DURHAM … Inspire Pharmaceuticals (Nasdaq: ISPH) says the results of a Phase II clinical trial for INS37217 Intranasal in patients with perennial allergic rhinitis (PAR) demonstrated improvement for symptoms, including nasal blockage and stuffiness, facial pain and pressure, post nasal drip and runny nose.
These positive results were observed across multiple days at multiple doses in the six-day study. In addition, statistically significant improvement compared to placebo was shown at the end of the study in the mid-dose group, which performed best in Phase I.
INS37217 Intranasal was delivered as a non-preserved nasal spray administered twice daily. The trial was conducted in 59 subjects with symptomatic PAR, also referred to as chronic rhinitis. The safety data from the study indicate that INS37217 Intranasal is well tolerated by patients. No serious, drug-related adverse events were reported, and no
patients withdrew from the trial.
“The results of this Phase II study confirm the findings from our Phase I study, in which we demonstrated clear pharmacological activity in study subjects with a history of PAR,” Chief Executive Christy Shaffer said in a statement. “The safety profile we have seen thus far, along with these strong efficacy results in highly symptomatic patients, support moving quickly into a Phase II/III program. Among our five active development programs, the intranasal and dry eye programs remain our highest priorities, and we will continue to advance these most aggressively.”
Allergic rhinitis is a condition that results from exposure to allergens, either at specific times of the year (seasonal allergic rhinitis) or year-round (PAR). In either seasonal or PAR, the symptoms and treatment approaches are similar. Symptoms most often include nasal congestion or stuffiness, runny nose and nasal itching. The condition affects nearly 150 million people in the world’s seven major pharmaceutical markets, and annual sales of prescription products to treat allergic rhinitis are estimated to total more than $4.5 billion worldwide.
INS37217 Intranasal is believed to be potentially useful across a variety of upper respiratory disorders involving impaired clearance, including rhinosinusitis, allergic rhinitis (both seasonal and perennial) and upper respiratory viral infections. In addition to the Phase II study in patients with PAR, Inspire has an ongoing Phase II study of INS37217 Intranasal in patients with upper respiratory infection. Results of that study are expected within one to two months.
Inspire Pharmaceuticals: www.inspirepharm.com