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Thursday, 22 October 2020

PARI's optimized Investigational eFlow® Technology nebulizer delivering well tolerated aerosols of AR-501 in Aridis´ Phase 1/2a clinical trial


PARI Pharma’s proprietary aerosol delivery platform, eFlow Technology, continues its long track record of success with Aridis Pharmaceuticals.


STARNBERG, Germany, October 22nd, 2020 – PARI Pharma’s proprietary aerosol delivery platform, eFlow Technology, continues its long track record of success with Aridis Pharmaceuticals (San Jose, CA). In June, Aridis announced positive results from the Phase 1 part of its Phase 1/2a clinical trial of AR-501 conducted using an optimized Investigational eFlow Technology nebulizer. AR-501 is an inhaled formulation of gallium citrate which is developed for the treatment of chronic lung infections in patients with cystic fibrosis (CF). The Phase 1/2a clinical trial is a randomized, double blinded, placebo-controlled study evaluating the safety and pharmacokinetics of AR-501 in healthy volunteers and Pseudomonas aeruginosa infected CF patients. AR-501 is developed as a once-per-week dosing regimen that is self-administered using an eFlow Technology nebulizer system. eFlow Technology devices are already featured in several approved FDA products in the US and multiple clinical trials for newly developed therapies.

Last month, Aridis also reached an agreement with the US Food and Drug Administration (FDA) to simplify the company's AR-501 Phase 2 trial design by streamlining AR-501's forthcoming Phase 2a clinical trial in CF patients. Furthermore, the FDA also concurred with the company's proposal to expand the originally planned Phase 2a protocol design into a Phase 2a/2b study.

“We are delighted about Aridis´ achievements and happy that we were able to make an important contribution by providing our partner with a nebulizer from our eFlow Technology platform specifically optimized for AR-501. With this non-antibiotic, broad acting antimicrobial in CF we once again have the opportunity to extend the variety of drug formulations administered with eFlow Technology nebulizers and offer additional treatment options to patients suffering from CF”, said Dr. Stefan Seemann, Vice President eFlow Development and Operations at PARI Pharma.

About PARI Pharma GmbH and eFlow Technology
PARI is a world leader in the development of aerosol delivery devices. PARI Pharma develops, commercializes, and manufactures optimized eFlow Technology nebulizers in cooperation with partners from the pharmaceutical industry and contributes to advanced drug-device combination products that bring relief for patients with serious lung diseases.

eFlow Technology is an aerosol delivery platform that enables efficient nebulization of liquid medications via a vibrating, perforated membrane. eFlow Technology devices are designed to significantly improve upper and lower respiratory tract deposition and reduce the burden of treatment for patients with severe respiratory conditions.

PARI Pharma is located near Munich, Germany, with a major presence in the United States. For more information, please visit www.pari.com/eFlow-partnering.

About AR-501
AR-501 is an inhaled formulation of gallium citrate delivered via an optimized eFlow Technology nebulizer and it is being developed to treat chronic lung infections in cystic fibrosis patients. It is a non-antibiotic, broad acting antimicrobial with a mechanism of action involving interference with iron and disruption of microbial iron-dependent metabolic pathways distinct from current antibiotics. AR-501 acts as an iron analog and is believed to disrupt multiple iron dependent pathways in microbes, leading to growth inhibition. AR-501 has antimicrobial activities against several gram-negative and gram-positive bacteria, including antibiotic resistant strains.

eFlow® is a registered trademark of PARI Pharma GmbH.
 

Contact:
Michael Hahn
Director eFlow Partnering & Strategy
PARI Pharma GmbH
+49 (0) 89 74 28 46 -831
michael.hahnpari.com

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