Eli Lilly's IL-23 inhibitor lebrikizumab successfully treats atopic dermatitis Phase 3 study

In the field of atopic dermatitis (AD), Sanofi/Regeneron's ace biologic Dupixent will usher in another competitor
.
On December 21, Eli Lilly announced the data of the third key phase 3 clinical study ADhere, the IL-23 targeted monoclonal antibody lebrikizumab for the treatment of moderate to severe AD patients
.
The results show that the combination of lebrikizumab and topical corticosteroids (TCS) has a significant effect
.
According to an announcement issued by Eli Lilly, lebrikizumab reached all primary and secondary endpoints in the ADhere study
.
Among them, the primary end point is the improvement of skin lesion removal at the 16th week of treatment, and the secondary end points include: improving skin, alleviating itching, improving the interference of itching on sleep and quality of life
.
In January 2020, Eli Lilly acquired Dermira for US$1.
1 billion and obtained this anti-IL-13 antibody
.
At that time, Dermira tested lebrikizumab in a phase 2b clinical trial, and showed that it was as effective as Dupixent in improving disease symptoms
.
After taking over lebrikizumab, Eli Lilly hopes to cultivate it as a successor to Dupixent, the dermatology ace biological agent
.
In terms of medication, lebrikizumab is more convenient.
It can be administered every 2 or 4 weeks, while Dupixent is administered once a week
.
Dupixent was jointly developed by Sanofi and Regeneron, bringing billions of dollars in sales to both parties each year.
In the first three quarters of 2021, Sanofi’s recorded sales reached 3.
7 billion euros (approximately 4.
2 billion US dollars).
)
.
To prove this, Eli Lilly is collecting a lot of data
.
The latest Phase 3 results released this time supplement the results of the 2 Phase 3 clinical studies (ADvocate 1 and ADvocate 2) announced in August
.
In the latter two studies, the efficacy and safety of lebrikizumab as a monotherapy were evaluated
.
The results showed that these two studies also reached all primary and secondary endpoints: lebrikizumab treatment significantly improved skin lesion removal, alleviated itching, improved the interference of itching on sleep, and improved the quality of life
.
In the latest ADhere trial, patients who received TCS treatment and could not adequately control their disease symptoms were enrolled, and the results were as good as the previous two phase 3 studies
.
The safety is consistent with previous research
.
The most common adverse events were conjunctivitis and headache
.
Eli Lilly plans to release more data on these three trials at a scientific conference in 2022
.
At that time, the company will also submit a listing application for lebrikizumab in the treatment of moderate to severe AD with its partner Almirall
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In terms of the distribution of lebrikizumab rights, Eli Lilly has the rights to the US market and other markets outside Europe, and Almirall has the rights to the European market for dermatological indications (including AD)
.
The original research company of lebrikizumab is Roche, and the primary indication developed for lebrikizumab is asthma
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However, the results of two phase 3 clinical trials in 2016 were positive and negative
.
In 2017, Roche licensed lebrikizumab to Dermira with an advance payment of US$80 million
.
This means that if lebrikizumab is successfully listed and reaches its commercialization target, Roche will receive a milestone payment of more than $1 billion
.
Dupixent has been approved for the treatment of AD, asthma, and chronic sinusitis with nasal polyps
.
Dermira considered multiple indications when signing the license agreement with Roche, but so far, only the AD indication has been included in Eli Lilly's development pipeline
.
Roche reserves the right to treat interstitial lung diseases with lebrikizumab, including idiopathic pulmonary fibrosis
.
On Roche’s website, lebrikizumab does not list any indications
.
Reference source: Lillys atopic dermatitis med scores another late-stage win in attempt to outdo Dupixent