In a recent interview with PharmaShots, Dr. Lotus Mallbris, the Vice President of Immunology Development at Eli Lilly shares her insights and highlights on Baricitinib.

Shots:

• If approved, Baricitinib could be the first JAK inhibitor in the EU for adults with moderate to severe AD. EC's decision is expected in the next one-two months.
• Lilly is evaluating Baricitinib for SLE, for which the clinical development program received FDA's FT designation. Lilly also has two ongoing P-III trials for Baricitinib for AA and evaluating it for the treatment of hospitalized patients with COVID-19 in another two P-III studies
• Lilly's launch of Open Innovation Challenge Transforming Atopic Dermatitis Care is a call for eligible individuals, teams, or organizations to submit novel technology-based digital solutions that are either conceptual or in early stages of development to transform the care for those living with inflammatory skin diseases like AD

Tuba: What are the milestones discovered in the grant of the CHMP's positive opinion?

Lotus: The European Medicines Agency's (EMA) positive CHMP opinion marks an important step in the European regulatory approval process for baricitinib. If approved, baricitinib could become the first oral JAK inhibitor available to treat adult patients with moderate to severe atopic dermatitis (AD). Due to the high unmet need in treatment options for adult patients with AD, this positive opinion brings us closer to providing treatments to those who need it most.

The positive opinion was based on Lilly's Phase 3 BREEZE-AD clinical development program for baricitinib evaluating the medicine's potential to treat AD. The BREEZE-AD clinical development program assessed the efficacy and safety of baricitinib, both as monotherapy (the international BREEZE-AD1 and BREEZE-AD2 studies and BREEZE-AD5 in North America) and in combination with topical corticosteroids (BREEZE-AD4 and BREEZE-AD7), in patients with moderate to severe AD who are candidates for systemic therapy. BREEZE-AD4 was conducted in adult patients with moderate to severe AD, with a contraindication, previous failure or intolerance to cyclosporine.

Tuba: Are you planning to target other inflammatory & autoimmune disease apart from RA and AD?

Lotus: Yes, Lilly continues to enroll Phase 3 trials for baricitinib for the investigational treatment of systemic lupus erythematous (SLE), for which the clinical development program received Fast Track designation from the Food and Drug Administration (FDA). Lilly also has two ongoing Phase 3 trials for baricitinib for the investigational treatment of alopecia areata (AA), and the clinical development program received Breakthrough Therapy designation from the FDA earlier this year.

Also for your awareness, baricitinib is being studied for the treatment of hospitalized patients with COVID-19 in two Phase 3 trials. Lilly entered into an agreement with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), to study baricitinib in NIAID's Adaptive COVID-19 Treatment Trial. In addition, Lilly initiated its own Phase 3 randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of baricitinib in hospitalized adults with COVID-19.

If approved, Baricitinib could become the first oral JAK inhibitor available to treat adult patients living with moderate to severe AD in Europe. 

Tuba: As Baricitinib (OLUMIANT) is approved in 70+ countries for RA. How many other geographies are in focus for AD except EU?

Lotus: We look forward to working with other regulatory authorities to bring a much-needed treatment option to market for adults living with this disease.

Tuba: How the approval in the EU for AD helps you to build the momentum in this indication?

Lotus: We are thrilled with the EMA's positive CHMP opinion. The agency's opinion marks an important step in the European regulatory approval process for baricitinib. If approved, baricitinib could become the first oral JAK inhibitor available to treat adult patients living with moderate to severe AD in Europe. 

Tuba: Notably, Sanofi's Dupixent and Pfizer's Eucrisa is already approved in AD. What are the other potential threats to Baricitinib in AD and how it is superior to others?

Lotus: Since there are currently no head-to-head studies comparing baricitinib with other systemic treatment options, we can only discuss the findings of our own clinical trials and are not in the position to directly compare and discuss the efficacy and safety of baricitinib with that of other companies products. We recommend caution against indirect comparisons of systemic treatment approved or in development for AD due to the considerable limitations related to study designs, patient characteristics, scales for skin involvement, and assessments and efficacy assessments. 

Baricitinib could be the first oral JAK inhibitor and the first approved oral systemic treatment available for AD in more than 20 years.  Baricitinib may be an important additional offering for those not ready to take an injectable biologic. We expect dermatologists will use both oral and injectable agents to treat AD, similar to what occurs when treating psoriasis.

Image Source: Whole Health Library

Tuba: Lilly is exploring the Baricitinib for the treatment of adults with moderate to severe AD. What about its efficacy in children, infants, and pregnant ladies?

Lotus: Our current focus for baricitinib in AD is for the treatment of adult patients with moderate to severe disease.

Tuba: Discuss Eli Lilly's working in digital space in enhancing the QoL of patients with Inflammatory Skin Disease

Lotus: Lilly, we believe today's most advanced digital technologies can lead to personalized and actionable insights, new channels of engagement between patients and their health care providers (HCPs), and improved self-management solutions for patients  all of which can contribute to better health.

One example of our ongoing commitment in this space is the recent launch of our Open Innovation Challenge  Transforming Atopic Dermatitis Care. This innovation challenge is calling for eligible individuals, teams, or organizations to submit novel technology-based digital solutions  mobile apps, sensors and wearables, connected drug delivery devices, real-time monitoring, algorithms, digital games, etc.  that are either conceptual or in early stages of development, with potential to make a meaningful difference in transforming the care for those living with inflammatory skin diseases, such as atopic dermatitis. People are exploring and enhancing novel and innovative digital solutions and ideas every day and we hope this program will help identify new ways that Lilly can partner with others to help enhance the quality of life for people with inflammatory skin disease.

Tuba: Is there any specific digital tool (sensors, wearables, app) you are working on for AD and other indications?

Lotus: We are investigating several different approaches to enhance not only patient care, but also how we recruit, enroll, and conduct clinical research. These include the use of wearable sensors to collect biometric data and help us understand how patients respond to medications; leveraging artificial intelligence to better diagnose certain GI issues; and, determining how disease management tools can help provide a better understanding of one's condition, which could lead to better discussions with their healthcare professional.

Lilly's digital health initiatives expand across Lilly's core therapeutic areas including diabetes, oncology, immunology, pain, and neurodegeneration. Our strategy is rooted in creating a better experience for people by providing on-demand information, actionable insights, and support aimed at improving health outcomes through personalized interventions.

We are partnering with organizations and conducting research to better understand how digitally-enabled care products and solutions can help people with chronic illnesses. We are interested in digital solutions across a broad spectrum of the patient health care experience which can support improved diagnosis, more integrated treatment management, and novel clinical research data insights.  We have many exciting projects underway and look forward to sharing more information.

Tuba: Can we have a discussion on a commercial strategy of Baricitinib in AD? What would be the pricing of the therapy, if approved in the EU?

Lotus: Lilly does not speculate on future business performance outside of quarterly earnings reports and investor relations announcements.

About Dr. Lotus Mallbris:

Lotus Mallbris, M.D., Ph.D., is the Vice President and Global Head of Immunology Product Development at Eli Lilly. She has joined Lilly in 2015 and leads the company's global clinical development and global medical affairs teams across the dermatology, rheumatology, and gastroenterology fields.