lomedeucitinib (BMS-986322) / BMS - LARVOL DELTA

Bristol Myers backs out of Dupixent fight, axing allergy asset despite phase 3 win (FierceBiotech) - "Bristol Myers Squibb has continued its ruthless cost-cutting push, dropping plans to commercialize a rival to Dupixent despite meeting its phase 3 goals and pumping the brakes on a would-be Sotyktu successor...Cendakimab fell short of the bar...Last year, BMS reported a phase 3 trial in eosinophilic esophagitis met both co-primary endpoints, positioning the drugmaker to challenge Dupixent and Takeda’s Eohilia for the market...Yet, BMS quietly removed cendakimab from the pipeline in its fourth-quarter update...'Given the data that we have seen, we've made the decision not to commercialize cendakimab'....Similar thinking underpinned BMS’ decision on investing in TYK2."

Commercial • Discontinued • Eosinophilic Esophagitis • Psoriasis

A Study to Evaluate Effectiveness and Safety of BMS-986322 in Participants With Moderate-to-Severe Psoriasis (clinicaltrials.gov) - P2 | N=109 | Completed | Sponsor: Bristol-Myers Squibb | Active, not recruiting ➔ Completed

Trial completion • Dermatology • Immunology • Psoriasis

A Study to Evaluate Effectiveness and Safety of BMS-986322 in Participants With Moderate-to-Severe Psoriasis (clinicaltrials.gov) - P2 | N=120 | Active, not recruiting | Sponsor: Bristol-Myers Squibb | Recruiting ➔ Active, not recruiting

Enrollment closed • Dermatology • Immunology • Psoriasis

A Study to Evaluate the Drug Levels, Metabolism, and Removal of BMS-986322 in Healthy Adult Male Participants (clinicaltrials.gov) - P1 | N=8 | Completed | Sponsor: Bristol-Myers Squibb | Not yet recruiting ➔ Completed

Trial completion

A Study Investigating Interactions Between BMS-986322 and Rosuvastatin, Metformin and Methotrexate in Healthy Participants (clinicaltrials.gov) - P1 | N=76 | Completed | Sponsor: Bristol-Myers Squibb | Recruiting ➔ Completed

Trial completion

A Study to Evaluate Effectiveness and Safety of BMS-986322 in Participants With Moderate-to-Severe Psoriasis (clinicaltrials.gov) - P2 | N=120 | Not yet recruiting | Sponsor: Bristol-Myers Squibb

New P2 trial • Dermatology • Immunology • Psoriasis

A Study to Evaluate Effectiveness and Safety of BMS-986322 in Participants With Moderate-to-Severe Psoriasis (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: Bristol-Myers Squibb | Not yet recruiting ➔ Recruiting

Enrollment open • Dermatology • Immunology • Psoriasis

A Study to Evaluate the Drug Levels, Metabolism, and Removal of BMS-986322 in Healthy Adult Male Participants (clinicaltrials.gov) - P1 | N=8 | Not yet recruiting | Sponsor: Bristol-Myers Squibb

New P1 trial

A Study Investigating Interactions Between BMS-986322 and Rosuvastatin, Metformin and Methotrexate in Healthy Participants (clinicaltrials.gov) - P1 | N=76 | Recruiting | Sponsor: Bristol-Myers Squibb | Not yet recruiting ➔ Recruiting | N=44 ➔ 76 | Trial completion date: Jan 2023 ➔ Nov 2023 | Trial primary completion date: Jan 2023 ➔ Nov 2023

Enrollment change • Enrollment open • Trial completion date • Trial primary completion date

A Study to Investigate the Interaction of BMS-986322 and a Combined Oral Hormonal Contraceptive (Ethinyl Estradiol [EE]/Norethindrone [NET]) in Healthy Female Participants (clinicaltrials.gov) - P1 | N=42 | Completed | Sponsor: Bristol-Myers Squibb | Not yet recruiting ➔ Completed | N=30 ➔ 42

Enrollment change • Trial completion

A Study to Assess the Safety and Tolerability of BMS-986322 in Healthy Participants of Japanese Descent (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: Bristol-Myers Squibb | Recruiting ➔ Completed

Trial completion

A Study to Assess the Safety and Tolerability of BMS-986322 in Healthy Participants of Japanese Descent (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Bristol-Myers Squibb | Not yet recruiting ➔ Recruiting

Enrollment open

A Study Investigating Interactions Between BMS-986322 and Rosuvastatin or Metformin in Healthy Participants (clinicaltrials.gov) - P1 | N=44 | Not yet recruiting | Sponsor: Bristol-Myers Squibb

New P1 trial

A Study to Investigate the Interaction of BMS-986322 and a Combined Oral Hormonal Contraceptive (Ethinyl Estradiol [EE]/Norethindrone [NET]) in Healthy Female Participants (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: Bristol-Myers Squibb

New P1 trial

A Study to Assess the Safety and Tolerability of BMS-986322 in Healthy Participants of Japanese Descent (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: Bristol-Myers Squibb

New P1 trial

A Study Assessing the Drug Levels, Drug Effects, and Safety of BMS-986322 in Healthy Participants (clinicaltrials.gov) - P1 | N=171 | Completed | Sponsor: Bristol-Myers Squibb | Active, not recruiting ➔ Completed | N=432 ➔ 171 | Trial completion date: Oct 2020 ➔ Jul 2021 | Trial primary completion date: Oct 2020 ➔ Jul 2021

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

Bristol-Myers Squibb’s novel, oral, selective TYK2 inhibitor delivered significant skin clearance in patients with moderate to severe plaque psoriasis in phase 2 trial (Bristol-Myers Squibb Press Release) - P2, N=270; IM011-011 (NCT02931838); Sponsor: Bristol-Myers Squibb; "Bristol-Myers Squibb Company...today announced results from a Phase 2 study of BMS-986165...in patients with moderate to severe plaque psoriasis. Efficacy endpoints including ≥75% and 90% reduction in the Psoriasis Area and Severity Index (PASI 75, PASI 90) were achieved following 12 weeks of treatment....with a favorable risk-benefit profile. Nasopharyngitis, headache, diarrhea, nausea and upper respiratory tract infection were the most common adverse events (AEs) reported....In addition, data from the Phase 2 study describing biomarker changes and the selectivity of BMS-986165 for TYK2 in relation to clinical responses will be presented at EADV on Sept. 15, during a late-breaker session. 'Currently, patients with moderate to severe psoriasis have a limited number of oral therapies,' said Dr. Kim Papp, M.D., Ph.D..."

P2 data • Immunology • Psoriasis