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June 10, 2020updated 12 Jul 2022 11:45am

Immunic gets FDA clearance for CALVID-1 trial in Covid-19 patients

Biopharmaceutical company Immunic has secured US Food and Drug Administration (FDA) clearance to conduct its Phase II CALVID-1 clinical trial of IMU-838 for treating Covid-19 patients in the US.

Biopharmaceutical company Immunic has secured US Food and Drug Administration (FDA) clearance to conduct its Phase II CALVID-1 clinical trial of IMU-838 for treating Covid-19 patients in the US.

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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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IMU-838 is an oral, selective immune modulator designed to block the intracellular metabolism of activated immune cells by inhibiting the dihydroorotate dehydrogenase (DHODH) enzyme.

The drug candidate targets activated T and B cells. IMU-838 is currently in Phase II trials to treat patients with relapsing-remitting multiple sclerosis and ulcerative colitis.

IMU-838 has so far been investigated in approximately 650 individuals and demonstrated a favourable pharmacokinetic, safety and tolerability profile.

In addition, the drug candidate is being assessed as a potential Covid-19 treatment. DHODH inhibitors, such as IMU-838, are considered to exhibit a host-based antiviral effect.

The Phase II trial for Covid-19 patients obtained regulatory allowance from the German health authority, BfArM, on 13 May this year, followed by clearance in other European countries.

CALVID-1 is a prospective, multi-centre, randomised, placebo-controlled, double-blind clinical trial for about 230 patients suffering from moderate Covid-19. It is designed to assess the safety, efficacy and tolerability of IMU-838.

The aim of the study is to test the ability of the drug candidate to improve symptoms, prevent worsening and the need for further treatments, such as ventilation and lower virus number when given along with doctor’s choice of standard therapy.

The primary outcome measure of the CALVID-1 trial is the proportion of patients without any requirement for INV during the study duration, while secondary outcomes include duration of ICU treatment and hospitalisation and 28-day all-cause mortality.

Top-line results from the study are expected to be available later this year, with the trial estimated to be completed in October.

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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
by Suvoda
Enter your details here to receive your free Case Study.

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