The Company identifies critical milestones required to commence clinical trial programme
London, United Kingdom: SpectrumX, a UK-based healthcare and pharmaceutical company, is pleased to announce that is has a date for a scientific advice meeting with the UK Medicines and Healthcare products Regulatory Agency (MHRA) to discuss its human clinical trial programme.
SpectrumX has confirmed the scientific advice meeting with the MHRA will take place in Q4 2022, and will discuss the available data supporting the commencement of human trials with SPX-001 and the protocol for the Phase Ib human volunteer study, prior to submission of the Clinical Trial Application (CTA) submission. The MHRA meeting provides an opportunity for the Company to receive further guidance on SPX-001, the broad-spectrum anti-pathogenic medicine produced using the SPC-069 drug substance.
Following completion of the scientific advice meeting, SpectrumX anticipates it will submit a CTA to the MHRA in which formal authorisation will be sought from the MHRA and UK ethics committee to conduct the proposed clinical trial. This will be conditional upon satisfactory review and evaluation of the information submitted by SpectrumX in the CTA. Submission of the CTA application is planned for early 2023.
Contingent upon MHRA approval of the CTA, SpectrumX expects to conduct its first human clinical trial in Q1 2023. This will be the first trial to 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, SpectrumX plans to move forward with trials 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 of SPX-001 suitable for use by nebulisation. This is a critical step toward trial-readiness and will allow the Company to move quickly into clinical testing once the programme is approved by MHRA.
Dr Donna Lockhart, Consulting Head of Medicines at SpectrumX, said: “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. From that point and incorporating guidance from the MHRA, the Company will be well-positioned to advance to its clinical trial programme and the subsequent processes that are essential to market authorisation.”