Data from Spyryx Biosciences' HOPE-1 Phase 2 Clinical Trial to be Presented in a Late-Breaking O
DURHAM, N.C., May 8, 2018 /PRNewswire/ -- Spyryx Biosciences, Inc., a clinical-stage biopharmaceutical company developing novel therapeutics for severe pulmonary diseases, will present data from the first cohort of its ongoing Phase 2 clinical trial, HOPE-1, in a late-breaking oral presentation at the 41st European Cystic Fibrosis Conference. The data will be presented by Isabelle Fajac, M.D., Ph.D., Principal Investigator, Vice President and President Elect of the European Cystic Fibrosis Society, on June 8 during the conference in Belgrade, Serbia.
HOPE-1 (Hydration for Optimal Pulmonary Effectiveness) is a randomized, controlled, 28-day Phase 2 study of Spyryx's lead therapeutic candidate, SPX-101, for treatment of cystic fibrosis (CF). The study uses an adaptive design that, in the first completed cohort, tested two doses of SPX-101 against placebo. In total, the study is planned to enroll approximately 90 adult subjects with CF and is being conducted in Canada and Western Europe. The adaptive trial design allows for efficient testing of the efficacy, safety, and tolerability of SPX-101 across multiple dose levels.
"We are grateful to the many patients who gave so much of their valuable time to participate in this landmark clinical trial," said Alistair Wheeler, M.D., Chief Medical Officer of Spyryx Biosciences. "Life with cystic fibrosis means many hours spent on treatments every day, and dedicating time to a clinical trial significantly increases that burden. We are also grateful to the clinical teams in our trial centers for their dedication to this program."
"We are excited that the very encouraging data from 46 patients in Cohort 1 have been accepted as a late-breaking oral presentation at the upcoming ECFS meeting, and are poised to continue to advance the program in development with Cohort 2 in the coming weeks," said Tim Shannon, M.D., Chairman of the Board at Spyryx Biosciences and General Partner at Canaan.
Added Robert Tarran, Ph.D., Spyryx Founder and University of North Carolina Faculty Member, "SPX-101 was designed as an inhaled peptide with a novel mechanism for internalizing epithelial sodium channels (ENaCs) from the mucosal surface of the airway. The drug is intended to promote airway hydration and mucociliary clearance, which are dysfunctional in CF. The mechanism of action of SPX-101 is independent of the genetic mutations that cause CF, which makes it a potential therapy for all those living with CF."
About Spyryx Biosciences
Spyryx Biosciences is a clinical-stage biopharmaceutical company developing innovative therapeutics to address severe pulmonary diseases. Spyryx's lead clinical candidate, SPX-101, is completing a multinational Phase 2 study as a novel treatment for cystic fibrosis. The product has demonstrated a robust ability to restore mucociliary clearance in animal models of the disease. SPX-101 has also been shown to be safe and well tolerated in a completed Phase 1b in adult patients with cystic fibrosis and has the potential to improve lung function in all people living with cystic fibrosis independent of their genotype. Spyryx is funded by a first-tier syndicate of life science investors, including Canaan Partners, 5AM Ventures and Hatteras Venture Partners. Further information regarding Spyryx Biosciences is available at www.spyryxbio.com.
SOURCE Spyryx Biosciences, Inc.