A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of Afimetoran in Participants with Active Systemic Lupus Erythematosus - NIL

Start Date16 Mar 2024

Sponsor / Collaborator

Bristol-Myers Squibb India Pvt Ltd.

NCT05866627 / RecruitingPhase 1

A Phase 1 Open-label, 2-Part Crossover Study to Assess the Effect of Acid-reducing Agent Famotidine on the Pharmacokinetics of Afimetoran (BMS-986256) in Healthy Participants

The purpose of this study is to confirm there is no significant effect of gastric pH changes of famotidine on the drug levels of afimetoran in healthy participants.

Start Date04 Jul 2023

Sponsor / Collaborator

Bristol Myers Squibb Co.

NCT05901714 / CompletedPhase 1

An Open-label, Single-sequence, Drug-drug Interaction Study in Healthy Participants to Assess the Effect of Phenytoin on the Pharmacokinetics of a Single Oral Dose of Afimetoran (BMS-986256) (Part 1) and the Effect of Steady-state Afimetoran on the Pharmacokinetics of Midazolam (Part 2)

This study will consist of 2 parts. The study will evaluate whether administration of phenytoin impacts the single-dose drug levels of afimetoran and BMT-271199 (Part 1) and will evaluate whether multiple administrations of afimetoran impact the drug levels of midazolam and 1-hydroxymidazolam (Part 2).

Start Date14 Jun 2023

Sponsor / Collaborator

Bristol Myers Squibb Co.

100 Clinical Results associated with Afimetoran

100 Translational Medicine associated with Afimetoran

100 Patents (Medical) associated with Afimetoran

Literatures (Medical) associated with Afimetoran

18 Dec 2023·Angewandte Chemie International Edition

Phenoxythiazoline (FTz)‐Cobalt(II) Precatalysts Enable C(sp²)–C(sp³) Bond‐Formation for Key Intermediates in the Synthesis of Toll‐like Receptor 7/8 Antagonists**

Article

Author: Gygi, David ; Di Mare, Francesca ; Mills, L Reginald ; Chirik, Paul J ; Simmons, Eric M ; Lee, Heejun ; Kim, Junho ; Wisniewski, Steven R

AbstractEvaluation of the relative rates of the cobalt‐catalyzed C(sp2)–C(sp3) Suzuki–Miyaura cross‐coupling between the neopentylglycol ester of 4‐fluorophenylboronic acid and N‐Boc‐4‐bromopiperidine established that smaller N‐alkyl substituents on the phenoxyimine (FI) supporting ligand accelerated the overall rate of the reaction. This trend inspired the design of optimal cobalt catalysts with phenoxyoxazoline (FOx) and phenoxythiazoline (FTz) ligands. An air‐stable cobalt(II) precatalyst, (FTz)CoBr(py)3 was synthesized and applied to the cross‐coupling of an indole‐5‐boronic ester nucleophile with a piperidine‐4‐bromide electrophile that is relevant to the synthesis of reported toll‐like receptor (TLR) 7/8 antagonist molecules including afimetoran. Addition of excess KOMe⋅B(OiPr)3 improved catalyst lifetime due to attenuation of alkoxide basicity that otherwise resulted in demetallation of the FI chelate. A first‐order dependence on the cobalt precatalyst and a saturation regime in nucleophile were observed, supporting turnover‐limiting transmetalation and the origin of the observed trends in N‐imine substitution.

100 Deals associated with Afimetoran

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Systemic Lupus Erythematosus	Phase 2	JP	Bristol Myers Squibb Co.	11 Oct 2021
Systemic Lupus Erythematosus	Phase 2	CL	Bristol Myers Squibb Co.	11 Oct 2021
Systemic Lupus Erythematosus	Phase 2	PL	Bristol Myers Squibb Co.	11 Oct 2021
Systemic Lupus Erythematosus	Phase 2	IN	Bristol Myers Squibb Co.	11 Oct 2021
Systemic Lupus Erythematosus	Phase 2	CO	Bristol Myers Squibb Co.	11 Oct 2021
Systemic Lupus Erythematosus	Phase 2	DE	Bristol Myers Squibb Co.	11 Oct 2021
Systemic Lupus Erythematosus	Phase 2	CN	Bristol Myers Squibb Co.	11 Oct 2021
Systemic Lupus Erythematosus	Phase 2	AR	Bristol Myers Squibb Co.	11 Oct 2021
Systemic Lupus Erythematosus	Phase 2	TW	Bristol Myers Squibb Co.	11 Oct 2021
Systemic Lupus Erythematosus	Phase 2	GB	Bristol Myers Squibb Co.	11 Oct 2021

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ACR2021	Not Applicable	-	-	BMS-986256 30 mg QD	sfgbztyjbt(wcytumijly) = All treatment-emergent AEs were mild and resolved spontaneously. There were no concerning abnormal laboratory test results, including tests of hepatic function and no serious AEs, deaths, or AEs leading to discontinuation. pbuvpjgces (tgzizvzkjs )	-	09 Nov 2021

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