Next Step in Clinical Development of Respiratory Drug Candidate SPX-001 Confirmed

SpectrumX, a UK-based healthcare and pharmaceutical company, announced plans to advance with the next stage in clinical development of its respiratory drug candidate, SPX-001, in the United Kingdom.

The company 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 participants to the Medicines and Healthcare products Regulatory Agency (MHRA) in December 2022 per regulatory guidelines.

SPX-001 is a nebulized respiratory infection drug candidate based on SpectrumX’s licensed hypochlorous acid (HOCI)-based SPC-069 drug substance. The substance is believed to have broad-spectrum antipathogenic properties.

“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,” said Damien Hancox, CEO of SpectrumX, in a press release. “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.”

If the application is approved, it will be the first in-human trial to supply SPX-001 via a nebulizer to test its efficacy and safety in comparison to a placebo treatment in healthy subjects infected with influenza. After a successful completion of the planned trial, SpectrumX will then proceed with further trials in patients with respiratory infections to gather the additional necessary data for a market authorization approval.

SpectrumX is already in the production process for SPX-001 and working with a good manufacturing practice (GMP)-certified partner, which will quicken the trial-readiness once the approvals are received.

“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 authorization,” said Donna Lockhart, MD, Consulting Head of Medicines at SpectrumX, in a press release.

Source: BusinessWire