BARDA Preclinical Testing Services for Botulinum Neurotoxin Therapeutics

One of the challenges faced by many early academic and small business research partners is the cost associated with demonstrating a therapeutic candidate’s effectiveness in relevant efficacy models. BARDA invites researchers to submit proposals to the Botulinum Neurotoxin (BoNT) Candidate Therapeutic Testing Service (BoNT-CTTS) to potentially include their candidate BoNT therapeutics in a preclinical evaluation. The evaluation will be performed by a BARDA contract research organization on a confidential basis at no cost to the participants.

The BoNT-CTTS supports preclinical testing of therapeutic candidates (e.g., small molecules, antibodies, and other biologics) in efficacy models of botulinum intoxication. BoNT-CTTS accepts candidate therapeutics for evaluation from academic researchers; industry, including small businesses; and other institutions. 

Candidate therapeutics selected for testing will be evaluated for efficacy against up to four BoNT serotypes in preclinical pre- and/or post-intoxication models of botulism. Specific study designs will be discussed in collaboration with the developer. Control data and product-specific data will be shared with the developer and may be published in collaboration with BARDA.

BARDA will evaluate therapeutic candidates on a rolling basis. Researchers from academic, industry, and government institutions are eligible to participate in the testing service. No financial support is available through this testing service for the participants. Selected developers will be expected to sign a material transfer agreement prior to the initiation of testing of the candidate at the contract research organization.

Those interested in participating should download and fill out the Preclinical Testing Submission Form and send an email to: 

Submissions of the Preclinical Testing Submission Form should include in vitro and in vivo efficacy data already generated against at least one BoNT serotype as well as any available safety and toxicology data. As BARDA’s requirement is to provide a product that is safe and effective against all seven major serotypes of BoNT (A-G), competitive candidates will have efficacy data generated against more than one BoNT serotype or the potential to be further developed to treat additional serotypes. Products with a demonstrated capability to address BoNT intoxication post-symptom onset and/or a mechanism of action that may neutralize intracellular toxin or reverse symptoms of intoxication are highly preferred.

Offerors should communicate any limitations on intellectual property (patents, inventions, trade secrets, copyrights, technical data, or trademarks) that might impact advanced development of the candidate product. There is no guarantee that submissions will be accepted into the testing program.