Idiopathic pulmonary fibrosis digest - 2021

Idiopathic pulmonary fibrosis digest - 2021

Early result of Daewoong’s DWN12088 in idiopathic pulmonary fibrosis

DWN12088 (PRS-inhibitor) – Daewoong Pharmaceutical

  • Trial details: ACTRN12619001239156; Phase 1 in healthy volunteers; N= 80; Cohort 1: single-ascending dose test (SAD): DWN12088 100-800 mg PO; Cohort 2: multiple- ascending dose test (MAD): DWN12088 25-300 mg PO; Primary outcomes: Safety and tolerability; Recruiting; Location: Australia
  • Results:
    • Oral administration of DWN12088 demonstrated safety with no serious adverse event (SAE) in single and multiple ascending dose studies
    • The most common TEAE: GI disorders
    • DWN12088 pharmacokinetic profiles showed dose linearity and plasma DWN12088 exposures were increased dose-dependently across the single and multiple doses
    • The study showed dose-dependent reduction of Type 3 Procollagen Peptide (P3NP), which suggests DWN12088 may be able to show anti-fibrotic efficacy by successfully down-regulating collagen synthesis in IPF patients
  • When combined with either Pirfenidone or Nintedanib, DWN12088 exhibits a synergistic anti-fibrotic effect in both in vitro and in vivo IPF models (For full story click here)

A multi-national Phase 2 clinical trial with DWN12088 is expected to begin by the end 2021

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CI Scientists Commentary:

  • Aimed at establishing superiority compared to Esbriet (pirfenidone, Genentech) and Ofev (Nintedanib, Boehringer)), Daewoong’s DWN12088 fares well in a Phase 1 study in healthy volunteers
  • Daewoong established treatment dosage and confirmed the potential as a treatment for IPF
  • They are planning to apply for IND Phase 2 in 2021
  • With preclinical studies showing synergistic anti-fibrotic effect in combination with Pirfenidone or Nintedanib, Daewoong may plan to conduct studies investigating DWN12088 monotherapy and in combination with other anti-fibrotic agents
  • In 2019, FDA granted Orphan drug designation for DWN12088 in IPF

– Dr. Kowndinya, CI Scientists

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