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Blog Exposure - FDA Granted Fast Track Designation to Proteostasis Therapeutics’ Triple Combination Program for Cystic Fibrosis

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LONDON, UK / ACCESSWIRE / April 6, 2018 / Active-Investors.com has just released a free research report on Proteostasis Therapeutics, Inc. (NASDAQ: PTI). If you want access to this report all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=PTI as the Company's latest news hit the wire. On April 04, 2018, the Cambridge-based Company announced that the US Food and Drug Administration (FDA) has granted Fast Track Designation for the Company's triple combination program for the treatment of cystic fibrosis (CF). Register today and get access to over 1,000 Free Research Reports by joining our site below:


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Active-Investors.com is focused on giving you timely information and the inside line on companies that matter to you. This morning, Proteostasis Therapeutics most recent news is on our radar and our team decided to put out a fantastic report on the company that is now available for free below:


The proprietary triple combination includes a novel cystic fibrosis transmembrane conductance regulator (CFTR) amplifier, third generation corrector, and potentiator, known as PTI-428, PTI-801, and PTI-808, respectively.

Combinations of CFTR Modulators Hold the Promise of Improving Treatment Efficacy for Different Segments of CF Population

Meenu Chhabra, President, and CEO of Proteostasis Therapeutics stated that fast track designation, together with other recent designations from regulators and CF organizations following review of the Company's results with PTI-428, PTI-801, and PTI-808, is recognition of the potential of these programs in this disease. Meenu added that combinations of CFTR modulators hold the promise of improving treatment efficacy for different segments of the CF population, including F508del heterozygotes and F508del homozygotes, where patients have limited access to treatment, are underserved by existing treatments or see a declining benefit in lung function over time.

The news report suggests that post announcement of the news, shares of the Company surge in the pre-market trading.

Proteostasis' Proprietary Triple Combination Therapy Study Protocol Received Endorsement from the Largest CF Patient Advocacy Groups in the US and Europe

On January 08, 2018, the Company announced that the protocol for its triple combination clinical study has received endorsement and a high strategic fit score from the Therapeutics Development Network (TDN) and the Clinical Trial Network (CTN), the drug development arms of the Cystic Fibrosis Foundation (CFF), and the European CF Society (ECFS), respectively. The study is designed to investigate the safety, tolerability, and pharmacokinetics (PK) of the co-administration of PTI's CFTR modulators, PTI-428, PTI-801, and PTI-808, and will also assess lung function (FEV). Proteostasis Therapeutics plans to initiate the dosing of CF patients in first half of 2018.

FDA Granted Orphan Drug Designation & Breakthrough Therapy Designation for PTI-428 in CF

On March 14, 2018, the FDA granted Orphan Drug Designation for PTI-428, Proteostasis Therapeutics' CFTR amplifier drug candidate. On March 12, 2018, FDA also granted Breakthrough Therapy Designation for PTI-428 for the treatment of CF in homozygous patients for the F508del mutation who are receiving Orkambi® as background therapy. The FDA Office grants Orphan Drug Designation to novel drugs or biologics that are intended for the treatment of rare diseases or conditions affecting fewer than 200,000 patients in the US.

About Cystic Fibrosis

CF is a genetic disorder that affects mostly the lungs, but also the pancreas, liver, kidneys, and intestine. Long-term issues include difficulty breathing and coughing up mucus as a result of frequent lung infections. Other signs and symptoms of CF may include sinus infections, poor growth, fatty stool, clubbing of the fingers and toes, and infertility in most males. Different people may have different degrees of symptoms. There is no known cure for CF.

About Triple Combination Therapy

Proteostasis Therapeutics is developing a combination treatment for CF through co-administration of three separate CFTR modulators: PTI-428, PTI-801, and PTI-808. All three drug candidates were discovered internally at the Company and are designed to act synergistically through complementary mechanisms of action which address specific dysfunctions of the CFTR protein, the underlying cause of the disease.

About Proteostasis Therapeutics, Inc.

Founded in 2006 and headquartered in Cambridge, Massachusetts, Proteostasis Therapeutics, Inc. is a clinical-stage biotechnology company discovering and developing novel small molecule therapeutics designed to modulate the Proteostasis Network and restore the body's protein homeostasis. The Proteostasis Network maintains the body's natural balance of proteins and protects us from numerous diseases.

Stock Performance Snapshot

April 05, 2018 - At Thursday's closing bell, Proteostasis Therapeutics' stock fell 3.38%, ending the trading session at $4.58.

Volume traded for the day: 1.14 million shares.

Stock performance in the last month – up 35.91%; and previous six-month period – up 112.04%

After yesterday's close, Proteostasis Therapeutics' market cap was at $152.93 million.

The stock is part of the Technology sector, categorized under the Application Software industry. This sector was up 0.3% at the end of the session.


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