Herantis Pharma has initiated Phase 2 study with Cis-UCA Eye Drops in Patients
with Dry Eye Syndrome, results expected in Q3/2015
with Dry Eye Syndrome, results expected in Q3/2015
Herantis Pharma Plc. Company release 7 January 2015 at 9:00 am Herantis Pharma Plc. has initiated its Phase 2 clinical study with Cis-UCA Eye Drops in patients with Dry Eye Syndrome. In the study, 150 patients with Dry Eye Syndrome will be randomized to receive 4 weeks of treatment with either placebo eye drops or 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 will be conducted 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 on cis-UCA development for the past three years, including supporting requirements for clinical supply manufacturing, preclinical efficacy screening and regulatory guidance and interface. "Cis-UCA development program has progressed well thanks to a great team and strong commitment in the project by the involved parties", appreciates Pekka Simula, CEO of Herantis Pharma. "While the rate of patient recruitment is always difficult to estimate, our partner Ora, Inc. has developed an efficient system to study dry eye that directly combats the variability, such as slow patient recruitment, seen in these studies. We now believe that we can announce top- line data from the study already by September 2015." "An estimated 45 million patients in the USA and Europe suffer from Dry Eye Syndrome", adds Burkhard Blank, MD, Chief Medical Officer of Herantis. "The currently available symptomatic treatments do not provide sufficient relief in the inflammation related to most patients with Dry Eye Syndrome, where only one prescription drug has been approved by the FDA 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 who do not benefit from the existing drugs." Herantis Pharma aims to publish top-line data of the Phase 2 study by September 2015. The company had previously estimated that top-line results would be announced by the end of 2015. 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 being 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®. About drug development Drug development projects can usually be divided in clear phases: Preclinical phase, and clinical phase involving human subjects. The clinical phase 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.