CEO Damien Hancox outlines next step after constructive scientific advice meeting with regulatory agency
London – SpectrumX, a UK-based healthcare and pharmaceutical company, today announces that following a constructive scientific advice meeting with the Medicines and Healthcare products Regulatory Agency (MHRA) on Monday, 14th November, the Company is prepared to move forward with the next stage in clinical development of its respiratory drug candidate SPX-001.
Per regulatory guidelines, SpectrumX will submit a combined Clinical Trial and Ethics Committee application for a placebo-controlled phase Ib influenza viral challenge study of SPX-001 in healthy volunteers to the MHRA in December 2022.
SPX-001 is SpectrumX’s nebulised respiratory infection drug candidate, based on the Company’s licensed hypochlorous acid (HOCl)-based SPC-069 drug substance, which is believed to have broad-spectrum antipathogenic properties.
Commenting, Damien Hancox, CEO of SpectrumX said: “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 authorisation 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 trialling what we believe is a revolutionary treatment for respiratory infections.”
Dr Donna Lockhart, Consulting Head of Medicines at SpectrumX, said: “After productive discussions at a scientific advice meeting with the MHRA, during which we presented our lab-driven data, supporting evidence from existing literature, and key features of our novel solution, SPX-001, supporting its potential effects in combating respiratory infections, as well as our proposed clinical study protocol, I am pleased that we are one step closer to starting our clinical trial programme and the subsequent processes that are essential to market authorisation.”
If approved, this will be the first in-human trial to deliver SPX-001 via a nebulizer to test its efficacy and safety versus a placebo treatment in healthy subjects infected with influenza. Following successful completion of the planned trial, SpectrumX will move forward with further trials in patients with respiratory infections to gather the additional necessary data for a market authorisation approval.
As previously announced, SpectrumX has already begun the production process for SPX-001, working with a GMP-certified partner, which will accelerate trial-readiness once requisite approvals have been received.