devextinetug (IXT-m200) / InterveXion Therap - LARVOL DELTA

Comparison between a chimeric anti-methamphetamine monoclonal antibody and humanized antibodies on pharmacological effects of methamphetamine. (PubMed, Psychopharmacology (Berl)) - "The 7F9 variable region is the most promising to treat MUD."

Journal

OUTLAST: Multiple-Dose Study to Evaluate the Safety and Efficacy of IXT-m200 (clinicaltrials.gov) - P2 | N=61 | Terminated | Sponsor: InterveXion Therapeutics, LLC | N=120 ➔ 61 | Trial completion date: Dec 2024 ➔ Nov 2023 | Active, not recruiting ➔ Terminated | Trial primary completion date: Jun 2024 ➔ Sep 2023; Interim analysis concluded planned study numbers combined with participant dropout rates were insufficient to meet primary endpoint.

Enrollment change • Trial completion date • Trial primary completion date • Trial termination

Meth-OD: A Study of IXT-m200 in Patients With Toxicity From Methamphetamine Overdose (clinicaltrials.gov) - P2 | N=20 | Terminated | Sponsor: InterveXion Therapeutics, LLC | Phase classification: P2a ➔ P2

Phase classification

OUTLAST: Multiple-Dose Study to Evaluate the Safety and Efficacy of IXT-m200 (clinicaltrials.gov) - P2 | N=120 | Active, not recruiting | Sponsor: InterveXion Therapeutics, LLC | Recruiting ➔ Active, not recruiting

Enrollment closed

Meth-OD: A Study of IXT-m200 in Patients With Toxicity From Methamphetamine Overdose (clinicaltrials.gov) - P2a | N=20 | Terminated | Sponsor: InterveXion Therapeutics, LLC | N=40 ➔ 20 | Recruiting ➔ Terminated; Sponsor decision based on slower than anticipated enrollment leading to fund exhaustion.

Enrollment change • Trial termination

Meth-OD: A Study of IXT-m200 in Patients With Toxicity From Methamphetamine Overdose (clinicaltrials.gov) - P2a | N=40 | Recruiting | Sponsor: InterveXion Therapeutics, LLC | Trial completion date: Sep 2022 ➔ Dec 2022 | Trial primary completion date: Aug 2022 ➔ Dec 2022

Trial completion date • Trial primary completion date

OUTLAST: Multiple-Dose Study to Evaluate the Safety and Efficacy of IXT-m200 (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: InterveXion Therapeutics, LLC | Trial completion date: Dec 2023 ➔ Dec 2024 | Trial primary completion date: Oct 2023 ➔ Jun 2024

Trial completion date • Trial primary completion date

New Results From Phase 2 Trials of IXT-M200, a High Affinity METH Antibody (CPDD 2022) - No abstract available

P2 data

STAMPOUT: Impact in Humans of IXT-M200 (a High-Affinity Methamphetamine Antibody) on Methamphetamine Concentrations and Effects (CPDD 2022) - "IXT-m200 successfully achieved the primary endpoint in STAMPOUT, alteration in METH PK (p<0.001). IXT-m200 was well-tolerated in METH users given METH challenges following a single IXT-m200 dose, and demonstrated an acceptable safety profile supportive of further development."

OUTLAST: Multiple-Dose Study to Evaluate the Safety and Efficacy of IXT-m200 (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: InterveXion Therapeutics, LLC | Not yet recruiting ➔ Recruiting

Enrollment open

Safety, Tolerability, and Pharmacokinetics of IXT-m200 (clinicaltrials.gov) - P1 | N=9 | Completed | Sponsor: InterveXion Therapeutics, LLC | Active, not recruiting ➔ Completed

Trial completion

STAMPOUT: Study of Antibody for Methamphetamine Outpatient Therapy (clinicaltrials.gov) - P1/2 | N=77 | Completed | Sponsor: InterveXion Therapeutics, LLC | N=56 ➔ 77

Enrollment change

Safety, Tolerability, and Pharmacokinetics of IXT-m200 (clinicaltrials.gov) - P1; N=9; Active, not recruiting; Sponsor: InterveXion Therapeutics, LLC; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed

Safety, Tolerability, and Pharmacokinetics of IXT-m200 (clinicaltrials.gov) - P1; N=9; Recruiting; Sponsor: InterveXion Therapeutics, LLC; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

OUTLAST: A Phase 2 Multiple-Dose Study to Evaluate the Safety and Efficacy of IXT-m200 (clinicaltrials.gov) - P2; N=120; Not yet recruiting; Sponsor: InterveXion Therapeutics, LLC

Clinical • New P2 trial

Phase 1 Safety, Tolerability, and Pharmacokinetics of IXT-m200 in Healthy Volunteers (clinicaltrials.gov) - P1; N=9; Not yet recruiting; Sponsor: InterveXion Therapeutics, LLC

Clinical • New P1 trial