modimelanotide (ABT-719) / Zealand Pharma, AbbVie - LARVOL DELTA

A Safety and Efficacy Trial of Multiple Dosing Regimens of ABT-719 for the Prevention of Acute Kidney Injury in Subjects Undergoing High Risk Cardiac Surgery (clinicaltrials.gov) - P2b; N=240; Completed; Sponsor: AbbVie; Phase classification: P2 ➔ P2b

Clinical • Phase classification • Acute Kidney Injury • Cardiovascular • Nephrology • Renal Disease • CST3

A safety and efficacy trial of multiple dosing regimens of ABT-719 for the prevention of acute kidney injury in subjects undergoing high risk surgery (clinicaltrials.gov) - P2, N=160; Sponsor: AbbVie; Enrolling by invitation; New P2 trial.

New P2 trial • Renal Disease

Zealand Pharma: ADA 2013 (Zealand Pharma) - Anticipated initiation of second Phase IIb study in acute kidney injury in 2013

Anticipated new P2b trial • Renal Disease

Summary of supportive clinical data presented on Lyxumia and LixiLan at EASD, new large-scale Lyxumia observational study, INTENSE, initiated by Sanofi and other pipeline updates (GlobeNewswire) - "Zealand’s license partner, AbbVie, has decided to discontinue the development of ABT-719 (ZP1480) based on results from a Phase II study on its use to treat acute kidney injury associated with cardiac surgery and other indications. AbbVie’s decision has no financial impact on Zealand and the program has been removed from Zealand’s pipeline."

Discontinued • Acute Kidney Injury • Renal Disease

AbbVie profit beats analysts’ estimates in first quarter (Bloomberg.com) - "ABT-719...may enter the final phase of trials late next year..."

Anticipated new P3 trial • Renal Disease

A safety and efficacy trial of multiple dosing regimens of ABT-719 for the prevention of acute kidney injury in subjects undergoing high risk cardiac surgery (clinicaltrials.gov) - P2, N=240; Sponsor: AbbVie; Active, not recruiting; Primary completion date: Dec 2013 -> Mar 2014.

Trial primary completion date • Acute Kidney Injury • Renal Disease

A safety and efficacy trial of multiple dosing regimens of ABT-719 for the prevention of acute kidney injury in subjects undergoing high risk cardiac surgery (clinicaltrials.gov) - P2, N=240; Sponsor: AbbVie; Recruiting; Start date: Feb 2013 -> Jul 2012; Completion date: Sep 2013 -> Mar 2014; N=160 -> 240.

Enrollment change • Trial completion date • Trial initiation date • Renal Disease

A Safety and Efficacy Trial of Multiple Dosing Regimens of ABT-719 for the Prevention of Acute Kidney Injury in Subjects Undergoing High Risk Surgery (clinicaltrials.gov) - P2; N=160; Active, not recruiting; Sponsor: AbbVie; Trial completion date: Oct 2014 ->Feb 2015

Trial completion date • Acute Kidney Injury • Biosimilar • Renal Disease

Acute kidney injury: emerging pharmacotherapies in current clinical trials. (PubMed, Pediatr Nephrol) - "Here we review emerging pharmacotherapies for AKI that are currently in clinical trials. Categorized by their general mechanism of action, the therapies discussed include anti-inflammatory agents (recAP, AB103, ABT-719), antioxidants (iron chelators, heme arginate), vasodilators (levosimendan), apoptosis inhibitors (QPI-1002), and repair agents (THR-184, BB-3, mesenchymal stem cells)."

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