Hepion's CRV431 Shows Encouraging Safety Profile In Drug-Drug Interaction Study

  • Hepion Pharmaceuticals Inc HEPA has announced results from a Drug-Drug Interaction (DDI) study with its lead drug candidate, CRV431.
  • CRV431 targets several isoforms of cyclophilins which comprise a family of enzymes involved in collagen production, inflammation, cell injury, cell death, and protein folding. 
  • The open-label DDI study was conducted in healthy volunteers (n = 24) to determine if single or multiple oral doses of ketoconazole (400 mg) influence the pharmacokinetics of CRV431 (75 mg). 
  • The study also examined if CRV431 affected the PK of midazolam (2 mg IV) and its metabolite, 1-hydroxymethyl midazolam. 
  • Following five daily oral doses of ketoconazole, the maximum blood concentration of CRV431 increased approximately five-fold, while the exposure increased almost four-fold. 
  • When CRV431 was dosed with midazolam, the exposures of midazolam and 1-hydroxymethyl midazolam did not alter significantly.
  • However, both the Cmax and AUC0-24 of CRV431 were increased by approximately two-fold.
  • Related Link: Hepion Pharma's NASH Candidate Aces Mid-Stage Study.
  • Price Action: HEPA stock is up 0.97% at $1.57 during the market session on the last check Wednesday.
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