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April 29, 2021updated 12 Jul 2022 11:18am

Innovation Pharma completes 50% enrolment in Covid-19 drug trial

Innovation Pharmaceuticals has enrolled more than 50% of the total targeted number of subjects in Phase II clinical trial of Brilacidin to treat moderate-to-severe Covid-19 in hospitalised patients.

Innovation Pharmaceuticals has enrolled more than 50% of the total targeted number of subjects in Phase II clinical trial of Brilacidin to treat moderate-to-severe Covid-19 in hospitalised patients.

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A non-peptidic defensin-mimetic drug candidate, Brilacidin has demonstrated potent inhibition in vitro against various coronavirus and alphavirus strains, indicating its potential as a broad-spectrum antiviral.

The randomised, double-blind, placebo-controlled, parallel-group design trial plans to enrol a total of 120 participants with moderate to severe Covid-19 who are hospitalised with respiratory distress but do not need high-level respiratory support.

The trial subjects will be randomised to receive intravenous dose of Brilacidin or placebo for three days to five days, in addition to Standard of Care in both arms.

Innovation Pharmaceuticals CEO Leo Ehrlich said: “Achieving over 50% trial enrolment represents an important milestone as we advance Brilacidin for treatment of Covid-19.

“We are hopeful Brilacidin will emerge not only as an effective Covid-19 therapeutic, but also as a desperately needed broad-spectrum antiviral.

“With the world experiencing a record number of new Covid-19 cases, including nearly one million new infections in India across a three-day period, we remain dedicated to bringing to market a novel antiviral to help ease patient suffering.”

The company is developing the drug for Covid-19 treatment under Fast Track designation from the US Food and Drug Administration (FDA).

On concluding a scheduled review of interim safety data from the trial, an independent Data Monitoring Committee recently recommended an increase in the dosing regimen of Brilacidin from three days to five days.

The five-day regimen could potentially boost the therapeutic benefits and offer a comparison with five-day Veklury (remdesivir), an FDA-approved Covid-19 treatment.

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Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
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