Glenmark reports successful trial for nasal spray, to file NDA soon

Glenmark Pharmaceuticals, a global pharmaceutical company, today announced that its nasal spray Ryaltris met safety and efficacy goals in a Phase 3 clinical study in treating perennial allergic rhinitis.

With the positive results, the company said it plans to submit an application to the USFDA for treating seasonal allergic rhinitis in the first quarter of CY 2018.

Ryaltris, previously known as GSP 301, is a combination steroid plus antihistamine nasal spray.

“Ryaltris has been extensively studied in three Phase 3 trials for SAR, and we are pleased that the addition of this long-term study in patients suffering with PAR met the primary safety and secondary efficacy endpoints. Collectively, these data suggest that Ryaltris is effective and well-tolerated,” said Fred Grossman, President and Chief Medical Officer at Glenmark Pharmaceuticals.

Allergic rhinitis, also known as hay fever, is a type of inflammation in the nose which occurs when the immune system overreacts to allergens in the air. Signs and symptoms include a runny or stuffy nose, sneezing, red, itchy, and watery eyes, and swelling around the eyes.

“We have worked closely with the FDA on the clinical development program for Ryaltris, and look forward to providing robust data to support its potential approval.”

This Phase 3, U.S.-based trial was a three-arm, double-blind, randomized, parallel group, placebo-controlled safety study that enrolled 601 adults and adolescents 12 years of age and older with at least a two-year history of permanent allergic rhinitis.

Patients were randomized to 52 weeks of twice-daily treatment with Ryaltris, or two different formulations of a placebo nasal spray. All trial arms used the same nasal spray delivery system.

The study also assessed efficacy, as change from baseline in average morning patient-reported reflective Total Nasal Symptom Score (rTNSS), as a secondary endpoint, the company said.

For the primary endpoint, all treatments administered in the trial were well-tolerated, and the majority of treatment emergent adverse events were mild-to-moderate in severity.

The most frequent TEAEs reported with Ryaltris included nosebleeds (4.6%), headache (4.1%) and a decrease in taste sensitivity (2.0%).

In addition, on the secondary efficacy endpoint, treatment with Ryaltris demonstrated statistically significant and clinically meaningful improvement from baseline in average morning patient-reported reflective Total Nasal Symptom Score, compared to placebo (p<0.0001) over 52 weeks of treatment.

“Glenmark has rapidly evolved from a company with a thriving generic pharmaceutical business to one that is also discovering new treatments, and researching devices that deliver these treatments in new ways,” said Robert Matsuk, President, North America & Global API at Glenmark Pharmaceuticals.

“Ryaltris is an important first step in this evolution, and the realization of the potential in Glenmark’s pipeline has only just begun. Over the next 10 years, Glenmark believes that the investments made in the Company’s robust pipeline will continue to produce a variety of new and innovative treatment options.”

Data from this trial have not yet been published.

Glenmark will be submitting these data for presentation at upcoming scientific meetings and publication in a peer-reviewed journal. Besides rhinitis, Glenmark is also investigating treatments for asthma and chronic obstructive pulmonary disease (COPD).

It has five investigational treatments across the disease spectrum and devices, including GSP 304, currently in Phase 2 trials, which is a long-acting muscarinic receptor agonist being investigated as a nebulized treatment for COPD; GBR 310 (omalizumab), a proposed biosimilar candidate intended for the treatment of allergic asthma and chronic idiopathic urticaria; and GRC 39815, which is pre-clinically being investigated for the treatment of COPD.