Evommune Initiates Phase 2a Proof-of-Concept Clinical Trial to Evaluate EVO101 in Atopic Dermatitis

• Safety, Tolerability and Preliminary Efficacy Data Expected in 1H'23

PALO ALTO, Calif., Sept. 28, 2022 /PRNewswire/ -- Evommune, Inc., a clinical-stage biotechnology company discovering and developing new ways to treat immune-mediated inflammatory diseases, today announced enrollment of the first patient in a Phase 2a proof-of-concept clinical trial evaluating EVO101, a novel small molecule inhibitor of interleukin 1 receptor-associated kinase 4 (IRAK4), in patients with atopic dermatitis (AD). The Phase 2a trial is a randomized, double-blind, parallel group, vehicle-controlled study which will assess the safety, tolerability and preliminary efficacy of EVO101 topical cream, 0.1% BID, in 118 adults with mild to moderate AD in clinical sites across the United States.

"People with AD often deal with incessant itch and painful skin which can disrupt sleep and lead to an overall lower quality of life. Additionally, its systemic nature means that AD is associated with a number of other serious inflammatory co-morbidities, including asthma, infection and mental health issues" said Eugene A. Bauer, M.D., Chief Medical Officer of Evommune. "Safer and more effective treatments that prevent disease progression and broadly inhibit inflammation are needed for these patients. Given EVO101's mechanism of action and the compelling preclinical and Phase 1 data, we believe that further study is well warranted and that it could, if approved, become a best-in-class treatment."

The Phase 2a study follows the successful completion of a Phase 1 healthy volunteer study which evaluated 18 adult patients with EVO101 0.1% topical cream, applied twice daily to the ventral aspect of one forearm for seven days. EVO101 was well-tolerated in all participants. In the Phase 2a study, AD patients will apply EVO101 cream twice daily for eight weeks. Primary efficacy will be assessed by changes from baseline in the Eczema Area and Severity Index (EASI).

"From inception, we have remained focused on rapidly progressing multiple candidates into proof-of-concept clinical studies," said Luis Peña, President and Chief Executive Officer of Evommune. "Our team is delivering on the first of four ongoing programs with this trial's initiation and we look forward to sharing data from this robust proof-of-concept trial in the first half of next year."

Atopic dermatitis (AD) is the most common type of eczema, affecting an estimated 30% of the U.S. population¹ – or more than 9.6 million children and about 16.5 million adults.² AD is a burdensome condition that significantly effects quality of life and overall health.³ A chronic inflammatory disease, AD is characterized by dry, itchy skin that can ooze, weep clear fluid and bleed when scratched.^1,2 In people with AD, the immune system becomes overactive, triggering inflammation that damages the skin barrier, leaving it dry and prone to itching and rashes.² Data have shown that more than 85% of people with the condition experience itching every day.² Painful skin and poor sleep caused by itching are also common.² AD is associated with many serious co-morbidities including asthma, bacterial, viral and fungal skin infections, mental health issues, like depression or anxiety, and can also have a negative impact on bone health.^1,3,4 AD can be difficult to treat and there is currently no cure. Currently available treatments include topical corticosteroids, non-steroidal topicals, biologics and Janus kinase (JAK) inhibitors.^2,5 

EVO101 is a novel, small molecule inhibitor of interleukin 1 receptor-associated kinase 4 (IRAK4). This protein plays a key role in innate immune responses, as it is critical for both Toll-like receptor and IL-1 family cytokine signaling. Importantly, IL-1 family cytokines also amplify and drive adaptive inflammatory responses. EVO101 has been shown to potently inhibit inflammation in animal models, and in a variety of human skin models of innate and adaptive immunity. IRAK4 is viewed as a valuable target for the treatment of a broad range of inflammatory diseases. While the initial focus will be on studying EVO101 in atopic dermatitis, it also may have utility in the treatment of Behçet's disease, pustular psoriasis, ocular rosacea and conjunctivitis. The inhibition of IRAK4 signaling is expected to broadly and potently suppress inflammation and provide rapid resolution of symptoms.

Evommune, Inc. is a private R&D company creating game-changing science to treat immune-mediated inflammatory diseases. The company is evolving immunology through its unique human tissue-based approach to discovering, developing, and delivering therapies that address symptoms and halt progressive disease. Evommune was founded in 2020 by an industry-leading team of R&D experts and is headquartered in Palo Alto, California. For more information, visit www.evommune.com.

¹ "Eczema (Atopic Dermatitis)." National Institute of Infectious Diseases. Retrieved from https://www.niaid.nih.gov/diseases-conditions/eczema-atopic-dermatitis. Accessed July 1, 2022.

² "Atopic Dermatitis." National Eczema Association. Retrieved from https://nationaleczema.org/eczema/types-of-eczema/atopic-dermatitis/. Accessed July 1, 2022.

³ "American Academy of Dermatology Guidelines: Awareness of comorbidities associated with atopic dermatitis in adults." American Academy of Dermatology. Retrieved from https://www.jaad.org/article/S0190-9622(22)00080-9/fulltext#secsectitle0075. Accessed July 1, 2022.

⁴ "Eczema and Emotional Wellness." National Eczema Association. Retrieved from https://nationaleczema.org/eczema-emotional-wellness/. Accessed July 1, 2022. 

⁵ "Available Eczema Treatments." National Eczema Association. Retrieved from https://nationaleczema.org/eczema/treatment/. Accessed July 1, 2022.

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SOURCE Evommune, Inc.