Herantis Pharma granted almost 3 million Euro government loan for Parkinson study
Herantis Pharma Plc
Company release 30 June 2015 at 10:00 am
Tekes, the Finnish Funding Agency for Innovation, has granted a 2,903,000 EUR R&D loan to Herantis Pharma Plc to support its clinical study of CDNF for the treatment of Parkinson's disease. The loan was granted conditionally subject to obtaining regulatory approval for the clinical study.
"Tekes funding enables us to conduct this study with an optimal design", appreciates Sigrid Booms, Herantis' Director of Clinical Development. "While that is really valuable for the company it is even more so for patients participating in this study, who can be provided with the best possible chance to benefit from the investigational drug."
"Anyone diagnosed with Parkinson's disease, or close to a person who is, knows how significant impact this incurable disease has on one's quality of life", reminds Pekka Simula, CEO of Herantis Pharma. "We are very excited about our opportunity to translate the results of years of leading academic research to clinical stage, hopefully for the benefit of as many patients as possible."
Herantis aims to start its clinical development program with regulatory submissions in Finland and Sweden by the end of 2015. Patient treatments are expected to begin in the first half of 2016. The company expects to recruit 18 patients with Parkinson's disease in this first-in-human study of CDNF.
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 2538 0254
About Parkinson's Disease
Parkinson's disease is a slowly progressing neurodegenerative disease caused by the death of dopaminergic neurons in the brains. Common first 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, Parkinson's disease may cause non-motor symptoms such as sleep problems, depression, and anxiety, which are not alleviated by current Parkinson drugs. Estimated 7 million people worldwide have Parkinson's disease.
CDNF, or Cerebral Dopamine Neurotrophic Factor, is a neuroprotective and neurotrophic protein patented worldwide by Herantis. Following a preclinical development program, which has showed it as efficacious in several preclinical models of Parkinson's disease, Herantis is preparing for a first-in-human clinical study of CDNF in the treatment of Parkinson's disease.
In the preclinical studies, CDNF has both protected and regenerated dopamine-generating cells suggesting a potential for disease modification of Parkinson's disease. Signals of efficacy are also seen in non-motor symptoms. This suggests that CDNF has the potential to address two clinical needs yet unmet by any known therapies.
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.