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First-in-Human Clinical Development of a Novel Drug Candidate with a First-in-Class Mechanism for Smoking Cessation and Abstinence

Award Number: U01DA054882
ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

Group Awards By Issue Date FY or Funding FY:

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ABSTRACT The Administrative Supplement requests support for costs arising from unanticipated expenses to conduct preclinical studies required by the FDA and to be able to continue our Phase 1 single-ascending dose clinical trial of the novel smoking cessation pharmacotherapy on our current active U01 grant U01DA054882. The required preclinical studies were not expected and thus not planned for but are now necessary to preserve the overall impact of the project consistent with its originally approved Specific Aims and overall objectives. Our current grant aims to advance the clinical development of a novel smoking cessation pharmacotherapy into first-in-human (FIH) Phase 1 and early Phase 2A efficacy clinical trials, subsequent to obtaining FDA approval of the IND for these clinical trials. This novel small-molecule drug candidate is a new chemical entity with a first-in-class pharmacological mechanism targeting the a3ß4 nicotinic acetylcholine receptor (nAChR) subtype. The objectives of our currently funded grant U01DA054882 are to conduct a Phase 1 single- and multiple-ascending dose (SAD/MAD) FIH trial to assess the safety, tolerability and pharmacokinetic (PK) profile in humans, and to conduct an efficient Early Phase 2 trial using a crossover procedure that will provide an early readout of medication efficacy for smoking cessation and a Go/No-go decision to advance this novel first-in-class candidate to subsequent larger randomized Phase 2 trials. As required by the FDA, our experienced drug development team has designed preclinical studies in rat to address the FDA questions and obtained FDA feedback on the proposed studies to be conducted. The Administrative supplement requests additional funding for these unanticipated studies, which will allow us to continue our clinical trial and meet the overall objectives of our grant.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2024 ( Subtotal = $99,995 )
2024	2024	ASTRAEA THERAPEUTICS LLC	320 LOGUE AVE STE 142	MOUNTAIN VIEW	CA	94043	SANTA CLARA	USA	Drug Abuse and Addiction Research Programs	000	3	4/12/2024	SUPPLEMENT FOR EXPANSION	$99,995
														Subtotal = $99,995

Issue Date FY: 2023 ( Subtotal = $1,398,808 )
2023	2023	ASTRAEA THERAPEUTICS LLC	20170 SEA GULL WAY	SARATOGA	CA	95070	SANTA CLARA	USA	Drug Abuse and Addiction Research Programs	000	3	4/28/2023	NON-COMPETING CONTINUATION	$1,398,808
														Subtotal = $1,398,808

Issue Date FY: 2022 ( Subtotal = $2,107,278 )
2022	2022	ASTRAEA THERAPEUTICS LLC	20170 SEA GULL WAY	SARATOGA	CA	95070	SANTA CLARA	USA	Drug Abuse and Addiction Research Programs	003	2	5/10/2022	NON-COMPETING CONTINUATION	$2,107,278
2022	2021	ASTRAEA THERAPEUTICS LLC	20170 SEA GULL WAY	SARATOGA	CA	95070	SANTA CLARA	USA	Drug Abuse and Addiction Research Programs	001	1	5/4/2022	NEW	$0
2022	2021	ASTRAEA THERAPEUTICS LLC	20170 SEA GULL WAY	SARATOGA	CA	95070	SANTA CLARA	USA	Drug Abuse and Addiction Research Programs	002	1	5/9/2022	NEW	$0
2022	2021	ASTRAEA THERAPEUTICS LLC	20170 SEA GULL WAY	SARATOGA	CA	95070	SANTA CLARA	USA	Drug Abuse and Addiction Research Programs	000	1	11/12/2021	NEW	$0
														Subtotal = $2,107,278

Issue Date FY: 2021 ( Subtotal = $2,007,282 )
2021	2021	ASTRAEA THERAPEUTICS LLC	20170 SEA GULL WAY	SARATOGA	CA	95070	SANTA CLARA	USA	Drug Abuse and Addiction Research Programs	000	1	7/16/2021	NEW	$2,007,282
														Subtotal = $2,007,282

Grand Total All Awards = $5,613,363

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First-in-Human Clinical Development of a Novel Drug Candidate with a First-in-Class Mechanism for Smoking Cessation and Abstinence

Award Number: U01DA054882

ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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