Spyryx Biosciences has announced the initiation of the Phase 2 HOPE-1 study of SPX-101, an inhaled SPLUNC1-derived peptide, in cystic fibrosis patients. The 28-day study is designed to enroll as many as 78 CF patients and will compare two doses of SPX-101 against a placebo.
In June 2017, Spyryx announced an increase in an award from Cystic Fibrosis Foundation Therapeutics (CFFT) for development of SPX-101 up to $5 million and said that it planned to use the additional funds for HOPE-1. Positive results from a Phase 1 study of SPX-101 were announced in February 2017.
Spyryx Chief Medical Officer Alistair Wheeler said, “We are delighted to have treated the first patient in our Phase 2 study of SPX-101. This study will provide data relating to efficacy and safety at the earliest opportunity. We are particularly proud that patients who were part of the protocol review process have provided positive feedback, reflecting that we have kept the investment of their valuable time to a minimum. The study has also been embraced by many widely respected researchers in the CF clinical community and we are grateful for their engagement.”
Read the Spyryx Biosciences press release.