Altavant Sciences Reports Rodatristat Ethyl PK/PD Analysis at ATS Supporting Doses Selected for Phase 2b ELEVATE 2 Study

CARY, N.C. and BASEL, Switzerland, May 20, 2021 /PRNewswire/ -- Altavant Sciences, a clinical-stage biopharmaceutical company focused on patient-centric drug development in rare respiratory diseases, presented an update on the clinical development of rodatristat ethyl, the company's lead candidate for the treatment of pulmonary arterial hypertension (PAH), at the recent meeting of the American Thoracic Society (ATS). This update included findings from a dose-response model, which simulated daily administration of rodatristat ethyl to identify optimal doses for the Phase 2b clinical trial.

In a 28-day preclinical study, a 40% reduction in serotonin biosynthesis significantly improved vascular remodeling and pulmonary vascular resistance in animal models of PAH. Altavant developed a dose-response model that accounted for variabilities in drug exposure and drug response observed in previous clinical studies. After conducting 10,000 simulations, doses of 300mg and 600mg BID were identified as having a high probability of achieving the targeted 40% reduction in serotonin biosynthesis. The company is assessing these doses in PAH patients in the randomized, double-blind Phase 2b ELEVATE 2 (NCT04712669) study, which is now enrolling patients at sites in the US, and later this year in the EU, and Canada. The e-poster, A Pharmacokinetic / Pharmacodynamic-Based Rationale for Dose Selection of the TPH Inhibitor Rodatristat Ethyl in ELEVATE–2 - a Phase 2b Study in Pulmonary Arterial Hypertension can be found on Altavant's website.

Bill Symonds, Pharm.D., Chief Executive Officer of Altavant, explained, "In preparation for initiating ELEVATE 2, we conducted extensive nonclinical and clinical research on the pharmacokinetics and pharmacodynamics of rodatristat ethyl. As we reported at ATS in 2020, we performed nonclinical studies to assess the drug candidate's penetration into lung tissue as well as exposure in the periphery and central nervous system; the latter was performed to ensure that brain levels of serotonin are preserved. Now that we have identified the optimal dose levels, we are excited to begin enrolling patients into the ELEVATE 2 study."

ELEVATE 2 will test the ability of rodatristat to reduce the peripheral production of serotonin through its unique mechanism of tryptophan hydroxylase (TPH) inhibition in order to improve PAH symptoms. The pathology underlying PAH appears to be driven, in part, by the unchecked production of peripheral serotonin, which drives the proliferation and constriction of the smooth muscle cells in the wall of the pulmonary arteries that is a hallmark of the disease.

Clinicians and others interested in learning more about rodatristat's unique mechanism of action are encouraged to watch the archived video symposium: Serotonin Pathobiology in Pulmonary Arterial Hypertension and Phase 2b Investigation of the Novel Therapy Rodatristat Ethyl (RE) in WHO Group 1 PAH. This event was hosted by Altavant on May 18, 2021 from 5:30 - 6:00 p.m. Eastern Time and featured a presentation by Marc Humbert, M.D., Ph.D., Director of the French Pulmonary Hypertension Referral Center & Professor of Respiratory Medicine at the Université Paris-Saclay.

In addition, Lyn Baranowski, Altavant's Chief Operating Officer gave a presentation focused on the company's patient-centered clinical development strategy, titled: Bench to Bedside: The Importance of the Patient Voice in the Drug Discovery Pipeline. Ms. Baranowski discussed several aspects of the company's approach, including: the use of advisory boards and one-on-one interviews to capture and address patient concerns, the development of patient-focused materials and trial summary reports, and partnerships with organizations like Greater Gift.

Pre-recorded presentations of the e-poster and the patient-centered clinical development strategy are available on demand on the ATS virtual platform until July 2, 2021, and all presentations are archived on the Altavant website in compliance with the congress' embargo policy.

About Altavant Sciences
Altavant Sciences is a clinical-stage biopharmaceutical company focused on elevating patient-centric drug development in rare respiratory diseases. Altavant is currently developing two pipeline candidates: rodatristat ethyl and ALTA-2530. Rodatristat is a tryptophan hydroxylase (TPH) inhibitor in Phase 2 development for patients with pulmonary arterial hypertension. By reducing serotonin production via TPH inhibition rodatristat may play a role in halting or reversing the vascular remodeling associated with PAH, offering a novel treatment option for patients living with this disease. ALTA-2530 is an inhaled interleukin-1 receptor antagonist under development for bronchiolitis obliterans syndrome (BOS), a life-threatening form of chronic lung allograft dysfunction (CLAD) that may present following lung transplantation. ALTA-2530's unique mechanism of action may offer a novel treatment option for patients who suffer from BOS, a disease where there are currently no approved therapies.

Altavant is a wholly owned subsidiary of Sumitovant Biopharma Ltd. For more information, please visit https://altavant.com. 

About Sumitovant Biopharma Ltd.
Sumitovant is a global biopharmaceutical company with offices in New York City and London. Sumitovant is a wholly owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd. Sumitovant is the majority shareholder of Myovant, and wholly owns Enzyvant, Spirovant, Urovant, and Altavant. Sumitovant's pipeline is comprised of early- through late-stage investigational medicines across a range of disease areas targeting high unmet need.

Sumitovant Biopharma Ltd. is a wholly owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd. For further information about Sumitovant please visit https://www.sumitovant.com/. 

About Sumitomo Dainippon Pharma Co., Ltd.
Sumitomo Dainippon Pharma is among the top-ten listed pharmaceutical companies in Japan, operating globally in major pharmaceutical markets, including Japan, the U.S., China and the European Union. Sumitomo Dainippon Pharma is based on the merger in 2005 between Dainippon Pharmaceutical Co., Ltd., and Sumitomo Pharmaceuticals Co., Ltd. Today, Sumitomo Dainippon Pharma has more than 6,000 employees worldwide. Additional information about Sumitomo Dainippon Pharma is available through its corporate website at https://www.ds-pharma.com/.

Forward-Looking Statements
This press release contains "forward-looking statements" concerning the development and commercialization of Altavant's products, the company's business development efforts and its expectations regarding its prospects. Forward-looking statements are subject to risks, assumptions and uncertainties that could cause actual future events or results to differ materially from such statements. These statements are made as of the date of this press release. Actual results may vary. Altavant undertakes no obligation to update any forward-looking statements for any reason.

SOURCE Altavant Sciences

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