BP1.3656 / Bioprojet - LARVOL DELTA

Histamine H3 Receptor as a target for alcohol use disorder: challenging the predictability of animal models for clinical translation in drug development. (PubMed, Transl Psychiatry) - "A randomized clinical trial testing three doses of BP1.3656B versus placebo in treatment-seekers with AUD showed no reduction of heavy drinking days. Collective results illustrate the challenges inherent to clinical translation of AUD therapies, and reinforce the use of Phase IIa human laboratory paradigms as an important tool to de-risk translation of innovative drug targets for AUD."

Clinical • Journal • Preclinical • Addiction (Opioid and Alcohol)

Proof of Concept Study Evaluating BP1.3656 in Patients With Fatigue Following Ischemic Stroke (clinicaltrials.gov) - P2 | N=5 | Terminated | Sponsor: Bioprojet | N=54 ➔ 5 | Trial completion date: Jun 2024 ➔ Feb 2024 | Recruiting ➔ Terminated | Trial primary completion date: Jun 2024 ➔ Feb 2024; Lack of recruitment

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Cardiovascular • Fatigue • Ischemic stroke

Proof of Concept Study Evaluating BP1.3656 in Patients With Fatigue Following Ischemic Stroke (clinicaltrials.gov) - P2 | N=54 | Recruiting | Sponsor: Bioprojet | Trial completion date: Jun 2023 ➔ Jun 2024 | Trial primary completion date: Jun 2023 ➔ Jun 2024

Trial completion date • Trial primary completion date • Cardiovascular • Fatigue • Ischemic stroke

Role of BP1.3656 on Alcohol Responses (clinicaltrials.gov) - P2 | N=37 | Completed | Sponsor: Centre for Addiction and Mental Health | Recruiting ➔ Completed

Trial completion • Addiction (Opioid and Alcohol) • CORIN

Proof of Concept Study Evaluating BP1.3656 in Patients With Fatigue Following Ischemic Stroke (clinicaltrials.gov) - P2 | N=54 | Recruiting | Sponsor: Bioprojet | Not yet recruiting ➔ Recruiting | Trial completion date: Mar 2023 ➔ Jun 2023 | Initiation date: Mar 2022 ➔ Sep 2022 | Trial primary completion date: Mar 2023 ➔ Jun 2023

Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date • Cardiovascular • Fatigue • Ischemic stroke

Proof of Concept Study Evaluating BP1.3656 in Patients With Fatigue Following Ischemic Stroke (clinicaltrials.gov) - P2 | N=54 | Not yet recruiting | Sponsor: Bioprojet

New P2 trial • Cardiovascular • Fatigue • Ischemic stroke

Randomized Clinical Trial Evaluating BP1.3656 Versus Placebo For Alcohol Use Disorder Treatment (clinicaltrials.gov) - P2; N=210; Completed; Sponsor: Bioprojet; Recruiting ➔ Completed; N=129 ➔ 210; Trial completion date: Mar 2020 ➔ Nov 2021; Trial primary completion date: Mar 2020 ➔ Nov 2021

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Addiction (Opioid and Alcohol)

Role of BP1.3656 on Alcohol Responses (clinicaltrials.gov) - P2; N=40; Recruiting; Sponsor: Centre for Addiction and Mental Health; Not yet recruiting ➔ Recruiting; Trial completion date: Aug 2021 ➔ Aug 2022; Trial primary completion date: Aug 2021 ➔ Aug 2022

Enrollment open • Trial completion date • Trial primary completion date • Addiction (Opioid and Alcohol)

Role of BP1.3656 on Alcohol Responses (clinicaltrials.gov) - P2; N=40; Not yet recruiting; Sponsor: Centre for Addiction and Mental Health

New P2 trial

A Multisite Randomized Clinical Trial Evaluating BP1.3656 Versus Placebo For Alcohol Use Disorder Treatment (clinicaltrialsregister.eu) - P2; N=129; Ongoing; Sponsor: BIOPROJET PHARMA

New P2 trial • Addiction (Opioid and Alcohol) • Biosimilar • CNS Disorders

Randomized Clinical Trial Evaluating BP1.3656 Versus Placebo For Alcohol Use Disorder Treatment (clinicaltrials.gov) - P2; N=129; Recruiting; Sponsor: Bioprojet; Trial completion date: Jun 2019 ➔ Mar 2020; Trial primary completion date: Jun 2019 ➔ Mar 2020

Clinical • Trial completion date • Trial primary completion date