DGAP-News: Breath Therapeutics BV / Key word(s): Study
Breath Therapeutics Announces Initiation of Global Phase 3 Trials for the Treatment of Bronchiolitis Obliterans Syndrome
- Phase 3 BOSTON clinical studies will evaluate Liposomal Cyclosporine A for Inhalation
- BOS is a devastating lung disease with high mortality affecting over 30,000 people worldwide following lung or allogeneic hematopoietic stem cell transplantation
Munich, Germany and Menlo Park, Calif. - March 26, 2019 - Breath Therapeutics, a private company developing advanced inhaled therapeutics in severe pulmonary orphan diseases, announced today the initiation of the Phase 3 BOSTON clinical studies of L-CsA-i for the treatment of Bronchiolitis Obliterans Syndrome (BOS). Breath Therapeutics' lead drug candidate, L-CsA-i, is a proprietary liposomal formulation of cyclosporine A for inhalation administered via a drug-specific investigational eFlow(R) nebulizer (PARI Pharma). L-CsA-i has received orphan drug designation for the treatment of BOS from the Food and Drug Administration and European Medicines Agency.
The harmonized global randomized, controlled studies will evaluate the efficacy and safety of L-CsA-i in individuals with BOS following a single lung (BOSTON-1) or double lung (BOSTON-2) transplantation. The primary endpoint is mean change in FEV1 (mL) from baseline to week 48 and the key secondary endpoints are mean change in FEV1/FVC and time to progression of BOS. Each study will enroll 110 participants at leading lung transplant specialty centers in eight countries. Upon completion of the 48-week studies, all participants will be eligible to continue in the planned BOSTON-3, an open-label extension trial. Additional information is available at ClinicalTrials.gov. (BOSTON-1 NCT03657342) (BOSTON-2 NCT03656926). To view experts discuss their clinical experience with BOS and the BOSTON-1 and BOSTON-2 studies, please visit here.
Jens Stegemann, Chief Executive Officer of Breath Therapeutics, said, "The initiation of the BOSTON pivotal trials represents a major milestone for Breath Therapeutics and is indicative of the outstanding progress we have achieved in the past 24 months. We have accomplished full commercial scale production capability of both the drug and the drug-specific inhalation device, and have also assembled an exceptional leadership team to execute on our clinical development programs and global commercialization strategy. Together with the enthusiasm and commitment of our renowned investigators and their teams from more than 35 of the leading lung transplant centers world-wide, we are well positioned to succeed in our goal of bringing an effective and safe treatment to people with BOS."
Joseph M. Pilewski, MD, Associate Chief for Clinical Affairs and lung transplant physician in the Division of Pulmonary, Allergy & Critical Care Medicine at the University of Pittsburgh Medical Center, stated, "Although lung transplant survival has improved with the advancement of surgical techniques and perioperative management, and more individuals are undergoing lung transplantation, survival has not improved to reach the rate of other organ transplantations. One key factor impacting survival in lung recipients is rejection, particularly bronchiolitis obliterans syndrome (BOS), the most common form of chronic lung allograft dysfunction. The BOSTON trials are timely and important to lung recipients and the broader lung transplant community because inhaled cyclosporine may provide the first safe and effective treatment for BOS."
Antonio Román, MD, Medical Coordinator of the Lung Transplantation and Director of PAH Unit at Hospital Vall d'Hebrón, Barcelona, said, "We are pleased the BOSTON trials have started and are appreciative for the opportunity to contribute to this important global program. Bronchiolitis obliterans syndrome is a devastating disease for patients and their loved ones and there is an urgent need for a suitable therapy for this underserved community."
Bronchiolitis Obliterans Syndrome (BOS)
Liposomal Cyclosporine A for Inhalation (L-CsA-i)
BOSTON Development Program
By its very nature, forward-looking information requires Breath Therapeutics to make assumptions and is subject to inherent risks and uncertainties which give rise to the possibility that the predictions, forecasts, expectations or conclusions will not prove to be accurate, that Breath Therapeutics' assumptions may not be correct and that Breath Therapeutics' objectives, strategic goals and priorities will not be achieved. Although Breath Therapeutics believes that the predictions, forecasts, expectations or conclusions reflected in the forward-looking information are reasonable, it can give no assurance that such matters will prove to have been correct. Such forward-looking information is not fact but only reflects management's estimates and expectations. These forward-looking statements are subject to uncertainties and other factors that could cause actual results to differ materially from such statements.
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26.03.2019 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG.