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

Boron-Containing Drug Candidates in Clinical Trials. (PubMed, Handb Exp Pharmacol) - "The agents reviewed include borofalan, delanzomib, flovagatran, dutogliptin, talabostat, numidargistat, OATD-02, AN0128, epetraborole, ganfeborole, acoziborole, taniborbactam, xeruborbactam, and sodium borocaptate, as well as the five FDA-approved boroncontaining drugs (bortezomib, ixazomib, crisaborole, tavaborole, vaborbactam). The review also highlights how clinical success depends on matching pharmacology with unmet need, feasible administration, competitive differentiation, and durable development partnerships. Ongoing advances in scaffold design, delivery, combination therapy, and indication selection are expected to broaden the therapeutic impact of boron-containing medicines."

Journal • Cardiovascular • Head and Neck Cancer • Hematological Disorders • Infectious Disease • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor • Thrombosis • Tuberculosis

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