Healthcare and pharmaceutical firm SpectrumX has announced that it is prepared to proceed with the clinical development of SPX-001, its respiratory drug candidate.
The latest move comes after the company’s constructive scientific advice meeting with the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) earlier this month.
Next month, the company plans to submit a combined clinical trial and ethics committee application to the MHRA for a placebo-controlled Phase Ib influenza viral challenge study of its respiratory drug candidate in healthy participants.
If approved, the Phase Ib study will be the first in-human trial to give SPX-001 through a nebuliser for evaluating its safety and efficacy, compared to a placebo, in healthy participants who are infected with influenza.
SpectrumX CEO Damien Hancox 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.”
The company intends to further conduct trials in respiratory infection patients after the successful completion of the planned Phase Ib trial.
This will help collect additional data that is required to seek market authorisation approval.
SpectrumX’s nebulised respiratory infection drug candidate, SPX-001, has been developed based on the company’s licensed hypochlorous acid (HOCl)-based SPC-069 drug.