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.