Samumed has successfully completed a Phase 1 clinical trial in healthy individuals to evaluating a potential therapy — a nebulized inhalation solution called SM04646 — that treats idiopathic pulmonary fibrosis (IPF).
The positive results support SM04646’s continued development into future studies.
The Australian study (ACTRN12615001349538) was an open-label Phase 1 trial evaluating the safety and tolerability of a single inhalation of SM04646 in 17 adult healthy subjects, aged 18 to 50 years. SM04646 was tested in four ascending doses in four different treatment groups to determine the maximum tolerated dose (or the limit before causing a strong cough response): 0.7 mg, 2.0 mg, 7.0 mg, and 20.0 mg.
This marked the first time SM04646 was given to humans, after showing promising results in cells and in animal models.
Results revealed no serious adverse events or dose-limiting toxicities in any of the treatment groups. Treatment with SM04646 appeared to be safe and well tolerated by all participants enrolled in the study.
In the presentation, SM04646 was shown to have greater anti-fibrotic anti-fibrotic activity in vitro than either Esbriet (pirfenidone) or Ofev (nintedanib) — two approved therapies for IPF — in both normal and IPF-diseased human lung cells.
Additional details from the trial’s results, including information on how the body absorbs, distributes and eliminates SM04646 (the drug’s pharmacokinetics), will be released in upcoming medical conferences, according to a Samumed press release.
Recently, a comparison study featured in the journal Pharmacometrics & Systems Pharmacology found that the first two approved therapies for IPF, Esbriet and Ofev, are still the most reliable treatments among the current approved and experimental treatments available.
In the study, “Model-based Meta-Analysis on the Efficacy of Pharmacological Treatments for Idiopathic Pulmonary Fibrosis,” researchers from Bristol-Myers Squibb in collaboration with Quantitative Solutions used a model-based meta-analysis to create a database of combined clinical trial data to assess the effectiveness of different IPF therapies.