With a potential Bristol Myers rival looming on the horizon, Amgen's inflammatory disease med Otezla is hustling to cement its position in psoriasis. Now, the drug has notched a win in a trial for a highly stigmatized disease that can affect more than half of psoriasis patients.
Otezla trumped placebo in adults with moderate to severe genital psoriasis and moderate to severe plaque psoriasis, top-line results from Amgen's phase 3 Discreet study show. The PDE4 inhibitor also met its secondary endpoints, charting “meaningful and significant” improvements on measures of itchiness, quality of life and more.
The data put Otezla in the running for another psoriasis nod—and the drug could certainly use the boost. Otezla, which Amgen bought from Celgene in 2019 for $13.4 billion, may soon face pressure from Bristol Myers Squibb’s TYK2 inhibitor deucravacitinib. BMS expects to launch its rival in the second half of 2022.
Meanwhile, Otezla is awaiting a December FDA decision to move into milder plaque psoriasis, which would open the door to an additional 1.5 million patients. The drug is currently approved in moderate to severe plaque psoriasis, plus psoriatic arthritis and Behcet's disease.
Genital psoriasis is a highly stigmatizing disease that can affect up to 63% of psoriasis patients, David Reese, M.D., executive vice president of research and development at Amgen, said in a release. Treatment often comes in the form of topical therapies, but many patients still find it tough to manage their condition, which has prompted experts to call for systemic treatments, he said.
About 125 million people worldwide, or 2% to 3% of the total population, have psoriasis, the National Psoriasis Foundation says. That means there could be around 75 million people worldwide suffering from genital psoriasis.
Amgen’s Discreet study used the modified static Physician’s Global Assessment of Genitalia (sPGA-G)—which tracks the severity of genital psoriasis—for its primary endpoint. Success was defined as an sPGA-G response score of 0, meaning clear, or 1, meaning almost clear, with at least a 2-point reduction from baseline at week 16.
Patients who received 30 mg Otezla twice a day hit clinically meaningful and statistically significant improvements over placebo on their sPGA-G responses, Amgen said. The drug also met all its secondary endpoints, leading to “meaningful and significant” improvements on measures of genital psoriasis itch, affected body surface area, quality of life and more.
The Discreet phase 3 looked at Otezla or placebo in 289 patients. Patients were randomized to receive either twice-daily Otezla or a dummy drug for the first 16 weeks of the study. After that portion of the study wrapped, patients either continued or switched to Otezla for treatment through week 32.
The study is ongoing and expected to conclude in the first half of 2022, Amgen said. The California-based drugmaker plans to present its 16-week results at an upcoming medical conference.
He forecasted $2 billion in 2025 sales for the drug, well below consensus estimates of around $3 billion. The main threat could come from deucravacitinib, which recently topped Otezla at clearing skin in moderate to severe plaque psoriasis patients.