Advancing Validated Drug Targets for Substance Use Disorders – US

Deadline: 18-Feb-22

The Department of Health and Human Services and National Institutes of Health has announced this Funding Opportunity Announcement (FOA) solicits grant applications from small business concerns (SBCs) to continue research projects with robustly validated targets for Substance Use Disorders (SUDs).

Objectives

• Research projects can enter either at the assay development (AD), lead identification (LI), lead optimization (LO), or preclinical development (PCD) stage.
• Projects proposing the development of therapeutics for a DSM-5 defined SUD will be considered responsive to this RFA. Projects that focus on alcohol use disorder or pain as the primary indication will not be responsive to this RFA.
• Projects failing to present the evidence supporting target validation and a TPP will also be considered nonresponsive to this RFA.
• The Principal Investigators (PIs) are strongly encouraged to assemble a team that includes expert personnel with relevant drug development/biomedical product development expertise.

Activities

Project applications submitted in response to this RFA may include, but are not limited to, the following activities:

• For the AD stage, activities consisting of the development of a primary HTS assay, chemical library selection, secondary confirmation or counter screens, criteria defined for active NCE, and performance of HTS, along with the follow-up confirmation of multiple active compounds.
• For the LI stage, activities consisting of structure-activity relationship (SAR), druggability (e.g., preliminary toxicity, Human ether-a-go-go-related gene (hERG) potassium channels, Ames), synthetic feasibility, select mechanistic assays, in vitro assessment of drug resistance and efflux potential, evidence of in vivo efficacy of chemical class, and pharmacokinetics (PK) and toxicity of chemical class known based on preliminary toxicity or in silico studies.
• For the LO stage, activities consisting of drug candidates demonstrating acceptable in vivo PK and toxicity, feasible formulation, in vivo preclinical efficacy (e.g., sufficiently powered) studies, dose range finding (DRF) pilot toxicology, process chemistry assessment of scale-up feasibility, and regulatory and marketing assessments.
• For the PCD stage, activities consisting of drug candidates demonstrating acceptable PK (with a validated bioanalytical method), absorption, distribution, metabolism, excretion (ADME) studies; demonstrating in vivo efficacy/activity, acceptable safety margin (e.g., toxicity in rodents or dogs, when appropriate), feasibility of GMP manufacture, acceptable drug interaction profile, and well-developed clinical endpoints.

Funding Information

• Award Budget: Budgets up to $320,000 total cost per project for Phase I and up to $2,500,000 total cost per project for Phase II.
• Funds Available and Anticipated Number of Awards: NIDA intends to commit $4,000,000 in FY 2022 to fund 8-12 awards in response to this FOA and the companion.
• Award Project Period: Award periods may not exceed 12 months for Phase I and 2 years for Phase II.

Eligibility Criteria

Only United States small business concerns (SBCs) are eligible to submit applications for this opportunity. A small business concern is one that, at the time of award of Phase I and Phase II, meets all of the following criteria:

• Is organized for profit, with a place of business located in the United States, which operates primarily within the United States or which makes a significant contribution to the United States economy through payment of taxes or use of American products, materials or labor;
• Is in the legal form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust or cooperative, except that where the form is a joint venture, there must be less than 50 percent participation by foreign business entities in the joint venture;
• SBIR and STTR: Be a concern which is more than 50% directly owned and controlled by one or more individuals (who are citizens or permanent resident aliens of the United States), other business concerns, an Indian tribe, ANC or NHO (or a wholly owned business entity of such tribe, ANC or NHO), or any combination of these; OR
• SBIR-only: Be a concern which is more than 50% owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these. No single venture capital operating company, hedge fund, or private equity firm may own more than 50% of the concern, unless that single venture capital operating company, hedge fund, or private equity firm qualifies as a small business concern that is more than 50% directly owned and controlled by individuals who are citizens or permanent resident aliens of the United States; OR
• SBIR and STTR: Be a joint venture in which each entity to the joint venture must meet the requirements.
• Has, including its affiliates, not more than 500 employees. If an Employee Stock Ownership Plan owns all or part of the concern, each stock trustee and plan member is considered an owner. If a trust owns all or part of the concern, each trustee and trust beneficiary is considered an owner. Definitions:
  • Hedge fund has the meaning given that term of the Bank Holding Company Act of 1956. The hedge fund must have a place of business located in the United States and be created or organized in the United States, or under the law of the United States or of any State.
  • Portfolio company means any company that is owned in whole or part by a venture capital operating company, hedge fund, or private equity firm.
  • Private equity firm has the meaning given the term “private equity fund”. The private equity firm must have a place of business located in the United States and be created or organized in the United States, or under the law of the United States or of any State.
  • Venture capital operating company means an entity. The venture capital operating company must have a place of business located in the United States and be created or organized in the United States, or under the law of the United States or of any State.
  • ANC means Alaska Native Corporation.
  • NHO means Native Hawaiian Organization.

For more information, visit https://www.grants.gov/web/grants/view-opportunity.html?oppId=334984