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2021-02-03| Trials & Approvals

Bristol Myers Squibb Registers Another Trial Win for its Psoriasis Med

by Ruchi Jhonsa
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When Bristol Myers acquired Celgene in 2019, it was forced to give up one of its psoriasis meds as regulators were concerned about BMS potentially cornering the entire market. The drug was picked up by Amgen who saw enormous potential in it, paying Celgene a whopping $13.4 billion. Certainly, Amgen’s predictions came true, which pulled in roughly $1.04 billion through the sales of Otezla in the first half of last year. This was deucravacitinib big blow for BMS at the time; however, today it is ready with its own psoriasis drug, which can give Amgen a tough fight.

In a head-to-head second Phase 3 study, BMS announced today that its oral psoriasis drug, deucravacitinb outperformed Amgen’s Otezla in patients with moderate to severe psoriasis. The 1020 patient study, POETYK PSO-2 reported that deucravacitinib was found to be superior to both placebo and Otelza on the two scores, known as PASI and sPGA, commonly used scores for measuring psoriasis severity. After 16 weeks of treatment with a 6mg dose of the drug, “significantly more patients” were found to have a 75% reduction of psoriasis area and severity and clear or almost clear skin as compared to the placebo.

Additionally, the drug beat Amgen’s Otzela, an FDA-approved drug for psoriasis on these measures, striking key secondary endpoints and did not result in any serious side effects. These results are consistent with the data reported from the first Phase 3 trial in November last year.

 

Deucravacitib’s Unique Mechanism of Action

Deucravacitib is a kinase inhibitor that blocks a kinase called TYK2, a protein that relays signals to proteins involved in inflammatory and immune responses. These pathways are implicated in the pathogenesis of psoriasis and other immune-mediated diseases. While there are multiple drugs in the market for this indication, what makes this one unique is its ability to target multiple inflammatory pathways together.

Samit Hirawat, executive vice president, chief medical officer, global drug development, Bristol Myers Squibb opines, “The superior efficacy we have observed in patients with moderate to severe psoriasis, combined with the well-tolerated safety profile, are consistent with the novel mechanism of action of deucravacitinib, a potential new class of molecule.”

 

Deucravacitib’s Distinctive Advantage

The psoriasis market held a market share of $16.21 billion in the year 2018, which is expected to grow at a rate of 9.6% to reach 39 billion by 2027. While many drugs are congesting this market at the moment, deucravacitinib has a distinctive advantage that will quickly make it a favorite with patients and physicians and reap BMS heavy profits. Unlike other psoriasis drugs, which are mostly injectables, BMS’s psoriasis med is an oral drug. Topping that, the drug has achieved the same level of effectiveness as the other injectables such as Humira in treating psoriasis. An oral drug with similar effectiveness as injectables could be quickly adopted.

Moreover, the drug’s remarkable safety profile could eventually help it take over JAK inhibitors, which have been scrutinized for potentially worrisome side effects.

According to Dr. Bruce Strober, M.D., Ph.D., Clinical Professor of dermatology at Yale University School of Medicine and Central Connecticut Dermatology, “This represents an important step for the over 100 million people living with psoriasis worldwide, many of whom remain undertreated and are in need of new, effective oral therapies.”

BMS is not going to stop at just one psoriasis med. It is already is working on a second TYK2 inhibitor and holds an exclusive license option to license or acquire a TYK2 inhibitor from Nimbus Therapeutics-a deal that the company acquired during the Celgene merger. The drug from Nimbus will enter Phase 2 testing this year. This will give BMS plenty of options to cash on in the future and reduce its dependency on one drug.

Related Article: Bristol Myers Squibb’s Deucravacitinib Impresses in Phase 3 Psoriasis Trial

References

  1. https://news.bms.com/news/corporate-financial/2021/Bristol-Myers-Squibb-Announces-Positive-Topline-Results-from-Second-Pivotal-Phase-3-Psoriasis-Study-Showing-Superiority-of-Deucravacitinib-Compared-to-Placebo-and-Otezla-apremilast/default.aspx
  2. https://www.globenewswire.com/news-release/2020/01/22/1973657/0/en/Psoriasis-Drugs-Market-To-Reach-USD-39-00-Billion-By-2027-Reports-And-Data.html#:~:text=The%20growth%20rate%20witnessed%20by%20the%20segment%20is%20resultant%20of,9.7%25%20during%20the%20forecast%20period

 

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