Herantis Pharma announces results from Phase 2 Cis-UCA Dry Eye study
Herantis Pharma Plc
Company release 3 June 2015 at 8:00 am
Herantis Pharma Plc has completed its initial analysis of the results of its Phase 2 clinical study of cis-UCA in Dry Eye disease. When compared to placebo, cis-UCA did not show statistically significant improvements in the two co-primary endpoints for the treatment of signs and symptoms of Dry Eye after four weeks of treatment.
Statistically significant efficacy was seen in some secondary endpoints.
In the clinical study, total of 161 patients were randomized to receive 4 weeks of treatment with either placebo eye drops or either of two different strengths of cis-UCA Eye Drops. Based on the results, cis-UCA was safe and as well tolerated as placebo.
"We want to thank the study subjects and investigators for their participation in the study", says Pekka Simula, CEO of Herantis. "We will continue to analyse the results of the study. In the meanwhile we will progress our two other main development programs, CDNF for a disease-modifying treatment of Parkinson's Disease, and Lymfactin for the treatment of secondary lymphedema."
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 indicated 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.