- Results support ongoing Phase 2 ELEVATE 1 study in pulmonary arterial hypertension
CARY, N.C. and BASEL, Switzerland, Oct. 1, 2019 /PRNewswire/ -- Altavant Sciences, a clinical-stage biopharmaceutical company focused on patient-centric drug development in rare respiratory diseases, today announced new clinical data from two Phase 1 trials of rodatristat ethyl, demonstrating favorable safety and tolerability in healthy volunteers, and mechanistic biomarker data consistent with efficacy in nonclinical models of pulmonary arterial hypertension (PAH). These data were presented in a poster presentation, titled "Safety, tolerability, pharmacokinetics and pharmacodynamics after repeated once or twice daily RVT-1201, a TPH inhibitor for treatment of PAH", at the 29th International Congress of the European Respiratory Society (ERS). Rodatristat ethyl, Altavant's lead product candidate, is a tryptophan hydroxylase (TPH) inhibitor being evaluated for the treatment of patients with PAH.
Two Phase 1 single-center, multiple ascending dose trials were conducted in 96 healthy subjects who received multiple daily doses of rodatristat ethyl (n=72) or placebo (n=24) for 14 days. No serious adverse events (AEs) or dose-limiting toxicities were observed in the study. The most common AEs across all RVT-1201 multiple dose treatment groups were nausea (n=13), diarrhea (n=10) and headache (n=7), and all were generally mild and dose-related (one incidence of diarrhea was considered moderate). Pharmacokinetics were dose proportional and correlated to reductions in serotonin biosynthesis that exceeded those required for efficacy in nonclinical models of PAH. Altavant is currently evaluating rodatristat ethyl in its ongoing ELEVATE 1 proof-of-concept Phase 2a trial in patients with PAH.
"A disease-modifying treatment option for PAH would represent a crucial advance in patient care," said William T. Symonds, Pharm.D., Chief Executive Officer of Altavant. "The results presented at ERS indicate that we can maintain a favorable safety profile while pursuing this potentially disease-modifying treatment for PAH. We are actively recruiting patients with PAH in a proof-of-concept Phase 2a study of our lead candidate, rodatristat ethyl, which we hope will demonstrate changes in biomarkers of serotonin biosynthesis consistent with those associated with improvements to vessel remodeling in animal models of PAH."
About Rodatristat Ethyl
Rodatristat ethyl is a tryptophan hydroxylase (TPH) inhibitor designed to reduce the body's peripheral production of serotonin. An established body of scientific evidence supports dysregulated peripheral serotonin production as a trigger of aberrant proliferation of the smooth muscle cells and constriction in the wall of the pulmonary arteries, causing them to restrict blood flow in pulmonary arterial hypertension (PAH). By lowering circulating serotonin levels, it is believed that rodatristat ethyl may halt or reverse the pathology of diseases that are driven by excessive serotonin production, such as PAH, idiopathic pulmonary fibrosis (IPF) and sarcoidosis. Altavant is currently testing this mechanism of action in the ELEVATE 1 proof-of-concept Phase 2a study of rodatristat ethyl in patients with PAH.
About Altavant Sciences
Altavant Sciences is a clinical-stage biopharmaceutical company focused on elevating patient-centric drug development in rare respiratory diseases with an initial focus on pulmonary arterial hypertension (PAH). Altavant's lead candidate, rodatristat ethyl, is a tryptophan hydroxylase (TPH) Inhibitor that reduces the body's peripheral production of serotonin, thereby lowering circulating serotonin levels in diseases where excessive production of the hormone has been implicated in pathogenesis - including PAH, certain types of cancer, GI disorders, fibrosis and inflammation. Rodatristat ethyl is currently being investigated in the ELEVATE 1 Phase 2 Study in patients with PAH. For more information, please visit www.altavant.com.
About Roivant Pharma
Roivant Pharma is the biopharmaceutical business unit of Roivant Sciences. Roivant Pharma is focused on end-to-end biopharmaceutical company creation, launch, and oversight. Roivant Pharma companies include Altavant, Aruvant, Axovant, Dermavant, Enzyvant, Genevant, Immunovant, Metavant, Myovant, Respivant, Urovant, and Arbutus.
About Roivant Sciences
Roivant aims to improve health by rapidly delivering innovative medicines and technologies to patients. Roivant does this by building Vants – nimble, entrepreneurial biotech and healthcare technology companies with a unique approach to sourcing talent, aligning incentives, and deploying technology to drive greater efficiency in R&D and commercialization. For more information, please visit www.roivant.com.
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