CLEAN-CF Clinical Trial Expanded to Include Pediatric Cystic Fibrosis Population

Drug Safety Monitoring Board Recommends Expansion of Trial Population to Include 12 to 17 Year Old People with CF

Durham, NC (September 10, 2015) – Parion Sciences, a company dedicated to the development of novel treatments for pulmonary and ocular diseases, announced today that the CLEAN-CF enrollment criteria for the study of P-1037 would be expanded to include people with Cystic Fibrosis (CF) between the ages of 12 and 17 years of age. The trial had previously enrolled people with CF age 18 and above only. The expansion of the age criteria for enrollment was based on a pre-specified safety review by the Data Monitoring Committee (DMC).

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Vertex and Parion Sciences Establish Collaboration to Develop Epithelial Sodium Channel (ENaC) Inhibitors in Cystic Fibrosis and Other Pulmonary Diseases

 – ENaC inhibition aims to restore or improve hydration of cell surfaces in the lungs to improve lung function –

– Parion to receive $80 million up-front payment with potential for additional development and regulatory
milestones and royalty payments –

BOSTON and DURHAM, NCVertex Pharmaceuticals Incorporated (Nasdaq: VRTX) and Parion Sciences today announced that the companies will collaborate to develop investigational epithelial sodium channel (ENaC) inhibitors for the potential treatment of cystic fibrosis (CF) and other pulmonary diseases. Under the agreement, Vertex gains worldwide development and commercial rights to Parion’s investigational ENaC inhibitors, including P-1037 and P-1055, for CF and other pulmonary diseases. P-1037 is currently being evaluated in an exploratory Phase 2a study in people with CF, regardless of genotype, and Vertex and Parion plan to begin an additional Phase 2a study that adds P-1037 to treatment with the investigational combination of lumacaftor and ivacaftor for people with CF who have two copies of the F508del mutation. Parion will receive an $80 million up-front payment from Vertex with the potential to receive additional development and regulatory milestone payments and tiered royalties related to P-1037 and P-1055 in CF and other pulmonary diseases.

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Parion Sciences Receives 2015 Life Sciences Award as “Best Late Stage Product Development” Company

Parion selected for Award by the Triangle Business Journal and BDO

Durham, NC (May 22, 2015) – Parion Sciences, a company dedicated to the development of novel treatments for pulmonary and ocular diseases, announced today that it was awarded the Best Late Stage Product Development Company award by the Triangle Business Journal and accounting firm BDO. Parion joins the third-annual class of Life Science Award winners and received the award at an event held yesterday in Cary North Carolina. The Life Sciences awards recognize both individuals and research organizations that are breaking ground in the field. This encompasses a number of areas, including biology, biotechnology, genomics, neuroscience, and pharmacology.

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Parion Sciences Announces Key Management Promotion

Board of Directors Elect Paul Boucher as President and Chief Executive Officer

Durham, NC (April 19, 2015) – Parion Sciences, a company dedicated to the development of novel treatments for pulmonary and ocular diseases, announced today that Paul Boucher has been promoted to President and Chief Executive Officer. Paul previously served as President of Parion and will assume the Chief Executive Officer role as well.   Prior to his President role, Paul served as Vice-President of Finance & Business at Parion. Paul will continue to lead the executive management team and provide overall corporate direction.

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Parion Sciences Announces Initiation of Phase 2 Clinical Study of P-1037 for the Treatment of Cystic Fibrosis

First Patient with Cystic Fibrosis Enrolled in CLEAN-CF Phase 2 Clinical Trial

Durham, NC (May 6, 2015) – Parion Sciences, a company dedicated to the development of novel treatments for pulmonary and ocular diseases, announced today it has begun enrollment of a phase 2 clinical trial of P-1037 in patients with Cystic Fibrosis (CF).

The trial has been named the “CLEAN-CF” trial which refers to “Clearing Lungs with ENaC inhibition in Cystic Fibrosis”. The CLEAN-CF study will include CF patients regardless of an individual’s genetic mutation. Inhibiting the epithelial sodium channels (ENaC) in the airways with P-1037, an “ENaC blocker,” is expected to re-hydrate the mucus layers, thus restoring airway clearance, improve lung function and, ultimately, reduce exacerbations. P-1037 has demonstrated to be long acting in preclinical models and to have a favorable safety and tolerability profile in the completed Phase 1 studies. The initiation of the Phase 2 clinical trials was supported by an award from Cystic Fibrosis Foundation Therapeutics Inc. (CFFT), the nonprofit affiliate of the Cystic Fibrosis Foundation.

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Parion’s $19.6M Inflow To Help Many Breathe Easier

Mucus.

Non-adolescents generally don’t think much about it until they’re suffering from allergies or a cold. For most people, you might say, ‘snot a big deal.

But a layer of protective mucus in sensitive bodily tissues plays a critical role in keeping our bodies healthy. People who have mucosal surface deficiencies suffer from conditions ranging from dry eye disease to life-threatening pulmonary diseases, including cystic fibrosis (CF), chronic obstructive pulmonary disease, and idiopathic pulmonary fibrosis.

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