Herantis Pharma elaborates on its outlook for 2016
Herantis Pharma Plc.
Company release 4 January 2016, 9:00 am
Herantis Pharma Plc ("Herantis") elaborates on its outlook regarding its clinical development and partnering plans as follows:
Cis-UCA Eye Drops
Herantis completed a randomized Phase 2 clinical study in 2015 with its cis-UCA Eye Drops in patients with Dry Eye as disclosed by a company release 3 June 2015. The study failed to meet the primary endpoints. Herantis continues discussions for a potential co-development partnership in 2016.
Herantis continues preparations of a first-in-human clinical study with CDNF in Parkinson's disease as planned. Phase 1 enabling toxicology studies have been completed and Herantis has submitted a Clinical Trial Application in December 2015. The clinical study is planned to recruit a total of 18 Parkinson's disease patients in Sweden and Finland. Herantis believes based on a decade of scientific research on CDNF that it could significantly advance the treatment of Parkinson's disease from the currently available treatments, which essentially only address the motor symptoms of the disease.
Herantis evaluates possibilities on developing CDNF in other indications such as for the treatment of Amyotrophic Lateral Sclerosis (ALS). The company has by the date of this release not made any decisions regarding possible clinical development.
As disclosed by a company release 13 November 2015 the Finnish Medicines Agency Fimea has authorized the company's first-in-man clinical study with Lymfactin® in patients with breast cancer associated lymphedema. Herantis maintains its previously disclosed target to start patient recruitment in this Phase 1 clinical study in 1H/2016. Herantis believes based on scientific research that Lymfactin® could be the first efficacious treatment for secondary lymphedema.
Herantis maintains its previous target of announcing at least one commercialization agreement related to its drug candidates by the end of 2017.
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 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 pharmaceutical company specialised in new drug research and development. The company focuses on diseases with an unmet clinical need. These diseases include for example Parkinson's disease and secondary lymphedema. The shares of Herantis are listed on the First North Finland marketplace run by Nasdaq Helsinki stock exchange.