Laval, Quebec, December 14, 2021 – Altasciences’ pharmaceutical contract manufacturing site in Philadelphia, PA, has been chosen by Respira Technologies, Inc. to manufacture proprietary drug products for the world’s first inhaled smoking cessation therapy. This treatment uses RespiRx™, a vibrating mesh nebulizer (VMN) with a maintenance-free disposable cartridge that reduces and potentially eliminates the risk of patient misuse and non-compliance. 

Following a successful Pre-Investigational New Drug (IND) meeting with the Food and Drug Administration (FDA) on November 18, Respira is intending to submit their IND application in 2022 under the 505(b)(2) regulatory pathway.

Respira also plans to create a larger platform approach for active pharmaceutical ingredient (API) delivery, taking advantage of the multi-drug capabilities of their proprietary platform drug delivery system. To date, 91 potential APIs have been identified.

“Our team chooses best-in-class partners, and working with Altasciences has been a great experience overall. Altasciences is playing a big role in advancing Respira’s ambition to secure the FDA’s authorization on a potential breakthrough drug product, and through this collaborative environment, we can change the world of drug development. Altasciences is agile, flexible, and quick, while providing the proven expertise and capability required for cGMP pharma drug product manufacturing. We are thankful for their fast response rate, creativity, and ability to take on the needs of nimble start-ups like Respira,” said Mario Danek, Founder and CEO at Respira Technologies, Inc.

Altasciences leverages deep expertise in formulation, development, and manufacturing, as well as flexible processes and significant investments in state-of-the-art technologies, to support clients in their research and commercial manufacturing requirements.

“We are delighted to be partnering with Respira Technologies, Inc. on this new and exciting technology. Our team has truly enjoyed having the opportunity to work with a world-class organization that quickly makes key decisions to ensure we meet accelerated timelines,” stated Ben Reed, Executive Vice President of Operations at Altasciences.

More information on Respira Technologies, Inc.’s program can be found here.

About Altasciences

Altasciences is a forward-thinking, mid-size contract research organization offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services. For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. Altasciences’ integrated, full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, medical writing, biostatistics, clinical monitoring, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster.

Julie-Ann Cabana
Altasciences
+1 514 601-9763
jcabana@altasciences.com 

Laval, Quebec, December 9, 2021 – Altasciences is pleased to have been chosen by XORTX Therapeutics, Inc. to conduct a pharmacokinetic bridging study in support of the XRx-008 program for autosomal dominant polycystic kidney disease (ADPKD), and XRx-101 for acute kidney injury associated with COVID-19. XORTX’s novel, proprietary formulations of xanthine oxidase inhibitors are aimed at reducing uric acid levels in order to slow the progression of the genetic disorder ADPKD, and protect against acute kidney injury following COVID-19 infection.

The first of several clinical trials to characterize XORTX’s novel, proprietary formulations of xanthine oxidase inhibitors, its purpose is to determine whether the increased bioavailability of oxypurinol demonstrated for this formulation in preclinical studies will be replicated in humans.

 Dr. Allen Davidoff, President and CEO stated, “XORTX is pleased to be starting work with Altasciences as we initiate the characterization of our novel, proprietary formulations of xanthine oxidase inhibitors. This study marks the first of several clinical trials planned for the next year and an exciting opportunity to advance our kidney disease programs through preliminary characterization, followed by late stage registration trials.”

“With a pressing need for better therapeutic options and a global prevalence of kidney disease, we are proud to partner with XORTX for such an important study. We look forward to supporting this innovative company in their goal of bringing a valuable new treatment to the next stage, and getting better drugs to the people who need them, faster,” stated Ingrid Holmes, Vice President, Global Clinical Operations at Altasciences.

Altasciences offers a seamless drug development solution that allows sponsors to work with a single, integrated CRO/CDMO in support of early-phase research, from lead candidate selection to preclinical testing to clinical proof of concept in the most time- and cost-efficient way possible.

About Altasciences

Altasciences is an integrated drug development solution company offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services. For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. Altasciences’ integrated, full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, medical writing, biostatistics, clinical monitoring, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster.

Julie-Ann Cabana
Altasciences
+1 514 601-9763
jcabana@altasciences.com