Optinose Announces Peer-Reviewed Publication of the Fourth Major XHANCE Registration Trial

/EIN News/ -- YARDLEY, Pa., Dec. 17, 2019 (GLOBE NEWSWIRE) -- Optinose (NASDAQ:OPTN), a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists, today announced that results of the Phase 3 EXHANCE-3 trial were published in the peer-reviewed journal Rhinology¹, the official journal of the International Rhinologic Society.  

“We are pleased to announce the publication of EXHANCE-3, the fourth major registration trial from the development program supporting the initial FDA approval of XHANCE,” said Ramy Mahmoud, M.D., M.P.H., President and Chief Operating Officer of Optinose. “The Optinose team would like to thank the investigators and patients who made this trial possible. Data from this trial contributes importantly to understanding the clinical performance of XHANCE and would not be available today without their willingness to participate.”  Dr. Mahmoud went on to note, “The comparable results on measures of efficacy observed in the EXHANCE studies between CS patients with and without nasal polyps increases our enthusiasm for our ongoing Phase 3b program, which is intended to pave the way toward the first FDA drug approval for the treatment of chronic sinusitis, a common and high-morbidity illness.”    

EXHANCE-3 was part of a comprehensive development program including five clinical trials evaluating XHANCE^® (fluticasone propionate) nasal spray in over 1,500 adult patients; including two randomized, double blinded, placebo controlled Phase 3 pivotal clinical trials in adults with nasal polyposis [NAVIGATE I and II] and two supportive open label Phase 3 clinical trials in adults with symptoms of chronic sinusitis with or without nasal polyps [EXHANCE-3 and -12]. Based upon the results of this program, the U.S. Food & Drug Administration (FDA) approved XHANCE for the treatment of nasal polyps in patients 18 years of age and older in September 2017.

About EXHANCE-3¹

EXHANCE-3 was a prospective, multicenter, 12-week, single-arm study evaluating the safety and efficacy of XHANCE 372 mcg twice daily in chronic sinusitis (CS) patients with or without nasal polyps. Eligible patients were 18 years of age or older and met diagnostic symptom criteria for CRS. In this study, 705 subjects were enrolled with 92.3% of patients reporting having previously tried corticosteroids and 27.5% reporting prior sinus surgery. All patients received XHANCE 372 mcg twice daily.

The majority of spontaneously reported AEs were local in nature, mild in severity, and resolved spontaneously with continued use of XHANCE. The most common AEs (>5%) included nasal mucosal disorder (10.2%), spontaneously reported epistaxis (6.8%), nervous system disorder (5.7%), and nasal septum disorder (5.5%).

Important efficacy measures in EXHANCE-3 included:

• Sinonasal Outcome Test‑22: At month 1, mean SNOT-22 total scores improved from baseline, with similar improvement in participants with nasal polyps or without nasal polyps of approximately 20 and 21 points, or 46% and 48% respectively. SNOT-22 scores improved more with longer duration of treatment through Month 3.
   
• Complete Response Analysis: After 3 months of treatment with XHANCE, approximately 48% of the patients who started the study with polyps were observed to have polyp elimination (polyp grade of zero) in at least one nostril.
   
• Patient Global Impression of Change: At month 3, 92% of patients with nasal polyps and 89% without nasal polyps reported improvement and 74% with nasal polyps and 68% without nasal polyps reported being ‘‘much’’ or ‘‘very much’’ improved.

Other efficacy measures indicating improvement in this study included Lund‐Kennedy endoscopic scoring of observed nasal pathology, indicators of potential need for surgery, and others. 

About CRS with and without nasal polyps
Chronic rhinosinusitis (CRS) is a chronic inflammatory condition affecting an estimated 10%-15% of the population. Chronic rhinosinusitis is divided into two common subtypes: with or without nasal polyps (CRSwNP, CRSsNP). Nasal polyps are benign lesions developing from the chronically inflamed surfaces deep in the nose.

