Altavant Sciences Initiates Phase 2a Study of Rodatristat Ethyl in Pulmonary Arterial Hypertension
- Category: Small Molecules
- Published on Monday, 05 August 2019 19:30
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CARY, NC, USA and BASEL, Switzerland I August 5, 2019 I Altavant Sciences, a clinical-stage biopharmaceutical company focused on patient-centric drug development in rare respiratory diseases, announced that it has dosed the first patient in the ELEVATE 1 proof-of-concept Phase 2a study of the company's lead candidate, rodatristat ethyl, in patients with pulmonary arterial hypertension (PAH). The study is designed to provide valuable safety, target engagement and biomarker information, which will be used to inform a comprehensive Phase 2b efficacy study of rodatristat ethyl in PAH.
"Initiating the ELEVATE 1 Study is a significant milestone for Altavant, and represents our commitment to the rare respiratory disease community and our approach to patient-centric, transparent clinical development," said William T. Symonds, Pharm.D., Chief Executive Officer of Altavant. "Rodatristat ethyl is a first-in-class investigational medicine for the treatment of PAH. Our goal for ELEVATE 1 is to establish proof-of-concept for this new mechanism in PAH, which we believe could halt or reverse the pulmonary vascular remodeling characteristic of the disease. Success in this study would take us one step closer to being able to provide a much-needed, new therapeutic option to PAH patients."
Marc Humbert, M.D., Ph.D., Professor of Respiratory Medicine at the South Paris University (Université Paris-Saclay), Director of the French Pulmonary Hypertension Reference Center, and member of Altavant's Scientific Advisory Board, added, "While the introduction of vasodilators was a significant advancement in treating PAH, having improved exercise capacity, hemodynamics and quality of life for countless patients, there is still a need to develop novel treatment options to further improve lifespan. New R&D efforts, such as those pursued at Altavant, may ultimately give us an opportunity to offer a new treatment option to PAH patients that provides better outcomes. I'm excited to help further that R&D effort and elevate the conversation about PAH and the need for new therapies within the medical community."
About the ELEVATE 1 Study
ELEVATE 1 is a double-blind, placebo-controlled, multicenter study to determine the safety, tolerability, pharmacokinetics (PK) and biomarker pharmacodynamics of rodatristat ethyl in adults with PAH. Approximately 36 adults with PAH will be enrolled in ELEVATE 1. Rodatristat ethyl's unique and complementary mechanism of action relative to available medications allows PAH patients currently taking vasodilators to be eligible for enrollment. Eligible patients will be randomized 2:1 to receive rodatristat ethyl or placebo twice daily for six weeks. Each patient will be assessed for primary and secondary endpoints of safety and PK. In addition, ELEVATE 1 will evaluate the effect of rodatristat ethyl on biomarkers of target engagement and on several exploratory efficacy measures, including exercise capacity, breathlessness and World Health Organization (WHO) functional class. For more information on ELEVATE 1, please visit www.ElevatePAHStudy.com.
About Rodatristat Ethyl
Rodatristat ethyl is a tryptophan hydroxylase (TPH) Inhibitor designed to reduce the body's peripheral production of serotonin. A significant body of scientific evidence supports dysregulated peripheral serotonin production as a trigger of aberrant proliferation and constriction of the smooth muscle cells in the wall of the pulmonary arteries, causing them to restrict blood flow in 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.
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.
SOURCE: Altavant Sciences