U.S. Patent Approval Expected for LIQ861 Treprostinil Dry Powder

Liquidia Technologies has received a notice of allowance from the U.S. Patent and Trademark Office, indicating that a patent application for LIQ861, the company’s investigational dry powder formulation of treprostinil, should be approved.

The patent is expected to cover methods of treating patients with pulmonary arterial hypertension (PAH) through the inhalation of dry powder treprostinil, according to Liquidia. Liquidia expects the patent to be issued by the end of 2020, and to expire no earlier than 2037.

“The allowance of this patent will substantially strengthen and extend our intellectual property position with respect to dry powder inhaled treprostinil and represents an important milestone for LIQ861 on its path to potential commercialization,” Neal Fowler, CEO of Liquidia, said in a press release.

If approved, Liquidia intends to list the patent for LIQ861 in the Approved Drug Products with Therapeutic Equivalence Evaluations, known as the Orange Book, which identifies approved products based on their safety and efficacy data.

Treprostinil has already been approved in the U.S. under the name Remodulin as an infusion or under-the-skin injection formulation. The developers of Remodulin, United Therapeutics, also market treprostinil as Orenitram, an extended-release oral tablet formulation, and Tyvaso, an inhaled formulation.

A dry powder designed to be directly inhaled through a user-friendly, hand-held inhaler, LIQ861 is considered to be a more convenient formulation than Tyvaso, which requires 36 breaths per day.

“LIQ861 has the potential to address a significant unmet need for PAH patients seeking effective and convenient dosing of inhaled treprostinil,” Fowler said. “We are thrilled to have received this patent allowance for methods of treating patients with inhaled dry powder treprostinil.”

The development of LIQ861 was facilitated by Liquidia’s PRINT technology, a particle engineering platform that allows for the precise production of highly uniform drug particles by controlling their size, shape, and chemical composition. This technology was used to enhance and optimize LIQ861’s deep-lung delivery.

The treatment is currently under review by the U.S. Food and Drug Administration. The U.S. agency has set a Prescription Drug User Fee Act (PDUFA) action date for Nov. 24. By then, it will decide whether to approve LIQ861 for this indication.

A Phase 3 clinical trial (NCT03399604) called INSPIRE is currently ongoing to investigate the safety and efficacy of LIQ861, as is an extension study (NCT03992755).

A total of 121 people with PAH were enrolled in INSPIRE, which primarily monitored patients for signs of adverse reactions to LIQ861 after transitioning from an oral or inhaled formulation of treprostinil.

The results so far indicate that LIQ861 treatment is safe and well-tolerated, and that it can improve exercise capacity and quality of life in PAH patients.