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  1. Suvoda WP
August 27, 2013updated 13 Jul 2022 10:57am

Congenia begins enrolling healthy volunteers in Phase I trial of GNX-5086

Clinical stage biopharmaceutical company Congenia has started healthy volunteer enrolment in Phase I trial of GNX-5086, a potent small molecule inhibitor of a novel target involved in modulating stress induced cell death mPTP.

Clinical stage biopharmaceutical company Congenia has started healthy volunteer enrolment in Phase I trial of GNX-5086, a potent small molecule inhibitor of a novel target involved in modulating stress induced cell death mPTP.

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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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Designed to assess the safety and tolerability and pharmacokinetics of single ascending doses of GNX-5086, the randomised, double-blind, placebo-controlled study is expected to enrol 33 healthy volunteers.

The company is developing GNX-5086 against cardiac reperfusion injury (RI) that contributes significantly to the morbidity and mortality subsequent tomyocardial infarction (MI), which has no existing therapies.

"GNX-5086 has the capability to increase the capacity of isolated mitochondria to retain calcium and consequently protect the mitochondria from calcium overload in stress situations."

Being developed for intravenous administration to infarcted patients just prior to percutaneous coronary intervention (PCI), GNX-5086 has the capability to increase the capacity of isolated mitochondria to retain calcium and consequently protect the mitochondria from calcium overload in stress situations.

Through a longstanding preclinical collaboration with the Drug Discovery Program of the European Institute of Oncology (DDP-IEO), GNX-5086 was selected as lead compound.

The effectiveness of GNX-5086 in attenuating RI and reducing infarct size was demonstrated in in-vivo studies using a rabbit model of acute myocardial infarction when administered just prior to heart reperfusion.

The company filed a clinical trial application (CTA) to begin the Phase I study of GNX-5086 on 4 July in the Netherlands and won approval by the local regulatory authorities on 24th of the same month.

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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
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