KP-001 / Kaken Pharma - LARVOL DELTA

Therapeutic and immunomodulatory effects of phage therapy in red hybrid tilapia challenged with Klebsiella pneumoniae. (PubMed, Arch Microbiol) - "This study evaluated the therapeutic efficacy and immunomodulatory effects of Klebsiella pneumoniae Phage 5 (KPP5) in red hybrid tilapia experimentally challenged with K. pneumoniae strain 001 (KP001)...Overall, this study supports the potential of bacteriophage therapy as a safe and promising alternative strategy for managing antibiotic-resistant bacterial infections in aquaculture. This study was registered with the Institutional Animal Care and Use Committee (IACUC) of Universiti Malaya (Ref: G8/10032025/07012025-02/R)."

Journal • Infectious Disease • Inflammation • Pneumonia

The Pharmacokinetics of a Novel Inhaled Epinephrine (AAAAI 2026) - "Rationale KP001 is a proprietary epinephrine inhaler being developed for the treatment of Type 1 allergic reactions, including anaphylaxis. The authors wish to thank the participation of Dr. Francoeur at Syneos Health (Quebec City) and Dacima biostatistics teams for their contributions."

First-in-human • Late-breaking abstract • PK/PD data • Hematological Disorders • Inflammation • Respiratory Diseases

A Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of KP-001 (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: Kaken Pharmaceutical | Not yet recruiting ➔ Completed

Trial completion • Hepatology

A Study to Evaluate the Effects of KP-001 on the QT/QTc Intervals in Healthy Adults (clinicaltrials.gov) - P1 | N=40 | Completed | Sponsor: Kaken Pharmaceutical | Active, not recruiting ➔ Completed

Trial completion

Phase 1 Crossover Study Evaluating the Safety, Tolerability, and Pharmacokinetics of KP001 in Healthy Adult Volunteers (clinicaltrials.gov) - P1 | N=16 | Completed | Sponsor: Kokua Pharma Inc. | Recruiting ➔ Completed

Trial completion • Allergy

Phase 1 Crossover Study Evaluating the Safety, Tolerability, and Pharmacokinetics of KP001 in Healthy Adult Volunteers (clinicaltrials.gov) - P1 | N=16 | Recruiting | Sponsor: Kokua Pharma Inc.

New P1 trial • Allergy

AccurEdit Therapeutics’ LNP-based In Vivo Gene Editing Product ART001 Obtained Orphan Drug Designation from the FDA (PRNewswire) - "AccurEdit Therapeutics today announced that its innovative in vivo gene editing product, ART001, has obtained Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration...ART001, which utilizes lipid nanoparticle (LNP) technology for targeted gene editing, is designed for the treatment of transthyretin amyloidosis (ATTR), a rare and life-threatening disease. It is currently the first and only LNP-based in vivo gene editing product worldwide that has cleared an IND in both China and the United States. It was also China's first LNP-based in vivo gene editing product to enter clinical study in human in August 2023. Clinical data shows that a single dose of ART001 can achieve a >90% reduction of transthyretin (TTR) in the serum."

Orphan drug • Amyloidosis • Cardiovascular

A Study to Determine the Effect of KP-001 on Metformin and Midazolam Pharmacokinetics and the Effect of Clarithromycin on KP-001 Pharmacokinetics in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=38 | Completed | Sponsor: Kaken Pharmaceutical | Active, not recruiting ➔ Completed

Trial completion

A Study to Evaluate the Effects of KP-001 on the QT/QTc Intervals in Healthy Adults (clinicaltrials.gov) - P1 | N=40 | Active, not recruiting | Sponsor: Kaken Pharmaceutical | Recruiting ➔ Active, not recruiting

Enrollment closed

A Study to Determine the Effect of KP-001 on Rosuvastatin and Caffeine Pharmacokinetics and the Effect of Fluvoxamine on KP-001 Pharmacokinetics in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=36 | Not yet recruiting | Sponsor: Kaken Pharmaceutical

New P1 trial

A Study to Evaluate the Effects of KP-001 on the QT/QTc Intervals in Healthy Adults (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: Kaken Pharmaceutical

New P1 trial