Cary, N.C. and Basel, Switzerland – August 5, 2020 – Altavant Sciences, a clinical-stage biopharmaceutical company focused on patient-centric drug development in rare respiratory diseases, today presented results from in vivo nonclinical studies of rodatristat ethyl, a TPH inhibitor in clinical development for PAH. The studies demonstrated enhanced distribution of rodatristat ethyl in lung tissue consistent with levels associated with disease modification in preclinical models and also demonstrated minimal brain exposure supporting a lack of impact on brain serotonin levels. These findings were presented in a thematic poster session at the annual meeting of the American Thoracic Society on August 5, 2020.
In an in vivo distribution study presented at ATS, rats were administered a single oral dose of radiolabeled rodatristat ethyl after which they were assessed by quantitative whole-body autoradiography. This type of study is frequently used to assess tissue distribution of compounds, including blood brain barrier penetration. Rodatristat exposure was measured at low levels in brain tissue approximating the detection limit (∼0.1μg/g) and ~1/9th the exposure in blood. Exposure in lung tissue was markedly higher at ~5X exposure in blood. In repeat dose studies performed, brain levels of serotonin in monocrotaline induced PAH rats were not reduced compared to untreated control rats. These findings are supportive of minimal blood-brain barrier penetration. In contrast, levels of rodatristat ethyl found in lung tissue were higher than that observed in blood suggesting rodatristat accumulates in the lung, and is correlated with a reduction in serotonin in healthy and disease model rats and efficacy observed in nonclinical PAH disease models.
“These in vivo results represent important evidence that rodatristat ethyl can act on serotonin production in the periphery of the body to ameliorate the pathology of PAH while preserving the availability and activity of serotonin in the brain,” said William T. Symonds, Pharm.D., Chief Executive Officer of Altavant. “Results of these studies, together with the tolerability profile we’ve observed in clinical studies to date, give us confidence in rodatristat ethyl’s potential to be a meaningful treatment option for 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. Altavant is currently advancing two pipeline candidates: rodatristat ethyl and ALTA-2530. Rodatristat ethyl is in Phase 2 development for patients with pulmonary arterial hypertension. A tryptophan hydroxylase (TPH) inhibitor, rodatristat ethyl 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 interleukin-1 receptor antagonist under development for bronchiolitis obliterans syndrome (BOS), a life-threatening complication of 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., which is a wholly owned subsidiary of Sumitomo Dainippon Pharma Co., 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 Urovant, and wholly owns Enzyvant, Spirovant and Altavant. Sumitovant’s pipeline is comprised of early- through late-stage investigational medicines across a range of disease areas targeting high unmet need. 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/.
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.