Biomedicine

A Novel Drug, RS-D7, for the Treatment of Schizophrenia - Preclinical Safety Studies

Principal Investigator:Yufeng J. Tseng, Ph. D. 
Abstract

Schizophrenia affects 1% of the adult population worldwide. Common symptoms associated with schizophrenia include: positive, negative, cognitive, and mood-related symptoms. There are medications for positive and mood-related symptoms, yet to date, there is still no drug for the treatment of negative and cognitive symptoms. RS-D7 is a NCE discovered through "screening old drugs for new use" strategy. Other developmental advantages include:

    1. RS-D7 is orally available; it could be a first-in-class drug for treating negative symptoms.
    2. RS-D7 is safe and efficacious in preclinical animal models.
    3. RS-D7 has good clinical safety profiles. In proof of concept clinical trial, 100% patients improved both in negative and      cognitive symptoms of schizophrenia.
    4. RS-D7 is potentially effective for amnestic MCI, early AD, and MSA. 
    5. Through PCT application, U.S. patent has been granted, others in national phase.
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Team Introduction

The successful discovery and development of RS-D7 is the result of a long-term collaboration between six inventors and their research teams from: National Taiwan University, National Chiao-Tung University, and the National Health Research Institute.

The leading physician, Dr. Hai-Gwo Hwu, is the Chairman of the Mental Health Foundation and a renowned KOL in the psychiatric community. His proposal to develop DAO inhibitors combined with Prof. Jane Tseng’s use of artificial intelligence technology, led to the discovery of RS-D7. Prof. Tseng is the Global SPARK Asia Director, and the leading-PI behind preclinical designs and analyses of the novel drug compounds. Prof. Chung-Ming Sun is an expert in chemical synthesis, and Prof. Yu-Li Liu is responsible for all the high throughput screening of candidate compounds as well as in vitro validations in cell lines. Prof. Wen-Sung Lai is the Director of Neurobiology & Cognitive Science Center at NTU, responsible for in vivo validations in animal models. Dr. Chih-Min Liu leads the proof-of-concept clinical trials. This team has invested enormous effort in the development of a novel drug, to help the patients better manage their symptoms and improve their quality of life.

Figure 1. A group photo of the six inventors

Goals and Plan
Entry Barrier

Novel drug candidate RS-D7 is a metabolite of an approved drug. RS-D7 is safe and efficacious. Based on this advantage, the team has completed proof-of-concept clinical trials in different indications, and the trial outcomes have been significant so far. It is anticipated that with these pivotal data, the development of RS-D7 could be accelerated. Other competitive advantages include:

    1. RS-D7 may potentially offer multi-symptomatic relief to patients, therefore its market value is predicted to be quite substantial.
    2. Rapid patient recruitment: through Mental Health Foundation, and additional partnership with Stanford SPARK, we anticipate future recruitment for Phase I/II clinical trials can be accelerated and completed as planned.
    3. Strong product pipeline: in addition to RS-D7, the team has built up patent barrier around a series of novel compounds.
Market Scope

Schizophrenia is a debilitating mental illness that affects 1% of the adult population worldwide. There is currently no drug for the treatment of negative and cognitive symptoms. According to Decision Resources (2013), negative symptoms of schizophrenia will garner $1.5 billion in major-market sales, and the schizophrenia market will grow from $6.3 billion in 2012 to $8.0 billion in 2022. In 2012, researchers at the London School of Economics estimated that schizophrenia costs England more than US $19.7 billion each year, which is equivalent to nearly US $105,400 for each person every year, a tremendous financial burden to say the lease. To make matters worse, nearly two-thirds of the schizophrenia patients experience a combination of negative symptoms and cognitive symptoms that currently have no viable treatment option. As their negative symptoms worsen over time, the cost of care rises unnecessarily and resulting in a bigger medical and financial burden.

Figure 2. The market scope of schizophrenia

Video Introduction