Herantis Pharma announces FDA clearance of IND for Phase 2 study of Cis-UCA Eye Drops

Herantis Pharma Plc
Company release 08 Sep 2014 at 8:30 am
Herantis Pharma plc.
Company release 8 September 2014 at 8:30 a.m.

The   United   States  Food  and  Drug  Administration  (FDA)  has  cleared  the
Investigational  New Drug application (IND) of  Herantis Pharma Plc. for a Phase
2 clinical  study of Cis-UCA  Eye Drops for  the treatment of  Dry Eye Syndrome.
Patient enrolment in the clinical study is planned to start by the end of 2014.

"Dry  Eye Syndrome has surprisingly limited  treatment options considering it is
such  a common eye disease",  says Burkhard Blank, MD,  Chief Medical Officer of
Herantis.  "There is  currently only  one FDA-approved  prescription drug in the
market 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."

The  Phase 2 clinical study will be  conducted at three investigational sites 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'
cis-UCA for the past three years. The study is designed to enrol a total of 150
patients randomized in three treatment groups receiving either placebo or one of
two  different  doses  of  Cis-UCA  Eye  Drops,  using  Ora's Controlled Adverse
Environment  (CAE) dry eye system. 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.

"An  estimated 45 million patients in the USA  and in Europe suffer from Dry Eye
Syndrome",  adds Pekka Simula, CEO of Herantis  Pharma. "We are truly excited to
reach  this important milestone in our  development of new, innovative drugs and
look forward to helping patients in need of better treatments."

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 to be
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®. Based on an earlier
Phase 1 clinical study in 37 healthy volunteers, cis-UCA Eye Drops is expected
to be safe and well tolerated in human subjects enrolled in the proposed Phase
2 clinical study.

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 OMX Helsinki stock exchange.