Realm Therapeutics submits second US drug application this year

Pending clearance, Realm will conduct trials focused on patients 10 years and older with allergic conjunctivitis, with a Phase II trial on the effectiveness of PR013 involving roughly 90 participants.

According to Realm's research, 30% of patients on the existing Ora-CAC treatment model do not adequately respond to the current standard of care, suggesting the possibility of PR013 offering a safer profile.

Market analysis undertaken by the company led them to estimate a peak sales potential of $400m annually for the drug on the US market.

Chief executive Alex Martin said, "This is our second IND filing in six months, and we are very pleased with the progress we have made following the announcement of our drug development strategy last year."

Following FDA clearance, he expects to begin the Phase II study later this year and to review the subsequent data on PR013's efficacy as a potential novel treatment for allergic conjunctivitis in the first half of 2018.

"If successful in clinical studies, PR013 will potentially provide a superior product to antihistamines and a safe and effective alternative to topical steroids, for children and adults suffering from this disease."

He added that the company remains on track to begin a Phase II study for PR022 in atopic dermatitis later this year.

As of BST 0945 Realm shares had crept forward 0.25p to 31p.