Liquidia files for IPO to challenge United Therapeutics in PAH | Bio Tech

Liquidia Technologies has filed for a $57.5 million IPO to take its twist on United Therapeutics’ Tyvaso through phase 3. The experimental pulmonary arterial hypertension (PAH) candidate is a dry powder formulation of the active ingredient in Tyvaso.

North Carolina-based Liquidia applied its engineering platform to the ingredient, treprostinil, to create trefoil-shaped, uniformly-sized particles. Liquidia thinks the tweaks may reduce the particle deposition in the upper airways that occurs when Tyvaso is delivered via nebulizers, resulting in more of the active ingredient penetrating deep into the lungs.

The IPO will set Liquidia up to learn whether the idea works in practice. Liquidia started a 100-person phase 3 trial of the candidate, LIQ861, around the start of the year. At the last count, Liquidia had enrolled 22 patients and was on track to deliver safety data in the first half of next year.

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Liquidia expects the FDA to accept a filing for approval under the 505(b)(2) regulatory pathway based on the single, 100-patient phase 3, giving it a truncated path to market. If approved, LIQ861 would challenge Tyvaso in PAH. Last time an upstart challenged United in PAH, it bought the potential rival, paying $216 million to acquire SteadyMed and its pump-delivered formulation of treprostinil.

With insider commitments already secured, Liquidia thinks it can raise enough cash in the IPO to complete the phase 3 trial and advance its follow-up program. The second drug, LIQ865, is expected to work its way through phase 2-enabling toxicology studies this year.

In developing LIQ865, Liquidia has used the same engineering platform behind LIQ861 to achieve different goals. LIQ865 is an injectable, sustained-release formulation of the non-opioid anesthetic bupivacaine.

By engineering the particles to modify the release profile of bupivacaine, Liquidia thinks it can provide patients with three to five days of local pain relief after they undergo surgery. That is longer than Pacira Pharmaceuticals’ liposomal formulation of bupivacaine achieves. But, with generic copies of that drug, Exparel, on the horizon, Liquidia will need to clearly differentiate LIQ865 to get payers to back its product.

Liquidia also has a collaboration with GlaxoSmithKline, although the status of a key candidate in the alliance is uncertain. GSK is testing the COPD prospect in a phase 1 study but Liquidia thinks its partner will pull the plug on the program once the trial is finished.

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