Windtree Therapeutics Announces FDA Fast Track Designation for Istaroxime in Acute Heart Failure and Files Prospectus

On August 22, 2019, VCBeat (WeChat ID: vcbeat) learned from foreign media reports that Windtree Therapeutics (“Windtree”), a biopharmaceutical and medical device company, announced that its acute heart failure treatment drug, Istaroxime, had been granted Fast Track designation by the U.S. Food and Drug Administration (FDA).

Istaroxime is a first-in-class intravenous drug primarily used for the clinical treatment of patients with acute heart failure. Administered via intravenous infusion, this agent exerts dual effects that help restore both systolic and diastolic function in the compromised heart.

Windtree recently announced the results of the Phase IIb clinical study of Istaroxime, confirming that the drug demonstrates favorable efficacy in improving cardiac function in patients with acute heart failure while helping them maintain normal blood pressure. Additionally, Windtree conducted a preliminary review of the safety and treatment-related side effects of Istaroxime.

The FDA considers that a drug in clinical development may be granted Fast Track designation if sufficient data from clinical trials demonstrate its significant efficacy against serious diseases. The FDA will provide a series of clinical development support measures to drugs receiving this designation and prioritize the review of their marketing applications. This initiative aims to facilitate drug development and accelerate the market availability of new therapies for life-threatening serious diseases.

Windtree, founded in 1992 and headquartered in Pennsylvania, USA, is a clinical-stage biopharmaceutical and medical device company. The company focuses on developing novel therapies and pharmaceutical products to provide safe and effective treatment options for patients with respiratory diseases, pulmonary conditions, and acute cardiovascular diseases. Currently, Windtree is conducting three clinical drug trials and multiple preclinical drug research projects. The company went public in 2017, trading under the ticker symbol WINT.

Windtree is dedicated to developing novel surfactant therapies to improve clinical outcomes for patients with respiratory diseases. The company has synthesized KL4 peptide-containing surfactant based on its proprietary technology platform for the treatment of respiratory distress syndrome (RDS) in premature infants. Meanwhile, Windtree is also developing novel drug delivery technologies to facilitate the non-invasive administration of KL4 surfactant.

Scientific research has found that the human SERCA2a gene can regulate the sarcoplasmic reticulum's ability to take up calcium ions. Based on this mechanism, Windtree is conducting preclinical studies on other heart failure treatments. In addition, the company has developed a series of candidate drugs for patients with hereditary hypertension.

Windtree executives stated, “We will actively advance the clinical development of Istaroxime, while continuing to collaborate with biotechnology companies in the field of cardiology to develop new therapies for acute heart failure.”

Craig Fraser, President and Chief Executive Officer of Windtree Therapeutics, said, “We are pleased that istaroxime has received FDA Fast Track designation. Results from the Phase II clinical trial demonstrated that the drug is highly effective in patients with acute heart failure, addressing an important unmet medical need.”

(Compiled by Xu Xiaoxue)