The research and innovation program of the European Union, Horizon 2020, has awarded a grant of approximately €6.0 million for Herantis Pharma Plc’s (“Herantis”) Phase 1-2 clinical study with Herantis’ drug candidate CDNF for the treatment of Parkinson’s disease (“PD”), using an innovative drug administration device of Renishaw plc; and for supporting scientific research. With the grant Herantis expects its financial position to remain positive until the end of 2018 (previously estimated: End of 2017). The short name of the Horizon 2020 project is TreatER.
The TreatER project will be executed by a consortium of 11 members including Herantis as the formal sponsor of the clinical study and the owner of CNDF patents, and the University of Helsinki where CDNF was discovered. The consortium also includes three university hospitals responsible for patient treatments: Karolinska University Hospital and Lund University Hospital in Sweden, and Helsinki University Hospital in Finland; two pharmaceutical companies with strong expertise in PD: Lundbeck and Orion Pharma; Karolinska Institutet in Sweden as a leading expert in advanced PET imaging in PD; the University of Oxford and Renishaw plc in the United Kingdom; and the European Parkinson’s Disease Association.
“This is a great achievement for our consortium and a significant reward for years of hard work by the Herantis team”, says Pekka Simula, CEO of Herantis. “Horizon 2020 grants are very competitive and this award required a strong European consortium, leading science, and highest potential to advance clinical practice. Collaboration of the TreatER partners has already been unique toward a common goal: Breakthrough in the treatment of Parkinson’s disease.”
“Starting clinical studies is a great moment for a scientist. I am very optimistic about our prospects because CDNF has been efficacious in a number of disease models of Parkinson’s disease”, says professor Mart Saarma of the University of Helsinki. Professor Saarma’s scientific research lead to the discovery of CDNF and his research group continues to uncover its further potential in the treatment of neurodegenerative diseases.
The EU grant enables extending the clinical study’s CDNF treatment period to 12 months under two separate clinical protocols, and including advanced endpoints such as actigraphy and innovative PET imaging, which are expected to increase the impact of the study. The grant also provides funding for important supportive scientific research at the University of Helsinki and the University of Oxford. Herantis retains full commercial rights to CDNF.
About Parkinson’s disease
Parkinson’s disease is a slowly progressing neurodegenerative disease caused by the death of dopaminergic neurons in the midbrains. 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, 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, 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 several 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 an innovative drug development company focused on regenerative medicine and 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.
Herantis Pharma Plc
Pekka Simula, CEO,
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