EU funding application coordinated by Herantis Pharma has passed evaluation phase
Herantis Pharma Plc
Company release 8 Aug 2016 at 9:00 am
The European Commission has informed that the EU funding application TreatER, coordinated by Herantis Pharma Plc (“Herantis”), has passed the evaluation phase and is invited to start grant preparation. This does not yet constitute a formal commitment for funding. The final decision by the European Commission depends on the finalisation of grant preparation and the rest of the selection procedure.
The application concerns the company’s planned first clinical study of CDNF in Parkinson’s disease. The grant application is titled “Clinical study in Parkinson’s disease with two unique goals: 1) Proof-of-concept of CDNF protein for disease modification; 2) Validation of clinically tested device for intracerebral drug delivery” and the requested grant from the Horizon 2020 Framework Programme amounts to approximately €6 million.
Herantis expects to disclose the final result of the grant preparation by the end of 2016. If the funding is granted Herantis expects it to clearly improve the company’s financial position.
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 25 380 246
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’s drugs. Estimated 7 million people worldwide have Parkinson’s disease.
CDNF, or Cerebral Dopamine Neurotrophic Factor, is an endoplasmic reticulum located and secreted protein with neuroprotective and neurorestorative properties, patented worldwide by Herantis. Following a preclinical development program, which has showed it as efficacious in several preclinical models of Parkinson’s disease (PD), Herantis is preparing for a first-in-human clinical study of CDNF in the treatment of PD and has a preclinical development program for the treatment of ALS.
In preclinical studies including chronic toxicology studies, CDNF administration has been safe; CDNF has protected and regenerated midbrain dopamine-generating cells suggesting a potential for disease modification of PD; it has also shown efficacy in non-motor symptoms in 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 is based on research at the Institute of Biotechnology 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 a drug development company focused on early clinical development of innovative drugs in unmet clinical needs. Our special emphasis is in regenerative medicine where the company has two first-in-class assets based on globally leading science in their fields: CDNF for neurodegenerative diseases, primarily Parkinson’s and ALS; and Lymfactin® for breast cancer associated lymphedema, with potential also in primary lymphedema. The shares of Herantis are listed on the First North Finland marketplace run by Nasdaq Helsinki stock exchange.