Herantis Pharma Phase 1 study results of Cis-UCA Eye Drops published

Herantis Pharma Phase 1 study results of Cis-UCA Eye Drops published

Herantis Pharma Plc.
Company release 26 January 2015 at 10:00 am

Results of the Phase 1 clinical study of Cis-UCA Eye Drops of Herantis Pharma have been published in the scientific journal Acta Ophthalmologica. The peer-reviewed article concludes that topical ocular administration of cis-UCA Eye Drops three times a day for 14 days is safe and well tolerated in healthy adults.

"It is always rewarding to have a drug candidate's safety - one of its essential attributes - confirmed through publishing in an international peer-reviewed journal", says Burkhard Blank, MD, Herantis' Chief Medical Officer. "It is exceptionally exciting that it coincides with the recent initiation of our consecutive Phase 2 efficacy study."

"We really value the expertise and high quality of research conducted at the University of Eastern Finland", adds Henri Huttunen, PhD, Herantis' Chief Scientific Officer. "The entire Cis-UCA development program is a great example of what can be achieved through a good university-industry collaboration - a cornerstone of Herantis."

The published article titled "A randomized phase I clinical study of cis-urocanic acid eye drops in healthy adult subjects" will appear in Acta Ophthalmologica and is now available online ahead of printing under the identifier: doi: 10.1111/aos.12651.

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®.

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.