About XHANCE
XHANCE (fluticasone propionate) nasal spray, 93 mcg is an exhalation delivery system combined with an anti-inflammatory corticosteroid and is currently indicated for the treatment of nasal polyps in patients 18 years of age or older. XHANCE combines a proprietary Optinose Exhalation Delivery System (EDS) for liquids with an aqueous suspension of microfine fluticasone propionate for topical intranasal administration

IMPORTANT SAFETY INFORMATION for XHANCE

CONTRAINDICATIONS:
Hypersensitivity to any ingredient in XHANCE.

WARNINGS AND PRECAUTIONS:

• Local Nasal Effects: epistaxis, erosion, ulceration, septal perforation, Candida albicans infection, and impaired wound healing. Monitor patients periodically for signs of possible changes on the nasal mucosa. Avoid use in patients with recent nasal ulcerations, nasal surgery, or nasal trauma.
• Close monitoring for glaucoma and cataracts is warranted.
• Hypersensitivity reactions (e.g., anaphylaxis, angioedema, urticaria, contact dermatitis, rash, hypotension, and bronchospasm) have been reported after administration of fluticasone propionate. Discontinue XHANCE if such reactions occur.
• Immunosuppression: potential increased susceptibility to or worsening of infections (e.g., existing tuberculosis; fungal, bacterial, viral, or parasitic infection; ocular herpes simplex). Use with caution in patients with these infections. More serious or even fatal course of chickenpox or measles can occur in susceptible patients.
• Hypercorticism and adrenal suppression may occur with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue XHANCE slowly.
• Assess for decrease in bone mineral density initially and periodically thereafter.

ADVERSE REACTIONS:
The most common adverse reactions (incidence ≥ 3%) are epistaxis, nasal septal ulceration, nasopharyngitis, nasal mucosal erythema, nasal mucosal ulcerations, nasal congestion, acute sinusitis, nasal septal erythema, headache, and pharyngitis.

DRUG INTERACTIONS:
Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir, ketoconazole): Use not recommended. May increase risk of systemic corticosteroid effects.

USE IN SPECIFIC POPULATIONS
Hepatic impairment. Monitor patients for signs of increased drug exposure.

INDICATIONS AND USAGE:
XHANCE is a corticosteroid indicated for the treatment of nasal polyps in patients 18 years of age or older.

Please see full Prescribing Information at www.xhance.com.

About Optinose
Optinose is a global specialty pharmaceutical company focused on serving the needs of patients cared for by ear, nose and throat (ENT) and allergy specialists. Optinose has offices in the U.S., the U.K. and Norway. To learn more, please visit www.optinose.com or follow us on Twitter and LinkedIn.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. All statements that are not historical facts are hereby identified as forward-looking statements for this purpose and include, among others, statements relating to the Company’s clinical program of XHANCE for chronic sinusitis; the potential for XHANCE to be the first FDA approved drug product for chronic sinusitis; enthusiasm for ongoing Phase 3b program for chronic sinusitis due to results observed in the EXHANCE studies in CRS patients with and without nasal polyps; and other statements regarding the Company's future operations, prospects, objectives and other future events. Forward-looking statements are based upon management’s current expectations and assumptions and are subject to a number of risks, uncertainties and other factors that could cause actual results and events to differ materially and adversely from those indicated by such forward-looking statements including, among others: ; uncertainties and delays relating to the initiation, enrollment, completion and results of clinical trials; potential for varying interpretation of clinical trial results; risks and uncertainties relating to FDA approval; and the risks, uncertainties and other factors discussed under the caption "Item 1A. Risk Factors" and elsewhere in our most recent Form 10-K and Form 10-Q filings with the Securities and Exchange Commission - which are available at www.sec.gov. As a result, you are cautioned not to place undue reliance on any forward-looking statements. Any forward-looking statements made in this press release speak only as of the date of this press release, and we undertake no obligation to update such forward-looking statements, whether as a result of new information, future developments or otherwise.

References

1 – Sher MR, Steven GC, Romett JL, Pien G, LeBenger K, Messina JC, Carothers JL, Mahmoud RA,  Djupesland PG, EXHANCE-3: a cohort study of the exhalation delivery system with fluticasone for chronic sinusitis with or without nasal polyps,  Rhinology, https://doi.org/10.4193/Rhin19.124.

Optinose Investor Contact
Jonathan Neely
jonathan.neely@optinose.com
267.521.0531