requests-for-proposal

Novel Drug Seeds for Non-Alcoholic Steatohepatitis

Request Number REQ5346833
Due Date September 29, 2017
Request for Proposal Details
RFP Title
Novel Drug Seeds for Non-Alcoholic Steatohepatitis
RFP Description

NineSigma, representing EA Pharma Co., Ltd. (http://www.eapharma.co.jp/en/), seeks novel drug seeds for non-alcoholic steatohepatitis (NASH).

Background

EA Pharma is the gastrointestinal specialty pharmaceutical company with a full value chain including research and development, production and logistics, sales and marketing. It was established in April 2016 after integration of Eisai's gastrointestinal disease business built up over more than 60 years and the pharmaceutical business focused on gastrointestinal disease area of the Ajinomoto Group with amino acids at its core. The integration of the product development and pipelines of Eisai Group and the Ajinomoto Group allows EA Pharma to provide a product line-up that comprehensively covers the upper and lower digestive tracts, liver and pancreas, and to offer a wide range of solutions and high level of expertise in the gastrointestinal area.

 

The targeted disease, NASH, is a medical condition with high unmet medical needs that has fatty liver as its underlying disease, and in some cases, it results in cirrhosis and hepatocellular carcinoma. Nevertheless, there has been no promising drug with both high efficacy and safety; therefore, development of a novel drug has been anticipated.

 

The client has thus issued this open request to achieve early launch of innovative NASH treatment drug by combining EA Pharma’s expertise and the new drug candidates to be proposed.

 

Anticipated Project Phases or Project Plan

Respondents should submit proposals using the attached Response Template.

 

The client will review submitted proposals and possibly ask clarifying questions before selecting the most suitable candidates for collaboration. The client will select the best candidate(s) through evaluations. During the selection process, the client may execute non-disclosure agreements (NDA) with selected respondent(s), seek further information disclosure, and discuss specific development targets or potential opportunities. The client will execute necessary agreement(s) with the selected respondent(s) and move to the advanced development phase. Specifics of any collaboration will be determined through consultation with the concerned parties.

 

Key Success Criteria

Requirements for drug seeds

The client seeks new drug candidates and pharmacological assay systems that meet the following requirements:

 

New drug candidates

  • Modality: Low molecular weight compounds, peptides, proteins, antibodies, nucleic acids, etc.
  • Anticipated efficacy:
    • Resolution of NASH
      • Suppression of degeneration (ballooning) of hepatocytes and inflammation
    • Suppression or resolution of fibrosis
  • Development level:
    • Should be from development stage to the clinical stage (phase I).
      • A candidate to be clinically developed should have been determined.
      • Or, the fibrosis-suppressing effect has been confirmed in an in vitro study and it is desirable that the efficacy has been confirmed in an in vivo study using an animal model.
      • The safety and toxicity should have been evaluated against target molecules by using siRNA, etc., or the safety and toxicity of a new drug candidate should have been evaluated.
  • The mechanism of action should be different from that of clinical development products or evidence that the candidate can be clearly differentiated from clinical development products should be presented.

 

Pharmacological assay systems

  • Should reflect the clinical condition of NASH and be in vivo, ex vivo, and in vitro assays that allow simple evaluation of the fibrosis-suppressing effect.
    • Evaluation for about 2 weeks should be possible.
    • Should have evidence that hepatic fibrosis is reflected in vivo.
    • It is desirable that verification results by using existing drug with fibrosis-suppressing effect can be presented.

 

Approaches not of interest

The following approaches are not of interest:

  • A proposal of a known substance with poor exclusivity
  • An approach to demonstrate only the anti-inflammatory effect, which leads to the suppression of fibrosis as a result
  • An approach to suppress only the hepatic cellular disorder
  • An approach to suppress only the proliferation of stellate cells
  • An approach to dissolve fibers
  • An approach to suppress only lipid metabolism abnormality

 

Preferred Collaboration types
Items to be submitted

Responses will use the Proposal Template which is linked to the “attachments“ shown at the bottom of the link <REQ5346833> and include the following items:

 

  • Type of proposed drug seed
  • Overview of the drug seed (mechanism of action, principle, superiority over common approaches, etc.)
  • Examples (pharmacology, safety, toxicity, pharmacokinetics, etc.)
  • Current research stage
  • Future research plans
  • Desired collaboration style with the client
  • Contacts and license agreements with other companies
  • Related intellectual properties
  • Organization overview and past achievements

 

Area of Interest
Request Priority
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