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Proteostasis Therapeutics Reports Fourth Quarter and Year-End 2019 Financial Results
and Provides Corporate Update
BOSTON, Mass. March 10, 2020 Proteostasis Therapeutics, Inc. (Nasdaq:PTI), a clinical stage biopharmaceutical company dedicated to the discovery and development of groundbreaking therapies to treat cystic fibrosis (CF) through theratyping, today announced financial results for the fourth quarter and full year ended December 31, 2019, and provided a corporate update.
Proteostasis made important progress throughout 2019 in delivering on our goal of bringing more treatment choices to patients with CF, said Meenu Chhabra, President and Chief Executive Officer of Proteostasis Therapeutics. With our Phase 2 trials complete, we are moving forward with a Phase 3 clinical development plan that embraces the pursuit of personalized medicine in CF through theratyping. Our mission is to deliver combinations of our investigational agents to preselected patients identified as responders to our therapies through the ex vivo testing of their own organoids. We believe that the theratyping path, or the process of matching CFTR modulators to individual CF patients based on a laboratory assay regardless of CFTR genotype, has the potential to become a patient-friendly and cost-effective approach to treatment for patients with CF, thereby increasing access to treatment options and optimizing risk-benefit and cost-effectiveness of CFTR modulators.
Ms. Chhabra continued, Through our next set of clinical trials that may be registrational trials, we will continue to explore the potential of our proprietary CFTR modulators - posenacaftor, dirocaftor and nesolicaftor - in rare and common CF mutations using both traditional and novel study approaches. We look forward to initiating these trials later this year and to providing updates, beginning with the CHOICES trial, soon thereafter.
Fourth Quarter and Recent Highlights
Last month, Proteostasis announced the completion of enrollment of 502 patients with CF in the HIT-CF Europe project, a research project which aims to provide better treatment and improve lives for people with CF and rare mutations. HIT-CF is leading a European-based initiative that is conducting confirmatory trials to assess the predictability of the organoid assay for clinical benefit, such as the CHOICES study (Crossover trial based on Human Organoid Individual response in CF - Efficacy Study). Proteostasis drug combinations will be tested first in an ex vivo study expected to be completed in the first half of 2020. Then, responders and non-responders will be selected for the CHOICES study. Dosing in CHOICES is expected to begin in the second half of 2020, with preliminary clinical data anticipated to be reported in early 2021.
In January of this year, Proteostasis announced a regulatory update following the completion of a scientific advice meeting with the Medicines and Healthcare Products Regulatory Agency in the United Kingdom (MHRA) that outlined a path forward for the initiation and execution of our Phase 3 program and the potential filing of a Marketing Authorization Application for posenacaftor, dirocaftor and nesolicaftor. The Company announced that it will continue to seek additional advice from other major regulatory agencies throughout 2020.
The following information was filed by Proteostasis Therapeutics, Inc. (PTI) on Tuesday, March 10, 2020 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.
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