Start-up agreement is major step forward in readiness to conduct Phase 1b clinical trial of Company’s HOCl-based respiratory infection drug candidate, SPX-001
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Start-up agreement is major step forward in readiness to conduct Phase 1b clinical trial of Company’s HOCl-based respiratory infection drug candidate, SPX-001
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Partner and SpectrumX will align on detailed clinical trial protocol to discuss with the MHRA at Scientific Advisory Meeting, currently scheduled for 14 November 2022
London – SpectrumX, a UK-based healthcare and pharmaceutical company, today announces that it has signed a start-up agreement with an experienced leader with a strong background in conducting human challenge trials in infectious and respiratory diseases, to support the Company in the design and execution of a Phase I clinical trial for drug candidate SPX-001. The revolutionary therapy, based on SpectrumX’s licensed SPC-069 technology, is a hypochlorous acid (HOCl)-based nebulised treatment with broad-spectrum antipathogenic properties that has the potential to treat respiratory infections.
Per the partner’s policy, it will remain anonymous until after clinical trial agreement, which SpectrumX anticipates happening in due course after its Scientific Advisory Meeting with the Medicines and Healthcare products Regulatory Agency (MHRA) on 14 November 2022.
The partner brings a tremendous track record of conducting clinical trials, from industry-leading clinical development services to pioneering in human challenge studies. The partner’s clinical trial platform can help accelerate drug and vaccine development in respiratory and infectious diseases. This makes them a crucial collaborator to SpectrumX as they work together to develop a trial protocol, which they will discuss with the MHRA at their Scientific Advisory Meeting.
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The start-up agreement follows another important step toward Phase 1b clinical trial readiness; SpectrumX recently announced it has shipped its SPC-069 drug substance to its manufacturing partner to begin the process of manufacturing the product for trials.
These steps are critical milestones to launching the Phase 1b clinical trial with healthy volunteers, currently planned to start in March 2023, subject to necessary regulatory and ethics committee approvals.
Damien Hancox, Chief Executive Officer of SpectrumX, said: “We are delighted to have signed this agreement. We couldn’t have chosen a better partner, given their impressive credentials and extensive history in conducting and executing trials, to help deliver our first clinical trial results. This is a crucial step towards advancing our drug candidate to market authorisation and fulfilling our mission to treat patients impacted by debilitating respiratory infections.”
