Herantis Pharma Plc completes patient treatments in main study of Phase 1-2 CDNF trial in Parkinson’s disease
Herantis Pharma Plc
Company release, insider information 19 Dec 2019 at 4:00 PM Eastern European Time
Herantis Pharma Plc (“Herantis” or “Company”) announced today having completed patient treatments as planned in the main study of the Company’s Phase 1-2 clinical trial examining Herantis’ proprietary neuroprotective factor and novel drug candidate CDNF in patients with Parkinson’s disease. Of the 17 patients randomized in the clinical trial, 15 patients completed the main study according to the study protocol and two patients discontinued due to reasons not related to CDNF. All 15 patients who completed the main study have decided to continue in the six-month extension protocol with continued monthly CDNF dosing.
“We are very grateful to the patients, the investigators, and the hospital staff of this clinical study,” commented Pekka Simula, CEO of Herantis. “We look forward to the excellently continuing collaboration in the ongoing extension study, as well as to the near-future read-outs from the main study.”
Herantis expects to announce initial data from the main study in the first quarter of 2020.
Study Design
The randomized, blinded, placebo-controlled Phase 1-2 trial is a first in human clinical trial that evaluates the safety and tolerability of CDNF, a novel experimental therapy, in patients with advanced Parkinson’s disease. In the main study, the patients received an implanted investigational drug delivery system and were randomized to receive either six monthly doses of placebo, or six increasing doses of CDNF. All patients who completed the main study decided to continue in the extension study, in which all patients are randomized to receive either higher or lower monthly CDNF doses for another six months. The extension study, which is expected to be completed latest in Q3/2020, is followed by a long-term follow-up study.
Study Objectives
The primary endpoints of the study will evaluate the safety and tolerability of CDNF as well as of the drug delivery device, and accuracy of surgical placement of the device in the study patients. The secondary and exploratory endpoints include initial signs of efficacy of CDNF treatment, e.g. Unified Parkinson's Disease Rating Scale motor score evaluation, patient diary, dopamine transporter PET imaging, and the levels of different forms of alpha-synuclein in serum and cerebrospinal fluid.
Further information:
Herantis Pharma Plc, Pekka Simula, CEO, telephone: +358 40 7300 445
Company web site: www.herantis.com
Certified Advisor: UB Securities Ltd, Finland: +358 9 25 380 225, Sweden: +46 72 888 43 83
About CDNF
CDNF is a novel neuroprotective and neurorestorative factor highly distinct from conventional neurotrophic factors. An innovative drug candidate for the treatment of neurodegenerative diseases, CDNF is patented internationally by Herantis. CDNF has been safe in preclinical studies. In disease models, CDNF has protected and regenerated dopamine-generating cells in the midbrain suggesting potential for disease modification of PD. It has also shown efficacy in non-motor symptoms of PD.
CDNF is currently in a Phase 1-2 clinical trial in Parkinson’s disease with initial data expected in Q1/2020. The clinical trial has received funding from the European Union's research and innovation program Horizon 2020 under the grant agreement number 732386.
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 symptoms of the disease include tremors, rigidity, and slowness of movement. While the motor symptoms can be treated with medication the progression of the disease cannot be prevented. The benefits of medication may be lost with disease progression or their side effects can become unmanageable. The progressing disease is also associated with non-motor symptoms such as sleep problems, depression, and anxiety, which are not alleviated by current Parkinson's drugs. It is estimated that 7-10 million people worldwide suffer from Parkinson's disease.
About Herantis Pharma Plc
Herantis Pharma Plc is an innovative drug development company breaking the boundaries of standard therapeutic approaches. Our regenerative medicine drug candidates, CDNF and Lymfactin®, aim to revolutionize the treatment of Parkinson’s disease and other neurodegenerative diseases, and of secondary lymphedema. The shares of Herantis are listed on the Nasdaq First North Growth Market Finland with ticker symbol “HRTIS” and on the Nasdaq First North Growth Market Sweden with ticker symbol “HRNTS”.