Pulmonary Hypertension Therapy Developer MannKind Retains Biopharma Financing Specialist

MannKind Corporation, which is developing the pulmonary arterial hypertension (PAH) therapy Treprostinil Technosphere, has retained the biopharmaceutical financing specialist Locust Walk to help it raise capital for Treprostinil and other projects.

Locust Walk lines up investors and strategic partners for companies like MannKind, which also wants to use its Technosphere technology to develop treatments for respiratory diseases, anaphylactic shock, pain and nausea.

“MannKind has focused its financial resources on the commercialization of [the inhaled insulin therapy] Afrezza, and is seeking alternate means to fund our other development programs for the Technosphere platform,” Raymond Urbanski, the company’s chief medical officer, said in a press release. “I am excited to collaborate with Locust Walk, which has extensive global experience in pharmaceutical partnering, to help bring our product candidates to market.”

Those projects include Epinephrine Technosphere for anaphylaxis shock and Palonosetron Technosphere for chemotherapy-geneated nausea and vomiting.

The active ingredient treprostinil that is in Treprostinil Technosphere can also be found in medicines like Remodulin, which is administered intravenously, and Tyvaso, which is administered as an inhalant. United Therapeutics markets both products. The U.S. Food and Drug Administration approved Remodulin in May 2002 and Tyvaso in July 2009.

Treprostinil is a synthetic form of prostacyclin, which belongs to a class of signaling molecules called eicosanoids. These molecules are potent vasodilators, or substances that widen blood vessels, allowing oxygen-carrying blood to get to the lungs more easily. They are widely used in the treatment of PAH, preventing the disease from worsening and improving patients’ exercise capacity.

Hallmarks of the Technosphere platform are simple and needle-free administration of a treatment, rapid action, no impact on the liver, and improved bioavailability, or the proportion of a treatment that enters circulation. That proportion is an indication of whether a therapy will work.

Treprostinil Technosphere combines treprostinil with a novel drug delivery system that MannKind developed. The company has tested three formulations of Treprostinil Technosphere, two of which have advanced to the clinical-trial evaluation stage.

MannKind plans to submit an Investigational New Drug application on Trepostinil Technosphere to the FDA at the end of the second quarter of 2017. Phase 1 clinical trials of Trepostinil Technosphere should be conducted between the second and third quarters of this year, while Phase 2 trials are scheduled to begin in the final quarter of 2018.