Liquidia Studies Show PRINT Engineered Particles Hold Promise in the Delivery of Respiratory Therapeutics

RESEARCH TRIANGLE PARK, N.C., May 15, 2012 -- Liquidia Technologies today announced the results of two newly-released studies that illustrate the unique benefits of the company's proprietary PRINT(R) (Particle Replication In Non-Wetting Templates) platform in the development of advanced respiratory therapeutics. Despite the high prevalence of lung disease, optimizing critical parameters of respiratory therapeutics to improve their pulmonary distribution and effectiveness has remained a challenge for the biopharmaceutical industry. These studies demonstrate how the PRINT platform can be used for respiratory drugs by precisely engineering particles with controlled shape, size, and chemistry, all characteristics that could lead to better lung delivery and therapeutic performance. Aspects of these findings were published in the Journal of Drug Delivery and presented at the Respiratory Drug Delivery Conference being held May 13-17, 2012 in Phoenix, Arizona.

The study published in the 2012 issue of the Journal of Drug Delivery demonstrates the features and benefits that make the PRINT particle engineering platform unique for the development of respiratory therapies, including its ability to mold and formulate small molecule, nucleic acid, and protein-based drugs while maintaining the chemical structure and activity of the compound. The study shows that the unique micro-molding technique employed using the PRINT technology allows Liquidia to finely control drug particle size within the respirable range (< 5 um) and with unparalleled accuracy, allowing for enhanced respiratory drug delivery to specific regions of the lung like the alveolar space or central airways.

"It is understood that particle size and shape can play a significant role in the way an aerosolized medicine is distributed throughout the lung, but until now, complete control of these particle characteristics has not been possible," said Benjamin Maynor, Executive Director of Research at Liquidia Technologies and the lead investigator of this study, "The PRINT platform allows Liquidia and its partner companies to rapidly design and manufacture a diverse range of precisely engineered therapeutic particles that can be used for the unprecedented exploration of new product opportunities in the treatment of respiratory disease."

Another study, presented today at the 2012 Respiratory Drug Delivery Conference, investigated the performance of engineered PRINT particles for the delivery of a poorly soluble drug as a dry powder formulation. Using itraconazole as the reference drug, the study showed that use of significantly smaller PRINT particles (1.42 um(3)volume median diameter) resulted in an inhalation formulation with a two-fold increase in the fraction of drug that reaches the lungs and a two-fold reduction in the time required to achieve 50% dissolution when compared with jet-milled particles (2.52 um(3)volume median diameter).

"By leveraging precise fabrication techniques of the semiconductor industry, Liquidia has the unique ability to address persisting unmet needs in respiratory medicine and other therapeutic areas," said Kyle Chenet, Vice President of Development at Liquidia, "The growing body of data supporting the benefits of PRINT technology highlights the exciting potential for Liquidia and its partners to develop novel pulmonary products, including biologics and combined therapeutics, with significantly increased aerosol performance, controlled release, reduced excipient load, and/or targeted delivery ."

ABOUT THE STUDIES

Microfabricated Engineered Particle Systems for Respiratory Drug Delivery and Other Pharmaceutical Applications -- published in the 2012 issue of Journal of Drug Delivery

Authors of this study concluded that the PRINT process is well suited for the production of high-performance aerosol particles for respiratory drug delivery. Precise control over size and shape allows for defined aerodynamic properties, which, in turn, leads to enhanced aerosol performance. This was specifically demonstrated by comparing the aerosol characteristics of PRINT drug particles to those of the marketed product, Relenza, which has the active ingredient zanamivir. The PRINT-zanamivir inhalation powder showed a reduction in mass median aerodynamic diameter (from 3.4 um to 2.3 um) and a greater than three-fold increase in fine particle fraction or the fraction of drug that is delivered to the lung. Moreover, the control over particle aerodynamic properties that PRINT particles enable leads to differential lung deposition in vivo, a concept highlighted using a canine imaging model in which smaller particles were shown to deposit more deeply in the lung. In addition to the benefits imparted by control over particle size and shape, PRINT particles are presented as a versatile strategy for formulating particle systems of small molecules, biologics, oligonucleotides, and drug/excipient mixtures. Overall, PRINT particles are a viable particle design strategy that may address challenges existing for respiratory drug delivery and other dosage forms, thereby constituting a promising opportunity for the development of next-generation therapeutics. This complete study article can be found on the Journal of Drug Delivery website at http://bit.ly/KQIvHq .

Microfabricated Itraconazole for Enhanced Respiratory Delivery and Dissolution -- presented this week at the Respiratory Drug Delivery Conference

In the study, investigators used the PRINT platform to develop an excipient-free itraconazole drug-particle formulation that demonstrated significantly improved aerosol properties and a faster dissolution rate when compared with respirable jet-milled itraconazole. Specifically, the PRINT particle formulation demonstrated a 25 percent increase in the amount of dry powder that exits the inhalation device (emitted dose) and a two-fold increase in the amount of dry powder predicted to deposit in the lungs (fine particle fraction) when compared with the jet-milled formulation. The study also showed an improved dissolution rate when using the PRINT formulated product, as measured by the time required to achieve 50% drug dissolution. This target was reached for the PRINT formulated product within 5 minutes, while the jet-milled formulation and bulk itraconazole required 10 and 45 minutes, respectively.

ABOUT LIQUIDIA

Liquidia Technologies, founded in 2004, is a privately held biotechnology company located in Research Triangle Park, North Carolina. By leveraging precise fabrication techniques of the semiconductor industry, Liquidia has become the only company in the world with the ability to rapidly design and manufacture precisely engineered particles of virtually any size, shape, or composition using a unique particle engineering and manufacturing platform know as PRINT(R). This unique ability to precisely engineer particles enables scientists to explore new product frontiers that, until now, have otherwise been out of reach for the life sciences industry. In addition to the development of its own products, Liquidia licenses its PRINT particle technology and its cGMP manufacturing capabilities to support proprietary programs advanced by collaborators. For more information, please go to www.liquidia.com .

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