Herantis Pharma announces FDA clearance of IND for Phase 2 study of Cis-UCA Eye Drops

Herantis Pharma announces FDA clearance of IND for Phase 2 study of Cis-UCA Eye Drops

Herantis Pharma plc.
Company release 8 September 2014 at 8:30 a.m.

The United States Food and Drug Administration (FDA) has cleared the Investigational New Drug application (IND) of Herantis Pharma Plc. for a Phase 2 clinical study of Cis-UCA Eye Drops for the treatment of Dry Eye Syndrome. Patient enrolment in the clinical study is planned to start by the end of 2014.

“Dry Eye Syndrome has surprisingly limited treatment options considering it is such a common eye disease”, says Burkhard Blank, MD, Chief Medical Officer of Herantis. “There is currently only one FDA-approved prescription drug in the market in the USA and none in the EU. We believe that Cis-UCA Eye Drops have the potential to provide an effective and safe treatment for many patients affected by Dry Eye Syndrome.”

The Phase 2 clinical study will be conducted at three investigational sites in the USA by Ora, Inc., the world’s leading independent, full-service ophthalmic clinical research and product development firm, who has worked with Herantis’ cis-UCA for the past three years. The study is designed to enrol a total of 150 patients randomized in three treatment groups receiving either placebo or one of two different doses of Cis-UCA Eye Drops, using Ora’s Controlled Adverse Environment (CAE) dry eye system. The objective of the study is to compare the safety and efficacy of Cis-UCA Eye Drops to placebo, for the treatment of the signs and symptoms of Dry Eye Syndrome.

“An estimated 45 million patients in the USA and in Europe suffer from Dry Eye Syndrome”, adds Pekka Simula, CEO of Herantis Pharma. “We are truly excited to reach this important milestone in our development of new, innovative drugs and look forward to helping patients in need of better treatments.”

Further information:

Herantis Pharma plc., Pekka Simula, CEO, telephone: +358 40 7300 445
Company web site: www.herantis.com
Certified Advisor: UB Capital Oy, telephone +358 9 2538 0225

About Dry Eye Syndrome

Dry Eye Syndrome (Keratoconjunctivitis sicca) is the most common cause of irritation in the eye. Typical subjective symptoms include dryness, burning sensation, pain, redness, and feeling of dirt in the eye. A severe or prolonged Dry Eye Syndrome may lead to complications causing damage to the surface of the eye and impaired vision. Dry Eye Syndrome is expected to become more prevalent with the aging population and with increasing use of computers and mobile devices.

About Cis-UCA Eye Drops

Cis-UCA Eye Drops is an ophthalmic solution indicated for the treatment of the signs and symptoms of Dry Eye Syndrome. Cis-urocanic acid (Cis-UCA), the active product ingredient of Cis-UCA Eye Drops, is an endogenous small molecule component of human and animal skin. It is constantly present in the human body and has been identified as a locally acting anti-inflammatory agent, which also reduces free radicals.

Cis-UCA Eye Drops has previously been investigated in an experimental model of dry eye in the mouse, conducted by Ora to simulate the CAE clinical model to be used in the Phase 2 clinical study. The results indicate that 1% Cis-UCA Eye Drops is efficacious in reducing corneal fluorescein staining in the model and performs better than the clinical comparator, Restasis®. Based on an earlier Phase 1 clinical study in 37 healthy volunteers, cis-UCA Eye Drops is expected to be safe and well tolerated in human subjects enrolled in the proposed Phase 2 clinical study.

About Herantis Pharma plc.

Herantis Pharma plc. is a pharmaceutical company specialised in new drug research and development. The company focuses on diseases with an unmet clinical need. These diseases include for example dry eye syndrome, Parkinson’s disease, and secondary lymphedema. We believe our drugs are the first or best in their class and have the potential to change treatment strategies of diseases. The shares of Herantis Pharma plc. are listed on the First North Finland marketplace run by NASDAQ OMX Helsinki stock exchange.