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Lilly's Plaque Psoriasis Candidate Meets Phase III Study Goals
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Eli Lilly and Company (LLY - Free Report) announced that the phase III OASIS-2 study evaluating its pipeline candidate mirikizumab in patients with moderately-to-severely active plaque psoriasis met the primary and secondary endpoints.
The company is developing the candidate as a treatment for plaque psoriasis under the OASIS program, which includes two late-stage studies — OASIS-1 and OASIS-2. The company completed the OASIS -1 study last year.
In the OASIS-2 study, the candidate met the primary and all key secondary endpoints versus placebo at week 16 as well as all key secondary endpoints versus Novartis' (NVS - Free Report) Cosentyx (secukinumab) at week 16 and week 52, including superiority in skin clearance at week 52.
Data from the study showed that treatment with mirikizumab led to at least a two-point improvement on Static Physician's Global Assessment (sPGA) score and at least a 90% improvement from baseline in Psoriasis Area and Severity Index (PASI 90) at week 16 compared to placebo in significantly higher proportion of patients. The patients receiving mirikizumab also had a score of 0 or 1 on sPGA. This was the study’s primary endpoint.
While 79.7% and 74.4% of patients receiving treatment with the candidate achieved required sPGA score and PASI 90, respectively, the proportion for placebo was 6.3% on both scales.
Apart from placebo, the study also evaluated mirikizumab for non-inferiority and superiority to Novartis’ blockbuster autoimmune drug, Cosentyx (secukinumab), at week 16 and 52, respectively, as key secondary endpoints. Data showed that the proportion of patients achieving a score of 0 or 1 on sPGA and skin clearance as measured by PASI 90 were numerically higher for mirikizumab for both time points.
Detailed data from the study will be presented at future medical congresses. In April, the company announced that a phase III study evaluating mirikizumab as a treatment for moderate-to-severe plaque psoriasis over 52 weeks met primary and key secondary endpoints. It plans to submit data from OASIS-1 and 2 studies to regulatory authorities around the world in a bid to pursue approval for the candidate.
Lilly’s shares have risen 26.3% this year so far compared with the industry’s increase of 2.6%.
Apart from plaque psoriasis, the company is also evaluating mirikizumab as a potential treatment for inflammatory bowel diseases including ulcerative colitis and Crohn's disease in phase III studies.
Please note that although the autoimmune or inflammatory disease field has significant opportunity, competition can be stiff. AbbVie’s (ABBV - Free Report) Humira is the leading drug in this field generating tens of billions of dollars annually. However, the drug is set to face generic competition from 2023 onward in the United States. Meanwhile, AbbVie is developing its marketed inflammatory drug, Skyrizi, for label expansion in other inflammatory indications. The drug was approved for treating plaque psoriasis in April 2020. Moreover, J&J (JNJ - Free Report) has several blockbuster drugs approved for treating either UC, CD or plaque psoriasis. A few other biotechs have approved drugs or are developing their pipeline candidates targeting inflammatory indications.
Be among the early investors in the new type of device that experts say could impact society as much as the discovery of electricity. Current technology will soon be outdated and replaced by these new devices. In the process, it’s expected to create 22 million jobs and generate $12.3 trillion in activity.
A select few stocks could skyrocket the most as rollout accelerates for this new tech. Early investors could see gains similar to buying Microsoft in the 1990s. Zacks’ just-released special report reveals 8 stocks to watch. The report is only available for a limited time.
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Lilly's Plaque Psoriasis Candidate Meets Phase III Study Goals
Eli Lilly and Company (LLY - Free Report) announced that the phase III OASIS-2 study evaluating its pipeline candidate mirikizumab in patients with moderately-to-severely active plaque psoriasis met the primary and secondary endpoints.
The company is developing the candidate as a treatment for plaque psoriasis under the OASIS program, which includes two late-stage studies — OASIS-1 and OASIS-2. The company completed the OASIS -1 study last year.
In the OASIS-2 study, the candidate met the primary and all key secondary endpoints versus placebo at week 16 as well as all key secondary endpoints versus Novartis' (NVS - Free Report) Cosentyx (secukinumab) at week 16 and week 52, including superiority in skin clearance at week 52.
Data from the study showed that treatment with mirikizumab led to at least a two-point improvement on Static Physician's Global Assessment (sPGA) score and at least a 90% improvement from baseline in Psoriasis Area and Severity Index (PASI 90) at week 16 compared to placebo in significantly higher proportion of patients. The patients receiving mirikizumab also had a score of 0 or 1 on sPGA. This was the study’s primary endpoint.
While 79.7% and 74.4% of patients receiving treatment with the candidate achieved required sPGA score and PASI 90, respectively, the proportion for placebo was 6.3% on both scales.
Apart from placebo, the study also evaluated mirikizumab for non-inferiority and superiority to Novartis’ blockbuster autoimmune drug, Cosentyx (secukinumab), at week 16 and 52, respectively, as key secondary endpoints. Data showed that the proportion of patients achieving a score of 0 or 1 on sPGA and skin clearance as measured by PASI 90 were numerically higher for mirikizumab for both time points.
Detailed data from the study will be presented at future medical congresses. In April, the company announced that a phase III study evaluating mirikizumab as a treatment for moderate-to-severe plaque psoriasis over 52 weeks met primary and key secondary endpoints. It plans to submit data from OASIS-1 and 2 studies to regulatory authorities around the world in a bid to pursue approval for the candidate.
Lilly’s shares have risen 26.3% this year so far compared with the industry’s increase of 2.6%.
Apart from plaque psoriasis, the company is also evaluating mirikizumab as a potential treatment for inflammatory bowel diseases including ulcerative colitis and Crohn's disease in phase III studies.
Please note that although the autoimmune or inflammatory disease field has significant opportunity, competition can be stiff. AbbVie’s (ABBV - Free Report) Humira is the leading drug in this field generating tens of billions of dollars annually. However, the drug is set to face generic competition from 2023 onward in the United States. Meanwhile, AbbVie is developing its marketed inflammatory drug, Skyrizi, for label expansion in other inflammatory indications. The drug was approved for treating plaque psoriasis in April 2020. Moreover, J&J (JNJ - Free Report) has several blockbuster drugs approved for treating either UC, CD or plaque psoriasis. A few other biotechs have approved drugs or are developing their pipeline candidates targeting inflammatory indications.
Eli Lilly and Company Price
Eli Lilly and Company price | Eli Lilly and Company Quote
Zacks Rank
Lilly currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Biggest Tech Breakthrough in a Generation
Be among the early investors in the new type of device that experts say could impact society as much as the discovery of electricity. Current technology will soon be outdated and replaced by these new devices. In the process, it’s expected to create 22 million jobs and generate $12.3 trillion in activity.
A select few stocks could skyrocket the most as rollout accelerates for this new tech. Early investors could see gains similar to buying Microsoft in the 1990s. Zacks’ just-released special report reveals 8 stocks to watch. The report is only available for a limited time.
See 8 breakthrough stocks now>>