Specialty pharmaceutical company Optinose Inc. (OPTN:NASDAQ), which is engaged in the development of therapeutics and medical products utilized in caring for patients treated by allergy specialists and ear, nose, and throat (ENT) doctors, today announced "the statistically significant benefits of XHANCE in the ReOpen2 trial for both the symptoms co-primary endpoint and the CT scan co-primary endpoint."
Optinose stated that in the global Phase 3 ReOpen2 XHANCE trial, patients who had been diagnosed with chronic sinusitis (CS) but did not have nasal polyps, demonstrated significant improvement when treated with both doses of XHANCE® (fluticasone propionate) nasal spray together with the company's Bi-Directional™ Exhalation Delivery System™ versus patients in the controlled (placebo) group. The firm highlighted that the study represents the first Phase 3 initiative to ever show improvement in both symptoms and inflammation inside the sinuses with a nasal therapy for CS patients.
Optinose's President Ramy Mahmoud, M.D., M.P.H. commented, "ReOpen2 is a large, international, controlled trial, studying 222 patients with chronic sinusitis who did not also have nasal polyps. Currently there are no FDA-approved drug treatments for this large patient population…With top-line results showing that patients with chronic sinusitis experienced significant improvement in both symptoms and inflammation inside the sinuses, ReOpen2 confirms and builds on the positive results from ReOpen1 and, importantly, provides evidence supporting the effectiveness of XHANCE in the very large chronic sinusitis population without nasal polyps."
"Our team is working to quickly complete the analyses of both ReOpen1 and ReOpen2 and has begun the work necessary to seek a new indication that expands access to XHANCE for this broader group of patients," Dr. Mahmoud added.
Rick Chandra, M.D., Professor of Otolaryngology, Chief of Rhinology, Sinus & Skull Base Surgery at Vanderbilt University, remarked, "I see patients every day who suffer greatly from the symptoms of chronic sinusitis, despite availability of current nasal treatments. I am excited to see this important confirmatory data showing the benefits of XHANCE in this challenging population. This evidence has potential to change the treatment paradigm for chronic sinusitis patients."
The firm mentioned that the Phase 3 ReOpen2 trial is a randomized, double-blind study designed to evaluate the safety and efficacy of XHANCE (OPN-375) in patients with chronic sinusitis (CS) without nasal polyps. CS patients in the study were treated over a period of 24 weeks and were administered either one or two sprays of XHANCE in each nostril twice daily.
The company listed that the two predetermined primary endpoints in the trial were "change from baseline in symptoms, as measured by a composite score of patient-reported symptoms (including nasal congestion, facial pain or pressure sensation, and nasal discharge) at the end of week 4, and objective change in inflammation inside the sinus cavities, as measured by the change in average of percentages of volume occupied by disease across the ethmoid and maxillary sinuses as measured by CT scan."
The company explained it is estimated that that up to thirty million adults in the U.S. are affected by CS. The firm advised that CS is a chronic and serious inflammatory disease affecting the paranasal sinuses and the nasal cavity at the point where healthy sinus openings ventilate and drain. Patients diagnosed with CS typically exhibit prolonged symptoms that persist for a period of at least 12 weeks, with most experiencing symptoms lasting for many years. In some patients, the condition can be accompanied by nasal polyposis, polyps that have developed in the nasal cavities. The company stated that at present there are not any FDA-approved drug treatments for CS; however, there are certain medicines such as XHANCE that have received FDA approval for treatment of nasal polyps.
Optinose is a specialty pharmaceutical firm based in Yardley, Pa. that concentrates its efforts on developing and commercializing innovative products and medicines for individuals who are afflicted with diseases that are treated by allergists and ear, nose and throat (ENT) specialists. Optinose stated that "XHANCE is a drug-device combination product that uses the Exhalation Delivery System™ (also referred to as the EDS®) designed to deliver a topical anti-inflammatory corticosteroid to the high and deep regions of the nasal cavity where sinuses ventilate and drain." In addition, the company licenses its Onzetra® Xsail®, a sumatriptan nasal powder indicated for acute treatment of migraine with or without aura in adults, to Currax Pharmaceuticals for sale in the U.S. Canada and Mexico.
Optinose Inc. started the day with a market cap of around $153.0 million with approximately 82.7 million shares outstanding and a short interest of about 2.4%. OPTN shares opened 16% higher today at $2.15 (+$0.30, +16.22%) over Friday's $1.85 closing price. The stock has traded today between $2.00 and $2.83 per share and is currently trading at $2.59 (+$0.74, +40.00%).
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