Herantis Pharma Plc Provides Update on Timeline for Ongoing Phase 1-2 CDNF Trial
Herantis Pharma Plc
Company release 26 September 2019 at 9:00 AM
Herantis Pharma Plc (“Herantis” or “Company”) announced today an update on the timeline for the ongoing Phase 1-2 clinical trial examining Herantis’ proprietary neuroprotective factor and novel drug candidate, CDNF, in patients with Parkinson’s disease. Patient recruitment has been completed and the medical device used in injecting CDNF has been implanted in 17 patients. The trial continues to proceed as anticipated and its first phase is expected to reach the completion of patient visits in the last quarter of 2019 in line with previously communicated timelines. The compilation and analysis of the data for the unblinding of the study may take until the first quarter of 2020. Therefore, the Company is updating guidance on the announcement of the study’s topline data from the last quarter of 2019 to the first quarter of 2020.
“Our first-in-human study with CDNF is conducted in patients with advanced Parkinson’s disease. The evaluation of safety criteria depends on a thorough analysis, and it is important that we have the time needed to prepare and interpret the results before unblinding the study,” commented Pekka Simula, CEO of Herantis. “The information on safety and tolerability will provide us with the fundamental details needed to determine the next steps for the further development of this exciting novel treatment. In addition, we look forward to the data that will keep cumulating from the ongoing extension study.”
The randomized, placebo-controlled Phase 1-2 trial is a first in human study that evaluates the safety and tolerability of CDNF, a novel experimental therapy, in a total of 17 patients with advanced Parkinson’s disease. In the main study, the patients received an implant of an investigational drug delivery system. The patients were then randomized to receive either six monthly doses of placebo, or six increasing doses of CDNF, in a blinded manner. After the main study, the patients may continue in an extension study, in which all patients receive CDNF for another six months. The extension study is followed by a long-term follow-up study.
The primary endpoints of the study will evaluate safety and tolerability of CDNF as well as dosing efficiency of the drug delivery device in the study patients. Secondary and exploratory endpoints include initial signs of efficacy, e.g. Unified Parkinson's Disease Rating Scale motor score evaluation, dopamine transporter PET imaging, and alpha synuclein level determination in CSF.
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
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. Supported by a strong preclinical proof-of-concept Herantis launched a first-in-human, randomized Phase 1-2 clinical study with CDNF in the treatment of Parkinson's disease (PD). The clinical study has received funding from the European Union's research and innovation program Horizon 2020 under the grant agreement number 732386.
CDNF administration has been safe in preclinical studies and in first clinical treatments. 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. Initial topline data of the ongoing Phase 1-2 clinical study is expected in Q1/2020.
The Phase 1-2 clinical program with CDNF comprises of three parts: Patients in the main study may continue in the extension study and follow-up study, which are already ongoing.
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 focused on regenerative medicine and unmet clinical needs. Our clinical stage assets CDNF and Lymfactin® are based on globally leading scientific research in their fields. They both aim at breakthrough in the treatment of severe diseases: CDNF in neurodegenerative diseases such as Parkinson’s disease; and Lymfactin® in 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.