Herantis Pharma’s Phase 2 Dry Eye study recruitment completed ahead of schedule

Herantis Pharma’s Phase 2 Dry Eye study recruitment completed ahead of schedule

Herantis Pharma Plc
Company release 11 March 2015 at 10:00 am

Herantis Pharma Plc has completed patient recruitment in its Phase 2 clinical study ahead of schedule. Also the number of recruited patients exceeded targets: A total of 161 patients were randomized in the study compared to the targeted 150 patients. The randomized patients will receive 4 weeks of treatment with either placebo eye drops or either of two different strengths of cis-UCA Eye Drops. 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.

This study is conducted in the USA by Ora, Inc., the world’s leading independent, full-service ophthalmic clinical research and product development firm.

“The study has proceeded extremely well”, appreciates Pekka Simula, CEO of Herantis. “Thanks to our seamless long-time collaboration and the experience of Ora in this field the patient recruitment exceeded our expectations both in terms of schedule and the number of patients randomized. A higher number of patients means stronger statistical significance of the results, which is a critical factor in this business.”

“This is a data driven industry”, reminds Burkhard Blank, MD, Herantis’ Chief Medical Officer. “We really look forward to the results of this study as they will eventually tell us whether our cis-UCA Eye Drops work for the treatment of Dry Eye, as we have a reason to believe based on preclinical efficacy data.”

Herantis Pharma intends to publish top-line data of the Phase 2 study during the second quarter of 2015. The company had previously estimated that top-line results would be announced by September 2015. If the results of the study are positive the company aims to proceed toward commercialization of cis-UCA Eye Drops for instance by negotiating a commercialization agreement with a global pharmaceutical company.

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, to simulate 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®. The reported sales of Restasis® in 2014 exceeded 1 billion US dollars.

About drug development

Drug development projects can usually be divided in two stages: The preclinical stage, and the clinical stage involving human subjects. The clinical stage can be further broken in three formal phases. Phase 1 clinical studies assess the safety of a drug candidate in human subjects. In Phase 2, the optimal dosing and possible efficacy in the treatment of a particular disease is studied. Phase 3 studies finally aim to establish a statistical proof of safety and efficacy of the drug candidate in typically hundreds or thousands of patients for market approval. Drug development can take 10-15 years from the first preclinical studies to market approval.

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 Helsinki stock exchange.