dutogliptin (PHX1149T) / Phenomix Corp, Recardio - LARVOL DELTA

Draft genome sequence data of Fusarium verticillioides strain REC01, a phytopathogen isolated from a Peruvian maize. (PubMed, Data Brief) - "De novo assembly from Illumina Novaseq 6000 sequencing yielded 456 contigs, which together constitute a 42.8 Mb genome assembly with a GC % content of 48.26. Subsequent comparative analyses were performed with other Fusarium genomes available in the NCBI database."

Journal

REC01 WELCOME NETWORKING EVENING (ESWI 2023) - No abstract available

HEAL-MI: Dutogliptin in Co-administration With Filgrastim in Early Recovery Post-myocardial Infarction (clinicaltrials.gov) - P3 | N=4100 | Not yet recruiting | Sponsor: Recardio, Inc.

New P3 trial • Cardiovascular • Congestive Heart Failure • Myocardial Infarction

Dutogliptin in Combination with Filgrastim in Early Recovery Post-Myocardial Infarction-The REC-DUT-002 Trial. (PubMed, J Clin Med) - "Concomitant treatment was well tolerated, and no safety issues were detected. Based on the results, the FDA and EMA have already approved an adequately powered large outcome trial."

Combination therapy • Journal • Cardiovascular • Congestive Heart Failure • Heart Failure • Infectious Disease • Myocardial Infarction • Novel Coronavirus Disease • Respiratory Diseases

Dietary Flavonoids with Catechol Moiety Inhibit Anticancer Action of Bortezomib: What about the other Boronic Acid-Based Drugs? (PubMed, Curr Cancer Drug Targets) - "As a result, another boronic acid moiety-harboring medication, ixazomib, was approved in 2015 as a second-generation proteasome inhibitor for multiple myeloma; and dutogliptin is under clinical investigation in combination therapy against myocardial infarction. Therefore, in parallel with the intensified development of boronic acid-based drugs, their possible interactions with catechol groups of plant-derived flavonoids must also be clarified to provide dietary recommendations to patients for maximizing therapeutic benefits. If concurrently consumed flavonoids can indeed antagonize drug efficacy, it may pose a real risk to clinical outcomes."

Journal • Cardiovascular • Hematological Malignancies • Multiple Myeloma • Myocardial Infarction • Oncology

Study of Dutogliptin in Combination With Filgrastim in Post-Myocardial Infarction (clinicaltrials.gov) - P2; N=49; Completed; Sponsor: Recardio, Inc.; Enrolling by invitation ➔ Completed; N=140 ➔ 49; Trial completion date: Oct 2021 ➔ Feb 2021; Trial primary completion date: Oct 2021 ➔ Feb 2021

Clinical • Combination therapy • Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Cardiovascular • Myocardial Infarction • Myocardial Ischemia

Study of Dutogliptin in Combination With Filgrastim in Post-Myocardial Infarction (clinicaltrials.gov) - P2; N=140; Enrolling by invitation; Sponsor: Recardio, Inc.; Trial completion date: Oct 2020 ➔ Oct 2021; Trial primary completion date: Oct 2020 ➔ Oct 2021

Clinical • Combination therapy • Trial completion date • Trial primary completion date • Cardiovascular • Myocardial Infarction • Myocardial Ischemia

"Protocol for a phase 2, randomized, double-blind, placebo-controlled, safety and efficacy study of dutogliptin in combination with filgrastim in early recovery post-myocardial infarction": study protocol for a randomized controlled trial. (PubMed, Trials) - P2 | "The REC-DUT-002 trial is the first to evaluate dutogliptin in combination with G-CSF in patients with STEMI. Results will lay the foundation for an appropriately powered cardiovascular outcome trial to test the efficacy of this combined pharmacological strategy."

Clinical • Combination therapy • Journal • P2 data • Cardiovascular • Myocardial Infarction

[VIRTUAL] Randomized, double blind, placebo-controlled, safety and efficacy study of dutogliptin in combination with filgrastim in early recovery post-MI: rationale, design and first interim analysis (ESC 2020) - "Our data demonstrate that the combined application of dutogliptin and G-CSF appears to be safe on the short term and feasible after acute myocardial infarction and may represent a new therapeutic option in future."

Clinical • Combination therapy • Cardiovascular • Myocardial Infarction • CXCL12

Study of Dutogliptin in Combination With Filgrastim in Post-Myocardial Infarction (clinicaltrials.gov) - P2; N=140; Recruiting; Sponsor: Recardio, Inc.; Not yet recruiting ➔ Recruiting

Enrollment open • Acute Coronary Syndrome • Biosimilar • Dyslipidemia • Gene Therapies • Reperfusion Injury

Safety and efficacy study of dutogliptin in subjects with type 2 diabetes mellitus on a background medication of metformin (clinicaltrials.gov) - Phenomix & Forest / P3, N=650

Diabetes

Safety and efficacy of dutogliptin in patients with type 2 diabetes mellitus (T2DM) on background therapy with pioglitazone (clinicaltrials.gov) - Forest & Phenomix / P3, N=400

Diabetes

Evaluation of the pharmacokinetics and pharmacodynamics of subcutaneously administered dutogliptin for daily injection with granulocyte colony stimulating factor (G-CSF) for AMI (ESC 2018) - "A novel s.c. formulation of dutogliptin was demonstrated to be well tolerated following single and multiple daily administration in healthy volunteers. Dutogliptin is readily bioavailable and sustained plasma DPP-IV inhibition was achieved with increasing s.c. doses. A global, multicenter Phase 2 study to demonstrate safety and efficacy of dutogliptin in combination with G-CSF in AMI will begin in early 2018."

PK/PD data • Biosimilar • Cardiovascular • Gene Therapies • Genetic Disorders • Reperfusion Injury

Study of Dutogliptin in Combination With Filgrastim in Post-Myocardial Infarction (clinicaltrials.gov) - P2; N=140; Enrolling by invitation; Sponsor: Recardio, Inc.; Trial completion date: Mar 2020 ➔ Oct 2020; Trial primary completion date: Dec 2019 ➔ Oct 2020

Clinical • Combination therapy • Trial completion date • Trial primary completion date

Safety, tolerability, pharmacokinetics and pharmacodynamics of parenterally administered dutogliptin: a prospective dose-escalating trial. (PubMed, Br J Clin Pharmacol) - "Parenteral injection of dutogliptin was safe and subcutaneous bioavailability is excellent. DPP-IV inhibition increased dose dependently to >86% over 24 hours after multiple doses of 120mg dutogliptin."

Clinical • Journal • PK/PD data