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Press Release

Altavant Sciences Finds Nebulized ALTA-2530 Retains Potency and Reaches Target Lung Tissues, Supporting Continued Investigation for Treatment of BOS

Cary, N.C. and Basel, Switzerland – April 26, 2021 – Altavant Sciences, a clinical-stage biopharmaceutical company focused on patient-centric drug development in rare respiratory diseases, presented results of in vitro and in vivo studies for nebulized ALTA-2530, a novel inhaled formulation of recombinant human IL-1 receptor antagonist (rhIL-1Ra) currently in nonclinical development for the treatment of bronchiolitis obliterans syndrome (BOS). These studies demonstrated that ALTA-2530 achieved and maintained pharmacologically relevant exposure levels in lung epithelial lining fluid and distributed to epithelial cells of the lung’s distal airways. Additional studies demonstrated the rhIL-1Ra protein was stable and retained full potency during nebulization. Together, these findings support the further investigation of ALTA-2530 for the treatment of BOS, a life-threatening form of chronic lung allograft dysfunction (CLAD) that leads to fibrosis of the small airways (bronchioles) and eventual partial or total obstruction of the distal airways.

During the ISHLT virtual poster session, Altavant presented results from studies in animal models that showed that nebulized ALTA-2530 reached the lung epithelial lining fluid at concentrations ~2,500-fold higher than those measured in serum. Further, concentrations in the epithelial lining fluid 24 hours after administration were greater than 29-fold the half maximal inhibitory concentration (IC50), a measure of a drug’s potency. In non-human primates, immunohistochemistry demonstrated ALTA-2530 distributed to the epithelial cells of the distal bronchioles. ALTA-2530 was well tolerated in all acute and repeat-administration toxicity studies performed.

“BOS is a life-threatening complication that sadly develops all too frequently following lung transplantation. Current therapies, including cyclosporine A or tacrolimus that modulate the adaptive immune system following transplant, are not approved for the treatment of BOS. BOS treatment likely requires new mechanisms to address the underlying dysregulation of the innate immune system that is potentially mediated by interleukin-1 (IL-1) signaling” said Steve Wring, Ph.D., Altavant’s VP of R&D and author of the ISHLT poster. “Our findings show that the nebulized ALTA-2530 formulation generates particles of an optimal size for delivery to the small airways of the lung, and that pharmacological levels persist in lung for at least 24 hours. These findings reinforce our confidence in ALTA-2530’s potential to quell the inflammatory cascade in the deep tissues of the lung, where BOS manifests.”

The Altavant poster, Inhalation of IL-1 Receptor Antagonist (ALTA-2530) Achieves Stable and Prolonged Pulmonary Exposure in Nonclinical Studies Supportive of Development for Bronchiolitis Obliterans Syndrome, is available on the Altavant Publications webpage.

In addition, Altavant provided an update on its clinical program for its lead candidate, rodatristat ethyl, during a non-CME symposium titled: Serotonin Pathobiology in Pulmonary Arterial Hypertension (PAH) and Phase 2b Investigation of the Novel Therapy Rodatristat Ethyl (RE) in WHO Group 1 PAH. Altavant is currently screening patients for enrollment in ELEVATE 2 (NCT identifier: NCT04712669), a Phase 2b study for the treatment of PAH, in the US, Canada, and EU. More information on ELEVATE 2 may be found on the study’s website at elevatepahstudy.com and on the Altavant website.

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 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 a recombinant human interleukin-1 receptor antagonist under development for chemical lung injury and 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.

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