitting an emergency use authorisation to both the European Medicines Agency (EMA) as well as the Medicines & Healthcare products Regulatory Agency.
SpectrumX are confident that results from the trial will be positive and that the product can be brought to the market expeditiously.
Trials on similar (albeit we believe inferior) technologies have been undertaken by another UK company, Synairgen PLC. Synairgen’s SNG001 offering is based on Interferon Beta which is a far more complex and expensive technology. SpectrumX will be able to produce SPC-069 at a fraction of the cost and will “compete” in a marketplace with treatment prices stated at £2000 per patient.
Focus will then shift to a home use trial of the drug to help reduce hospitalisation numbers by allowing patients to self administer the solution easily at home.
Initial discussions have also begun with Chelsea & Westminster Hospital about an evaluation of the product to be used by anesthesiologists pre-intubating patients with COVID-19 and other bacterial and viral respiratory infections. This is an extremely concerning infection pathway which could be dramatically reduced by the sterilisation of the patient’s lungs reducing cross infection in hospital settings.
Past the current pandemic there are multiple applications for the product which the company plans to investigate the potential uses of SPC-069 against other respiratory infections. We believe that the product will be effective at treating: Bacterial pneumonia, Bronchitis, Influenza (Flu), Common cold.
UK Antivirals Taskforce
On April 26th the UK government launched an Antivirals Taskforce to identify treatments to be used at home by people who test positive for SARS-CoV-2 infection, to stop the virus spreading and speed up recovery time.
SpectrumX believe SPC-069 to be an excellent candidate for this purpose.
Handheld nebulisers are low cost and readily available. UK based manufacturing would allow for an uninterrupted supply chain for the UK
The product is fully developed and can be rolled out in time to meet the government targeted autumn deadline.
The direct mode of action through inhalation is believed to be faster acting than traditional ingestible antivirals.