5. Deucravacitinib

Bristol Myers Squibb
BMS' deucravacitinib phase 3 trials topped none other than Otezla, the Celgene psoriasis drug it divested to win regulator approval for merging.

Drug: deucravacitinib
Company: Bristol Myers Squibb
Used for: psoriasis and other inflammatory diseases
Est. 2026 sales: $2.21 billion

Bristol Myers Squibb took on some risks when it decided to keep investigational TYK2 inhibitor deucravacitinib (BMS-9861615) but divest Celgene’s growing blockbuster Otezla to win U.S. antitrust clearance for the two companies’ megamerger. But phase 3 results appeared to show that the New York pharma made the right call.

In November, Bristol Myers said deucravacitinib topped none other than Otezla in a phase 3 trial in patients with moderate to severe plaque psoriasis. More patients who got the new drug enjoyed better skin condition improvements than those Otezla takers did. Then earlier this month, it beat Otezla again in a second similar phase 3 study.

RELATED: Bristol Myers' psoriasis drug beats Amgen rival in phase 3

Back in the drug’s phase 2 trial, the percentage of patients with at least 75% reduction in skin lesions on the Psoriasis Area and Severity Index (PASI) score at week 12 reached 69% for deucravacitinib at a dosing of 3 mg twice daily. The phase 3 POETYK PSO-1 trial tested a 6 mg once-daily regimen.

Otezla, given at 30 mg twice a day, helped 31.1% and 28.8% patients achieve 75% clearer skin at week 16 in the phase 3 ESTEEM-1 and ESTEEM-2 trials, respectively, which supported its FDA go-ahead in 2014.

If those numbers play out in deucravacitinib’s phase 3 trials, it would mean some serious competition for Otezla, a PDE4 inhibitor.

Most psoriasis drugs are injectables, with oral Otezla a rare exception. That’s why the U.S. Federal Trade Commission raised the anticompetition concern of housing deucravacitinib, another oral candidate, under the same roof.

While Otezla’s oral dosing could appeal to some patients, its efficacy is widely viewed as inferior to injectable options such as AbbVie’s old stalwart Humira or newer Skyrizi. But in deucravacitinib, Bristol Myers believes it has a drug with both the oral dosing advantage and the efficacy that’s in line with the injectables.

RELATED: Amgen's Otezla faces a hit from Bristol's would-be rival, but safety data will tell the full story

Safety is also important, Cantor Fitzgerald analyst Alethia Young said in a note back in November. Bristol Myers said deucravacitinib’s phase 3 safety profile was consistent with previous phase 2 results, which Young viewed as “fairly benign.” Since Otezla boasts a fairly clean side effects list as one of its core strengthens, that safety comparison will be key, she added.

A large market awaits deucravacitinib if Otezla could be a good indication. In the first nine months of 2020, the Amgen drug hauled in $1.58 billion in sales after a 15% year-over-year growth, which was slowed by COVID-19.

Beyond psoriasis, Bristol Myers believes the TYK2 pathway could be targeted in other inflammatory diseases such as lupus, psoriatic arthritis and inflammatory bowel disease.

In terms of potential future competitors, Pfizer has a TYK2/JAK1 inhibitor called brepocitinib, which is in phase 2 development in both topical and oral formulations across a broad range of indications. But SVB Leerink analysts previously suggested that deucravacitinib’s phase 2 showing could be hard for Pfizer to beat, and the company is about two years behind Bristol Myers.

5. Deucravacitinib