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Pfizer (PFE) Reports More Positive Data From Etrasimod Study
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Pfizer (PFE - Free Report) presented detailed data from two pivotal studies on its pipeline candidate, etrasimod, which demonstrated the candidate’s clear benefit for the treatment of moderately to severely active ulcerative colitis (UC). The data were presented at the Digestive Disease Week conference.
Earlier this year Pfizer had already said that the two pivotal studies, ELEVATE UC 52 and ELEVATE 12, on etrasimod, a once-daily, oral, selective sphingosine 1-phosphate (S1P) receptor modulator, met the primary endpoint of clinical remission and all key secondary endpoints. It did not provide detailed data at that time.
The detailed data showed that in the 52-week ELEVATE UC 52 study, clinical remission was achieved in 27.0% of patients given etrasimod compared to 7.4% for patients receiving placebo at week 12. However, at week 52, clinical remission was 32.1% in the etrasimod arm compared to 6.7% in the placebo arm. Similarly in the 12-week ELEVATE UC 12 study, clinical remission was achieved among 24.8% of patients in the etrasimod arm compared to 15.2% in the placebo arm.
Pfizer’s stock is down 9.5% this year so far against an increase of 5.1% for the industry.
Image Source: Zacks Investment Research
The ELEVATE UC 52 study demonstrated statistically significant improvements in all key secondary endpoints including endoscopic improvement, symptomatic remission, and mucosal healing at weeks 12 and 52, and corticosteroid-free remission and sustained clinical remission at week 52. The key secondary endpoints of endoscopic improvement, symptomatic remission, and mucosal healing were also met in the ELEVATE UC 12 study.
Data from ELEVATE 12 and ELEVATE 52 studies will form the basis of the regulatory submissions on etrasimod, which are expected later this year.
If approved by the FDA, etrasimod will face competition from Bristol-Myers’s (BMY - Free Report) new S1P receptor modulator, Zeposia, which was approved as an oral medicine for treating moderately to severely active UC last year. Zeposia is also approved for the treatment of adults with relapsing forms of multiple sclerosis.
S1P receptor modulators like etrasimod and Bristol-Myers’ Zeposia represent a different mechanism of action than available UC therapies and represent a new treatment option that can provide symptom relief and remission to patients.
Etrasimod was added to Pfizer’s inflammation and immunology pipeline with the March 2022 $6.7 billion acquisition of Arena Pharmaceuticals. Apart from UC, etrasimod is being studied across multiple gastroenterology and dermatology indications, including atopic dermatitis, eosinophilic esophagitis, Crohn’s disease and alopecia areata.
The Zacks Consensus Estimate for Alkermes’ 2022 loss per share has narrowed from 10 cents to 3 cents in the past 30 days. Shares of ALKS have risen 21.9% year to date.
Earnings of Alkermes beat estimates in each of the last four quarters, the average being 350.5%.
The Zacks Consensus Estimate for Sesen Bio’s 2022 loss has declined from 33 cents to 32 cents per share in the past 30 days. Shares of SESN have declined 36.1% in the year-to-date period.
Earnings of Sesen Bio beat estimates in three of the last four quarters and missed the mark on one occasion, the average surprise being 69.9%.
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Pfizer (PFE) Reports More Positive Data From Etrasimod Study
Pfizer (PFE - Free Report) presented detailed data from two pivotal studies on its pipeline candidate, etrasimod, which demonstrated the candidate’s clear benefit for the treatment of moderately to severely active ulcerative colitis (UC). The data were presented at the Digestive Disease Week conference.
Earlier this year Pfizer had already said that the two pivotal studies, ELEVATE UC 52 and ELEVATE 12, on etrasimod, a once-daily, oral, selective sphingosine 1-phosphate (S1P) receptor modulator, met the primary endpoint of clinical remission and all key secondary endpoints. It did not provide detailed data at that time.
The detailed data showed that in the 52-week ELEVATE UC 52 study, clinical remission was achieved in 27.0% of patients given etrasimod compared to 7.4% for patients receiving placebo at week 12. However, at week 52, clinical remission was 32.1% in the etrasimod arm compared to 6.7% in the placebo arm. Similarly in the 12-week ELEVATE UC 12 study, clinical remission was achieved among 24.8% of patients in the etrasimod arm compared to 15.2% in the placebo arm.
Pfizer’s stock is down 9.5% this year so far against an increase of 5.1% for the industry.
Image Source: Zacks Investment Research
The ELEVATE UC 52 study demonstrated statistically significant improvements in all key secondary endpoints including endoscopic improvement, symptomatic remission, and mucosal healing at weeks 12 and 52, and corticosteroid-free remission and sustained clinical remission at week 52. The key secondary endpoints of endoscopic improvement, symptomatic remission, and mucosal healing were also met in the ELEVATE UC 12 study.
Data from ELEVATE 12 and ELEVATE 52 studies will form the basis of the regulatory submissions on etrasimod, which are expected later this year.
If approved by the FDA, etrasimod will face competition from Bristol-Myers’s (BMY - Free Report) new S1P receptor modulator, Zeposia, which was approved as an oral medicine for treating moderately to severely active UC last year. Zeposia is also approved for the treatment of adults with relapsing forms of multiple sclerosis.
S1P receptor modulators like etrasimod and Bristol-Myers’ Zeposia represent a different mechanism of action than available UC therapies and represent a new treatment option that can provide symptom relief and remission to patients.
Etrasimod was added to Pfizer’s inflammation and immunology pipeline with the March 2022
$6.7 billion acquisition of Arena Pharmaceuticals. Apart from UC, etrasimod is being studied across multiple gastroenterology and dermatology indications, including atopic dermatitis, eosinophilic esophagitis, Crohn’s disease and alopecia areata.
Pfizer currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Stocks to Consider
Some better-ranked biotech stocks are Alkermes (ALKS - Free Report) and Sesen Bio . While Sesen has a Zacks Rank #1, Alkermes has a Zacks Rank of 2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
The Zacks Consensus Estimate for Alkermes’ 2022 loss per share has narrowed from 10 cents to 3 cents in the past 30 days. Shares of ALKS have risen 21.9% year to date.
Earnings of Alkermes beat estimates in each of the last four quarters, the average being 350.5%.
The Zacks Consensus Estimate for Sesen Bio’s 2022 loss has declined from 33 cents to 32 cents per share in the past 30 days. Shares of SESN have declined 36.1% in the year-to-date period.
Earnings of Sesen Bio beat estimates in three of the last four quarters and missed the mark on one occasion, the average surprise being 69.9%.