erythropoietin long acting (LP-001) / Longbio Pharma - LARVOL DELTA

LP-001, a Novel Long-Acting EPO-Fc Fusion Protein: A Phase I Dose-Escalation Study of Pharmacokinetics, Safety, and Tolerability in Healthy Chinese Subjects. (PubMed, Clin Pharmacol Drug Dev) - "LP001, a long-acting rhEPO, was safe and well-tolerated at all doses in this Phase I study. These findings support its continued development as a treatment for myelodysplastic syndromes (MDS)."

Clinical • Journal • P1 data • PK/PD data • Hematological Malignancies • Hypertriglyceridemia • Myelodysplastic Syndrome • Oncology

A Study of Single and Multiple Dose Administration of LP-001 in Healthy Subjects (clinicaltrials.gov) - P1 | N=68 | Completed | Sponsor: Longbio Pharma | Active, not recruiting ➔ Completed

Trial completion • Hematological Malignancies • Myelodysplastic Syndrome • Oncology

LP-001, A NOVEL LONG-ACTING EPO OF MOST COSTEFFECTIVE IN CKD ANEMIA (ISN-WCN 2024) - " LP-001 has a bioactivity comparable to Aranesp in both cell based assay (UT-7) and in-vivo animal models (normal SD rats, carboplatin induced anemia in SD rats and with cyclophosphamide induced anemia in cynomolgus monkey... The pre-clinical and phase I study of LP-001 suggests that this novel long-acting EPO has a comparable glycosylation form and half-life to Aranesp. Moreover, it can improve the EPO level more smoothly therefore renders a potential safer and cost-effective ESA that might be alternative for CKD treatment."

Cost effectiveness • HEOR • Anemia • Chronic Kidney Disease • Fatigue • Hematological Disorders • Nephrology • Renal Disease

A Study of Single and Multiple Dose Administration of LP-001 in Healthy Subjects (clinicaltrials.gov) - P1 | N=68 | Active, not recruiting | Sponsor: Longbio Pharma

New P1 trial • Hematological Malignancies • Myelodysplastic Syndrome • Oncology