35Pharma Announces Clearance of Clinical Trial Application for HS135, Best-in-Class Activin and GDF Inhibitor

  • Phase 1 healthy volunteer study will evaluate HS135 safety, pharmacokinetics and biomarker responses
  • HS135 is a highly potent receptor ectodomain trap that neutralizes Activins and GDFs, validated drivers of Pulmonary Hypertension, obesity and cardiometabolic diseases
  • Dosing is expected to begin in early 2024

Montréal, QC, Canada (Jan 03, 2024) – 35Pharma, a clinical-stage biopharmaceutical company that designs and develops TGF-beta superfamily therapeutics, today announced it received a No Objection Letter from Health Canada for its Clinical Trial Application to initiate HS135-001, a Phase 1 study of HS135 in healthy volunteers. 

“Overactive Activin and GDF signalling is a genetically and clinically validated driver of Pulmonary Hypertension, obesity and cardiometabolic diseases. 35Pharma developed a portfolio of differentiated agents targeting this rich biology with HS135 being the first to enter clinical testing.” said Ilia Tikhomirov, 35Pharma’s CEO. “HS135 neutralizes Activins and GDFs with best-in-class potency which we expect to translate into superior activity in patients. We will be sharing initial data on safety and biological activity during 2024.”

HS135-001 is a Phase 1, single-center, double-blind, randomized, placebo-controlled clinical trial in healthy postmenopausal women. Key readouts of the study include safety, pharmacokinetics and change in biomarkers related to Activin and GDF biology following subcutaneous administration of HS135. Dosing is expected to begin in early 2024.

About 35Pharma 
35Pharma is a clinical-stage biopharmaceutical company focussed on the design and development of best-in-class transforming growth factor-beta (TGF-beta) superfamily ligand traps for Pulmonary Hypertension, obesity and cardiometabolic diseases. 35Pharma leverages its scientific leadership in TGF-beta biology combined with superior protein engineering to discover innovative compounds that selectively and potently neutralize validated pathological TGF-beta ligands while sparing beneficial homeostatic ligands.