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STAMPOUT: A Phase 2a Study of Antibody for Methamphetamine Outpatient Therapy

Award Number: U01DA045366
ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/30/2017
PERIOD OF PERFORMANCE END DATE: 07/31/2022

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STAMPOUT: A Phase 2a Study of Antibody for Methamphetamine Outpatient Therapy - The US FDA has not approved any medications for the treatment of methamphetamine (METH) use disorders. Currently, cognitive-behavioral and contingency-management interventions are the most effective treatments. IXT-m200, a monoclonal antibody that specifically binds METH in the blood, is being developed as a pharmacological treatment for use in conjunction with behavior therapies. Based on nonclinical studies, IXT-m200 is expected to alter METH pharmacokinetics in human subjects resulting in reduced or blocked METH subjective effects that reinforce METH use. STAMPOUT, a Phase 2a Study of Antibody for Methamphetamine Outpatient Therapy, will provide proof-of-concept that IXT-m200 can alter METH disposition. This is needed before a large efficacy study can be done. This application proposes the first clinical study in METH users of a biological medication developed specifically for patients with METH use disorders. The primary goal of this application is to show that a METH antibody will alter the pharmacokinetics of METH in users and reduce the reinforcing subjective effects that perpetuate METH use. During the STAMPOUT study, METH-using subjects will receive single doses of IXT-m200 followed by weekly METH challenges. Serial blood samples and urine collections will be analyzed to determine the METH pharmacokinetic changes due to the antibody dose. Drug effects questionnaires given after METH challenges will quantify the impact of IXT-m200 on the subjective effects of METH. These data will be used to determine the minimum serum concentration of IXT-m200 necessary for reducing reinforcing subjective effects of METH. Also during this project, there will be interaction with the FDA and the overall clinical development plan will be advanced by planning for a Phase 2b/3 clinical study in larger groups of users who wish to quit using METH. Stability testing of the IXT-m200 drug product will continue throughout the study, along with additional manufacturing work as necessary to support the STAMPOUT study. A highly experienced, transdisciplinary academic and industry team will accomplish the following Specific Aims: 1) Advance the clinical development of IXT-m200 by interacting with FDA and planning for future studies, 2) Complete STAMPOUT, a Phase 2a Study of Antibody for Methamphetamine Outpatient Therapy, and 3) Perform manufacturing tasks required to support a clinical study of IXT-m200. STAMPOUT is a turning point. With proof-of-concept data, plans can be made to study long-term efficacy of IXT-m200 in helping METH users quit and move this game changing medication toward the market and the patients who need it.


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: 2023 ( Subtotal = -$155,717 )
2023	2019	INTERVEXION THERAPEUTICS, LLC.	401 S CEDAR ST	LITTLE ROCK	AR	72205	PULASKI	USA	Drug Use and Addiction Research Programs	000	3	8/28/2023	NON-COMPETING CONTINUATION	-$155,717
														Subtotal = -$155,717

Issue Date FY: 2021 ( Subtotal = $0 )
2021	2019	INTERVEXION THERAPEUTICS, LLC.	401 S CEDAR ST	LITTLE ROCK	AR	72205	PULASKI	USA	Drug Use and Addiction Research Programs	001	3	9/29/2021	NON-COMPETING CONTINUATION	$0
2021	2019	INTERVEXION THERAPEUTICS, LLC.	401 S CEDAR ST	LITTLE ROCK	AR	72205	PULASKI	USA	Drug Use and Addiction Research Programs	000	3	7/13/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $0 )
2020	2019	INTERVEXION THERAPEUTICS, LLC.	4301 W MARKHAM #831	LITTLE ROCK	AR	72205	PULASKI	USA	Drug Use and Addiction Research Programs	001	3	2/20/2020	NON-COMPETING CONTINUATION	$0
2020	2019	INTERVEXION THERAPEUTICS, LLC.	4301 W MARKHAM #831	LITTLE ROCK	AR	72205	PULASKI	USA	Drug Use and Addiction Research Programs	000	3	10/29/2019	SUPPLEMENT FOR EXPANSION	$0
														Subtotal = $0

Issue Date FY: 2019 ( Subtotal = $2,368,200 )
2019	2019	INTERVEXION THERAPEUTICS, LLC.	4301 W MARKHAM #831	LITTLE ROCK	AR	72205	PULASKI	USA	Drug Use and Addiction Research Programs	001	3	9/6/2019	SUPPLEMENT FOR EXPANSION	$1,429,307
2019	2019	INTERVEXION THERAPEUTICS, LLC.	4301 W MARKHAM #831	LITTLE ROCK	AR	72205	PULASKI	USA	Drug Use and Addiction Research Programs	002	3	9/17/2019	SUPPLEMENT FOR EXPANSION	$0
2019	2019	INTERVEXION THERAPEUTICS, LLC.	4301 W MARKHAM #831	LITTLE ROCK	AR	72205	PULASKI	USA	Drug Use and Addiction Research Programs	000	3	7/23/2019	NON-COMPETING CONTINUATION	$938,893
														Subtotal = $2,368,200

Issue Date FY: 2018 ( Subtotal = $2,735,856 )
2018	2018	INTERVEXION THERAPEUTICS, LLC.	4301 W MARKHAM #831	LITTLE ROCK	AR	72205	PULASKI	USA	Drug Use and Addiction Research Programs	000	2	8/10/2018	NON-COMPETING CONTINUATION	$2,735,856
														Subtotal = $2,735,856

Issue Date FY: 2017 ( Subtotal = $4,601,742 )
2017	2017	INTERVEXION THERAPEUTICS, LLC.	4301 W MARKHAM #831	LITTLE ROCK	AR	72205	PULASKI	USA	Drug Use and Addiction Research Programs	000	1	9/26/2017	NEW	$4,493,715
2017	2017	INTERVEXION THERAPEUTICS, LLC.	4301 W MARKHAM #831	LITTLE ROCK	AR	72205	PULASKI	USA	Drug Use and Addiction Research Programs	001	1	9/28/2017	NEW	$108,027
														Subtotal = $4,601,742

Grand Total All Awards = $9,550,081

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STAMPOUT: A Phase 2a Study of Antibody for Methamphetamine Outpatient Therapy

Award Number: U01DA045366

ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 09/30/2017

PERIOD OF PERFORMANCE END DATE: 07/31/2022

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