Pharmaceutical company Lung Therapeutics, Inc. has received the orphan medicinal product designation from the European Commission (EC) for its lead drug candidate LTI-01 for the treatment of empyema, a complication related to pneumonia. The status was granted due to positive reviews from the Committee for Orphan Medicinal Products (COMP) within the European Medicines Agency (EMA), as announced by the company in a recent press release.
The orphan drug designation granted by the European authorities provides LTI-01 up to ten years of marketing exclusivity in the European Union after the drug’s marketing approval, as well as a series of other benefits, such as funds to support further research, protocol assistance, and fee reductions. “Having consulted on other EU orphan drug submissions in the past, I know how challenging the process can be,” explained the co-founder of Lung Therapeutics and consulting head of product development, Andrew P. Mazar, PhD.
“Accomplishing this important milestone is a significant achievement. In addition to 10 years of market exclusivity, EC orphan drug designation provides regulatory and financial incentives to develop and market therapies that treat a life-threatening or chronically debilitating condition affecting no more than five in 10,000 persons in the European Union, and where no satisfactory treatment has been available. We now have the potential to help patients around the world who previously had few if any viable options,” he added.
Austin, Texas-based Lung Therapeutics is focused on the development of therapies for the treatment of niche and orphan conditions, seeking to address unmet therapeutic needs in lung medicine. LTI-01 is one of its main products, which is an injectable, fibronolytic medication designed to improve the removal of scar tissue surrounding the lungs in order to allow the draining of fluid and reduce the risk of bleeding and other complications.
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In addition, the company believes that LTI-01 is able to compete with other therapeutic options by replacing surgeries that not only involve longer recovery time, but also higher treatment costs and ineffective off-label treatments. The drug is intended to improve clinical outcomes and provide a safer and more cost-effective therapy for both lung disease patients and healthcare professionals.
“We are pleased that the European Commission has recognized the potential of LTI-01 to improve patient outcomes in the treatment of empyema in Europe,” stated the CEO of Lung Therapeutics, Brian Windsor, PhD. “This designation, along with the orphan drug status we have already received in the U.S. from the FDA, underscores the unmet medical need LTI-01 addresses for patients suffering from empyema.”
Last December, the company received the orphan drug designation for LTI-01 from the U.S. Food and Drug Administration, which is granted to promising treatments geared towards treating diseases prevalent in less than 200,000 Americans. The status also allows the company to take advantage of seven years of market exclusivity following the drug’s marketing approval in the United States. The company is now panning on moving the LTI-01 program into clinical trials during this year.
In addition to LTI-01, Lung Therapeutics is also working on other pipeline programs, including LTI-02 for the treatment of Acute Lung Injury (ALI) and LTI-03 for the treatment of Idiopathic Pulmonary Fibrosis (IPF). In order to fund its research, the company has recently closed $1,550,000 on Series A Preferred Stock financing, which is comprised of $550,000 in converted debt, as well as a remaining funding of $1,200,000 associated with the fulfillment of milestones, due to partnership between the Dallas/Fort Worth-based enterprises Steelhead Capital Management and Bios Research.