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Post by mnholdem on Jan 3, 2018 12:38:58 GMT -5
Liquidia Initiates Phase III Clinical Trial of LIQ861 in Patients with Pulmonary Arterial Hypertension Jan. 3, 2018 13:30 UTC
RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)-- Liquidia Technologies Inc., a late-stage clinical biopharmaceutical company focused on improving the performance of medicine by precisely engineering drug particles, today announced the initiation of a Phase 3 clinical trial evaluating LIQ861 for the treatment of pulmonary arterial hypertension (PAH). LIQ861, developed using Liquidia’s proprietary PRINT® technology, is a powder formulation of treprostinil designed for deep-lung delivery using a disposable, dry powder inhaler (DPI).
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Liquidia expects to enroll at least 100 patients with PAH across multiple U.S. sites in the open-label Phase 3 clinical trial, with the first patient enrolling within the next few weeks. Primary endpoints of the trial are long-term safety and tolerability of LIQ861. Topline data are expected in 2019. In March 2017, Liquidia completed a Phase 1 clinical trial of LIQ861 in healthy volunteers in which the drug was well tolerated at all doses, with a proportional response in pharmacokinetics. Liquidia anticipates reporting additional data from this Phase 1 trial at scientific conferences in 2018. Based on feedback from the FDA, Liquidia believes that the Phase 3 clinical trial will support a potential U.S. regulatory approval of LIQ861.
“While treatment options exist for PAH, there is still a strong need for innovation to make it easier for patients to self-administer some of the more complex therapies,” said Nicholas Hill, MD, Chief Pulmonary, Critical Care & Sleep Division and Professor of Medicine at Tufts University School of Medicine. “Leveraging Liquidia’s PRINT® technology to enable deep-lung delivery of inhaled treprostinil, LIQ861 offers the convenience of a dry powder inhaler, which greatly simplifies the delivery of inhaled treprostinil and I believe may likely improve the lives of such patients.”
Source: www.biospace.com/article/releases/liquidia-initiates-phase-3-clinical-trial-of-liq861-in-patients-with-pulmonary-arterial-hypertension/
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Post by centralcoastinvestor on Jan 3, 2018 12:45:43 GMT -5
I wonder what the difference is between their product and MannKind’s Trepostinil Technosphere. It looks like both use a powder formulation. Interesting find.
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Post by kbrion77 on Jan 3, 2018 13:19:28 GMT -5
Would benefit Mannkind tremendously if steam started to pick up on inhaled therapeutics. Hope this company makes big progress.
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Post by boca1girl on Jan 3, 2018 13:24:48 GMT -5
Would benefit Mannkind tremendously if steam started to pick up on inhaled therapeutics. Hope this company makes big progress. I hope Mannkind is aware of the product and gets moving quickly on it’s version. |
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Post by MnkdWASmyRtrmntPlan on Jan 3, 2018 13:41:32 GMT -5
Would benefit Mannkind tremendously if steam started to pick up on inhaled therapeutics. Hope this company makes big progress. I hope Mannkind is aware of the product and gets moving quickly on it’s version. That article says that "In March 2017, Liquidia completed a Phase 1 clinical trial of LIQ861", so MNKD should be aware of it. Maybe that's why they appear to have advanced it in front of epinephrine. |
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Post by brentie on Jan 3, 2018 14:15:36 GMT -5
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Post by Deleted on Jan 3, 2018 14:20:35 GMT -5
boca1girl "I hope Mannkind is aware of the product and gets moving quickly on it’s version." MannKind doesn't have the money to initiate any new trials.
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Post by dreamboatcruise on Jan 3, 2018 15:25:54 GMT -5
At one point I hoped that MNKD's patent portfolio would create barriers to other inhalable powder technologies, but it appears that it may only prevent companies from using FKDP for powders.
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Post by centralcoastinvestor on Jan 3, 2018 15:47:18 GMT -5
From briefly reading this, it appears that Liquidia Techologies has made the dry powder directly from Trepostinil. In other words, Trepostinil is not loaded onto anything. The patient would be taking a dry powder form of Trepostinil. Whereas, with MannKind, the Trepostinil would be loaded onto to Technosphere partical. The Technosphere partical is very stable and has been shown to disperse well in the lung. So I wonder how well the Liquidia partical disperses in the lung. It would be my hunch that the Liquidia version will take a lot more Trepostinil to do the job than a Technosphere version. But that is just a hunch. |
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Post by dreamboatcruise on Jan 3, 2018 22:34:58 GMT -5
From briefly reading this, it appears that Liquidia Techologies has made the dry powder directly from Trepostinil. In other words, Trepostinil is not loaded onto anything. The patient would be taking a dry powder form of Trepostinil. Whereas, with MannKind, the Trepostinil would be loaded onto to Technosphere partical. The Technosphere partical is very stable and has been shown to disperse well in the lung. So I wonder how well the Liquidia partical disperses in the lung. It would be my hunch that the Liquidia version will take a lot more Trepostinil to do the job than a Technosphere version. But that is just a hunch. So your hunch is that they don't have good control over particle size and much of the powder would not reach the alveoli? Though that is really only important if the API is expensive relative to the selling price. |
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Post by babaoriley on Jan 3, 2018 23:42:01 GMT -5
At one point I hoped that MNKD's patent portfolio would create barriers to other inhalable powder technologies, but it appears that it may only prevent companies from using FKDP for powders. My wisdom, although very limited, on relying on patents - don't ever! |
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Post by kc on Jan 3, 2018 23:44:36 GMT -5
I wonder what the difference is between their product and MannKind’s Trepostinil Technosphere. It looks like both use a powder formulation. Interesting find. Looks like they are working with GSK  goo.gl/images/Tm3HjY |
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Post by mytakeonit on Jan 4, 2018 0:45:33 GMT -5
Well obviously it won't work ... the numbers and alpha are all backwards. Ha! Looks like a normal inhaler ...
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Post by dreamboatcruise on Jan 4, 2018 1:24:04 GMT -5
At one point I hoped that MNKD's patent portfolio would create barriers to other inhalable powder technologies, but it appears that it may only prevent companies from using FKDP for powders. My wisdom, although very limited, on relying on patents - don't ever! With my two companies I certainly didn't waste a lot of time with patents. They aren't very useful for small companies. It takes a war chest of money to give them teeth. MNKD has certainly put a lot of effort and money into getting a pile of them. But their financial straights would limit the perceived threat from them. |
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Post by mnholdem on Jan 7, 2018 9:11:52 GMT -5
It's no surprise that Glaxo-Smith-Kline has a vested interest in this technology. They recently finished building a spanking new manufacturing facility in the U.K. for production of inhalable drugs.  |
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