SpectrumX said it had received a date for a scientific advice meeting with the UK Medicines and Healthcare products Regulatory Agency (MHRA) to discuss a human clinical trial programme for its antimicrobial drug SPX-001.
The meeting will take place in the final quarter of 2022 and discuss the available data supporting the start of human trials and the protocol for the Phase Ib human volunteer study, prior to a Clinical Trial Application (CTA) submission.
SpectrumX anticipates that if successful with the MHRA it will start the clinical trial in the first quarter of 2023.
That trial will use SPX-001 via a nebuliser to test its efficacy versus placebo treatment in subjects with Influenza A respiratory infection.
Following successful completion of the trial, the aim is to move forward with studies in patients with respiratory infection to gather data necessary for market authorisation.
SpectrumX has already begun the production process of SPX-001 for clinical trials, working with a leading GMP-certified partner, to create vials suitable for use by nebulisation.
Donna Lockhart, consulting head of medicines at SpectrumX, added: “I am pleased to initiate formal discussions of our clinical trial plans with the MHRA to progress our ground-breaking solution, SPX-001, to market.
“I look forward to a productive discussion with the MHRA, and to relaying our current lab-driven data, supporting evidence and proposed clinical trial protocol, as well as the important features of SPX-001 to combat respiratory infection caused by viruses.“
To learn more visit: spectrumx.com/
About SpectrumX
SpectrumX is a promising biotech firm with a lot of potentials. Investors are interested in the company because of its innovative HOCl treatment, which could become the standard of care for many conditions if clinical trials are successful. However, there is significant risk involved, as clinical trials could fail. For investors considering an investment in SpectrumX, careful consideration is advised.
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Company Name: SpectrumX
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Country: United Kingdom
Website: https://spectrumx.com
