Following a fruitful scientific advice meeting with the Medicines and Healthcare products Regulatory Agency on November 14th, SpectrumX, UK-based healthcare, and pharmaceutical company, has announced that it is ready to proceed with the next phase of clinical development of its respiratory drug candidate SPX-001.
For a placebo-controlled phase Ib influenza virus challenge trial of SPX-001 in healthy volunteers, SpectrumX will submit a joint Clinical Trial and Ethics Committee application to the MHRA in December 2022.
Based on the company’s licensed hypochlorous acid-based SPC-069 medicinal material, which is thought to have broad-spectrum antipathogenic capabilities, SPX-001 is SpectrumX’s nebulized respiratory infection treatment candidate.
“We believe SPX-001 could be a significant new weapon in the fight against viral respiratory infections, and this is a critical milestone in progressing our drug candidate toward targeted market authorization approval. We would like to thank the MHRA for their helpful guidance and responses to our initial proposal to begin human clinical trials, and we hope this brings us another step closer to trialing what we believe is a revolutionary treatment for respiratory infections.”
Commenting, Damien Hancox, CEO of SpectrumX
“After fruitful discussions at a scientific advice meeting with the MHRA, during which we presented our lab-driven data, supporting evidence from existing literature, key components of our novel solution, SPX-001, supporting its potential effects in battling respiratory infections, as well as our proposed clinical study protocol, I am pleased that we are one step closer to starting our clinical trial,” said Dr. Donna Lockhart, Consulting Head of Medicines at SpectrumX.
If authorized, this will be the first-in-human trial in which SPX-001 is administered using a nebulizer to compare the effectiveness and safety against a placebo in healthy patients with influenza. After the anticipated study is successfully completed, SpectrumX will proceed with subsequent studies in patients with respiratory infections to collect the extra information required for market authorization permission.
As previously stated, SpectrumX has already started the SPX-001 production process with a GMP-certified partner, which will hasten trial preparedness once necessary clearances have been obtained.
About SpectrumX
The goal of SpectrumX, a UK-based healthcare, and pharmaceuticals firm, is to introduce the NHS and other healthcare clients to the world’s most potent hand sanitizer and a revolutionary treatment for respiratory infections. Both goods make use of distinctive, patent-in-progress HOCl compositions. Human white blood cells naturally contain HOCl, which plays a crucial role in the immune system’s response to infection. Additionally, HOCl possesses direct antibacterial, antiviral, and antifungal properties. When applied on surfaces, it is the most potent disinfectant known and is well tolerated by people.