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Lilly (LLY) Phase III Study in Ulcerative Colitis Meets Goal
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Eli Lilly (LLY - Free Report) announced positive data from the phase III maintenance study, LUCENT-2, evaluating its IL-23 inhibitor, mirikizumab, for the treatment of patients with moderately-to-severely active ulcerative colitis (UC).
The LUCENT-2 study enrolled patients who completed the phase III induction study, LUCENT-1, which evaluated patients receiving mirikizumab over a period of 12 weeks. The LUCENT-2 achieved the primary endpoint of clinical remission by controlling/resolving the inflammation of the colon at one year compared to placebo.
LUCENT-2 also achieved all key secondary endpoints with statistical significance over placebo at year one in terms of achieving a reduction of bowel urgency, endoscopic remission, corticosteroid-free remission, improvement in endoscopic histologic intestinal inflammation and maintenance of remission.
Following the results, LUCENT-2 became the first and only phase III study of an IL23 inhibitor to demonstrate the maintenance of clinical remission in UC patients.
Lilly’s shares have rallied 47.7% so far this year in comparison with the industry’s 16.4% growth.
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Please note that the data on LUCENT-2 is based on positive data from the LUCENT-1 study. Earlier in March, the company announced that the LUCENT-1 study met the primary and all key secondary endpoints in patients with moderate to severe UC who had failed conventional and/or biologic treatments. The company expects full results from LUCENT-1 and LUCENT-2 studies in early 2022.
Based on the data from LUCENT-1 and LUCENT-2 studies, Lilly anticipates submission of a biologic license application to the FDA seeking approval for mirikizumab in UC in first-half 2022.
Apart from UC, Lilly is also evaluating mirikizumab in additional phase III studies for Crohn’s disease (CD), which are underway.
While mirikizumab shows potential, we note that it is yet to be approved for any indication. In the meantime, some well-established players in the health-care industry like AbbVie (ABBV - Free Report) and J&J (JNJ - Free Report) are currently evaluating their own existing drugs in late-stage clinical studies for label expansion in UC. If these existing drugs get approval for label expansion, they will pose stiff competition to the newly approved drugs.
AbbVie is currently evaluating its own IL-23 inhibitor, Skyrizi, in a phase III study for UC. While Skyrizi is already approved in the United States for plaque psoriasis indication, AbbVie is seeking label expansion for Skyrizi in active psoriatic arthritis and CD indications, which are currently under FDA review.
In September, AbbVie also submitted a regulatory filing with the FDA seeking label expansion of another drug, Rinvoq, in UC. AbbVie’s Rinvoq is already approved by the FDA for rheumatoid arthritis and active psoriatic arthritis indications.
Skyrizi generated sales worth $2.04 billion and Rinvoq came up with $1.33-billion sales during the first nine months of 2021.
J&J is also evaluating its own IL-23 inhibitor, Tremfya (guselkumab), in ongoing phase III studies in UC indication. J&J’s Tremfya is already approved by the FDA for plaque psoriasis and active psoriatic arthritis indications.
J&J also markets Stelara, a human IL-12 and IL-23 antagonist, which has been approved by the FDA for treating moderate to severely active UC as well as CD.
GlaxoSmithKline’s earnings per share estimates for 2021 have increased from $2.82 to $3.05 in the past 60 days. The same for 2022 has increased from $3.08 to $3.25 in the past 60 days. Shares of Glaxo have risen 16.6% in the year so far.
Earnings of GlaxoSmithKline beat estimates in three of the last four quarters and missed once, with the average surprise being 15.3%.
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Lilly (LLY) Phase III Study in Ulcerative Colitis Meets Goal
Eli Lilly (LLY - Free Report) announced positive data from the phase III maintenance study, LUCENT-2, evaluating its IL-23 inhibitor, mirikizumab, for the treatment of patients with moderately-to-severely active ulcerative colitis (UC).
The LUCENT-2 study enrolled patients who completed the phase III induction study, LUCENT-1, which evaluated patients receiving mirikizumab over a period of 12 weeks. The LUCENT-2 achieved the primary endpoint of clinical remission by controlling/resolving the inflammation of the colon at one year compared to placebo.
LUCENT-2 also achieved all key secondary endpoints with statistical significance over placebo at year one in terms of achieving a reduction of bowel urgency, endoscopic remission, corticosteroid-free remission, improvement in endoscopic histologic intestinal inflammation and maintenance of remission.
Following the results, LUCENT-2 became the first and only phase III study of an IL23 inhibitor to demonstrate the maintenance of clinical remission in UC patients.
Lilly’s shares have rallied 47.7% so far this year in comparison with the industry’s 16.4% growth.
Please note that the data on LUCENT-2 is based on positive data from the LUCENT-1 study. Earlier in March, the company announced that the LUCENT-1 study met the primary and all key secondary endpoints in patients with moderate to severe UC who had failed conventional and/or biologic treatments. The company expects full results from LUCENT-1 and LUCENT-2 studies in early 2022.
Based on the data from LUCENT-1 and LUCENT-2 studies, Lilly anticipates submission of a biologic license application to the FDA seeking approval for mirikizumab in UC in first-half 2022.
Apart from UC, Lilly is also evaluating mirikizumab in additional phase III studies for Crohn’s disease (CD), which are underway.
While mirikizumab shows potential, we note that it is yet to be approved for any indication. In the meantime, some well-established players in the health-care industry like AbbVie (ABBV - Free Report) and J&J (JNJ - Free Report) are currently evaluating their own existing drugs in late-stage clinical studies for label expansion in UC. If these existing drugs get approval for label expansion, they will pose stiff competition to the newly approved drugs.
AbbVie is currently evaluating its own IL-23 inhibitor, Skyrizi, in a phase III study for UC. While Skyrizi is already approved in the United States for plaque psoriasis indication, AbbVie is seeking label expansion for Skyrizi in active psoriatic arthritis and CD indications, which are currently under FDA review.
In September, AbbVie also submitted a regulatory filing with the FDA seeking label expansion of another drug, Rinvoq, in UC. AbbVie’s Rinvoq is already approved by the FDA for rheumatoid arthritis and active psoriatic arthritis indications.
Skyrizi generated sales worth $2.04 billion and Rinvoq came up with $1.33-billion sales during the first nine months of 2021.
J&J is also evaluating its own IL-23 inhibitor, Tremfya (guselkumab), in ongoing phase III studies in UC indication. J&J’s Tremfya is already approved by the FDA for plaque psoriasis and active psoriatic arthritis indications.
J&J also markets Stelara, a human IL-12 and IL-23 antagonist, which has been approved by the FDA for treating moderate to severely active UC as well as CD.
Eli Lilly and Company Price
Eli Lilly and Company price | Eli Lilly and Company Quote
Zacks Rank & Stock to Consider
Eli Lilly presently carries a Zacks Rank #3 (Hold). A better-ranked stock in the same sector is GlaxoSmithKline (GSK - Free Report) , which currently holds a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
GlaxoSmithKline’s earnings per share estimates for 2021 have increased from $2.82 to $3.05 in the past 60 days. The same for 2022 has increased from $3.08 to $3.25 in the past 60 days. Shares of Glaxo have risen 16.6% in the year so far.
Earnings of GlaxoSmithKline beat estimates in three of the last four quarters and missed once, with the average surprise being 15.3%.