Herantis Pharma has initiated patient recruitment

Herantis Pharma has initiated patient recruitment and consented first patient in CDNF study in Parkinson's disease

Herantis Pharma Plc Company release 27 Sep 2017 at 9:00 am

Herantis Pharma Plc ("Herantis") has initiated patient recruitment in the first-in-human clinical study of the company's investigational product CDNF for the treatment of Parkinson's disease. The first study site, Karolinska University Hospital in Stockholm, Sweden, has already consented the first patient in the study.

"It is highly rewarding to reach this milestone after years of determined effort by our team, and more than a decade of research by professor Mart Saarma 's group at the University of Helsinki", praises Sigrid Booms , Herantis' Director, Clinical Development.

"Anyone could develop Parkinson's disease, which causes suffering in millions of patients and is an immensely expensive chronic disease for societies. New hope of slowing or even stopping disease progression is highly welcome", adds Pekka Simula , Herantis' CEO. "We are very proud to now have two clinical studies ongoing with our innovative assets in regenerative medicine, based on globally leading science and aiming at breakthrough in unmet clinical needs: In Parkinson's disease, and in Secondary lymphedema."

Two further study sites, Helsinki University Hospital in Finland and Lund University Hospital in Sweden, are planned to initiate patient recruitment as soon as the required safety data cumulate from the first study site. This is estimated to take place in the first quarter of 2018. Further information on the clinical study is available on the project's web site at https://treater.eu/ .

The clinical study intends to recruit in total 18 patients with Parkinson's disease. A subset of the patients will be administered a placebo infusion instead of CDNF. This study setup supports a more objective initial assessment of the safety and effects of CDNF. The participating patients will also be offered the possibility to participate in an extension study in which all patients will receive CDNF, subject to regulatory approvals of the extension study.

Further information:

Herantis Pharma Plc, Pekka Simula, CEO, telephone: +358 40 7300 445 Company web site: www.herantis.com Certified Advisor: UB Securities Ltd, telephone: +358 9 25 380 225

About Parkinson's disease

Parkinson's disease (PD) is a slowly progressing, incurable neurodegenerative disease caused by the death of dopaminergic neurons in the midbrain. Common first motor symptoms of the disease include tremors, rigidity and slowness of movement. While the motor symptoms can be treated with medication the disease progression cannot be prevented, and the benefits of medication may be lost with disease progression or side effects can become unmanageable. In addition, PD may cause non-motor symptoms such as sleep problems, depression, and anxiety, which are not alleviated by current Parkinson's drugs. It is estimated that 7 million people worldwide suffer from Parkinson's disease.

About CDNF

CDNF is a novel drug candidate for the treatment of neurodegenerative diseases. Naturally present in the human blood circulation and cerebrospinal fluid, CDNF is a protein with neuroprotective and neurorestorative properties, patented worldwide by Herantis.  Encouraged by strong preclinical proof-of-concept Herantis has launched a first-in-human, randomized Phase 1-2 clinical study with CDNF for the treatment of Parkinson's disease. The clinical study has received funding from the European Union's research and innovation program Horizon 2020 under grant agreement number 732386.

CDNF administration has been safe in preclinical studies including chronic toxicology studies; CDNF has protected and regenerated midbrain dopamine-generating cells suggesting potential for disease modification of PD. It has also shown efficacy in non-motor symptoms of PD. In an ALS disease model CDNF has significantly increased survival and reduced symptoms. This suggests the potential to address unmet clinical needs in both PD and ALS. CDNF drug development is based on research at the University of Helsinki, lead by professor Mart Saarma .

About drug development in general

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 an innovative drug development company focused on regenerative medicine for breakthrough in unmet clinical needs. Our first-in-class assets are based on globally leading scientific research in their fields: CDNF for disease modification in neurodegenerative diseases, primarily Parkinson's and ALS; and Lymfactin® for breast cancer associated lymphedema, with potential also in other lymphedemas. The shares of Herantis are listed on the First North Finland marketplace run by Nasdaq Helsinki stock exchange.

Distribution:

Nasdaq Helsinki Main media www.herantis.com