New Anti-fibrosis Drug with Molecular Targeting DDS Completed Phase-1a Dose Escalation

Nitto Denko Corporation (Nitto) has been developing a new RNAi based drug for treating fibrosis in liver and other organs since 2008 in collaboration with Prof.Yoshiro Niitsu of Sapporo Medical University. In June 2013, Nitto initiated a phase-1 clinical study in the US, and it is happy to announce that dosing in healthy volunteers has been completed. Currently, Nitto is advancing the drug to phase-1/2 clinical study in patients for the assessment of safety and efficacy.

Nitto's new anti-fibrotic therapy consists of siRNA which specifically inhibits the cause of fibrosis as well as a targeted lipid nanoparticle delivery system which can deliver the siRNA to the cells responsible for fibrosis. Therefore, the new drug has a dual targeting mechanism in both drug delivery and action. Furthermore, this anti-fibrosis therapy can be a revolutionary drug which leads complete resolution of liver fibrosis and other organ fibrosis, which is not available so far. Nitto also obtained relevant granted intellectual properties of therapeutic modality in Japan, US, Europe, China, Canada, Australia and Korea, as well as drug formulations including siRNA and DDS.

Nitto is also pursuing research activities in tissue regeneration mechanisms related to our therapeutic modality, in addition to new oncology programs which were derived from fibrosis drug development. Those research activities are carried out with collaborations and supports from Sapporo Medical University and Hokkaido University and others.

Nitto plans to initiate phase-1/2 clinical study in US this year in order to assess safety and efficacy in patients, and expects to collaborate with pharmaceutical company from late phase-2 stage toward approval from the agency in 2018 or after. Nitto continues to put all efforts to deliver new drugs for fibrosis and other intractable diseases to patients in need.

* Molecular Targeting DDS: A Drug Delivery System which targets to specific molecule, which enables to deliver desired amount of drug to only preferable site(s) to be delivered.
* Phase-1 clinical study: Assessment of drug safety in human
* Phase-2 clinical study: Assessment of drug efficacy in human

Nitto produces various products across a broad range of industries through a combination of technologies based on polymer synthesis, such as industrial tapes and electronics-related materials (e.g. optical films for LCDs.) In the medical field, Nitto has also been developing businesses related to transdermal drug delivery patches and nucleic acid synthesis. Nitto will capitalize on its experience in these areas to develop therapeutic agents in the future. Nitto will continue to create new value and businesses in the "Green (environmental), Clean (new energy) and Fine (life sciences)" business domains.