MoonLake Immunotherapeutics (NASDAQ: MTLX) saw its stock price surge 70%+ on Monday after the company announced encouraging top-line results from its global Phase 2 MIRA trial evaluating the efficacy and safety of its Nanobody® sonelokimab in patients with moderate-to-severe hidradenitis suppurativa (HS).

The trial, which included 234 patients, represents a significant milestone in HS clinical development as the first randomized, double-blind, placebo-controlled trial to utilize Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) as its primary endpoint, a higher measure of clinical response compared to previous trials.

The MIRA trial successfully met its primary endpoint, with a significantly greater proportion of patients treated with sonelokimab 120mg and 240mg achieving HiSCR75 compared to those on placebo at week 12. The analysis utilized the most stringent type of analysis for such trials, intent-to-treat non-responder imputation (ITT-NRI).

Both doses performed similarly, with the 120mg dose providing the highest delta on HiSCR75 and HiSCR50. The results suggest that, at week 12, sonelokimab demonstrates the highest clinical activity among all other therapies tested in similarly rigorous trials.

In addition to meeting the primary endpoint, the company said that the trial also showed statistically significant improvements in secondary endpoints, including HiSCR90, International Hidradenitis Suppurativa Severity Score System (IHS4), abscess/nodule and draining tunnel counts, and patient-reported pain and quality of life outcomes at week 12.

The 120mg dose of sonelokimab, which has been identified as optimal in treating psoriasis, demonstrated exceptional performance, highlighting the advantages of using a smaller biologic with albumin-binding capacity to inhibit IL-17A and IL-17F for the treatment of inflammatory diseases.

The safety profile of sonelokimab remained consistent with previously reported studies, with no new safety signals observed. The positive results from the MIRA trial provide MoonLake with increased confidence as it aspires to become a leader in the inflammation and immunology space, elevating outcomes for patients with HS and other inflammatory diseases.

MoonLake's founder and CEO, Jorge Santos da Silva, expressed his satisfaction with the trial results, emphasizing the company's ambitious goal to surpass the achievements of competitors in pivotal-like trials. The positive outcome of the Phase 2 MIRA trial demonstrates the potential of sonelokimab to revolutionize the treatment of chronic inflammatory diseases.

Dr. Kristian Reich, MoonLake's Chief Scientific Officer, highlighted the groundbreaking nature of the MIRA trial results, establishing a new era in the treatment of chronic inflammatory diseases. The smaller size of Nanobodies®, compared to traditional antibodies, offers advantages in tissue penetration, making them effective in diseases like hidradenitis suppurativa and psoriatic arthritis. Sonelokimab's unique mode of action in inhibiting both IL-17A and IL-17F further validates its potential as a promising treatment option.

Dr. Alexa B. Kimball, the lead investigator of the MIRA trial, emphasized the urgent need for new treatment options for patients with hidradenitis suppurativa. The positive clinical responses observed with sonelokimab in the Phase 2 trial provide hope for improved outcomes and demonstrate its potential as a future treatment option.

MoonLake says that the MIRA trial will continue to collect data up to week 24, including longer-term efficacy and safety results, as well as data from patients switching to sonelokimab from the placebo and adalimumab arms. The full results of the MIRA trial will be published in a peer-reviewed medical journal and presented at an upcoming scientific meeting, providing further insights into the potential of sonelokimab.

MoonLake Immunotherapeutics is dedicated to unlocking the potential of sonelokimab, a Nanobody® with unique therapeutic properties, to address inflammatory diseases with unmet medical needs. Sonelokimab's ability to inhibit IL-17A and IL-17F and its smaller size offer advantages over traditional antibodies, making it a promising candidate for the treatment of conditions such as hidradenitis suppurativa and psoriatic arthritis. With a focus on improving outcomes for patients, MoonLake aims to become a leader in the field of inflammation and immunology.

Hidradenitis suppurativa is a chronic, inflammatory, and debilitating skin disease that affects a significant portion of the global population.

MoonLake's MIRA trial has provided hope for patients suffering from this condition, offering the potential for improved treatment options and enhanced quality of life. The positive results bring optimism for the future, as innovative therapies like sonelokimab continue to advance in their clinical development, offering new horizons for patients with inflammatory diseases.

Shares of MoonLake Immunotherapeutics trade on the NASDAQ under the ticker symbol MTLX. For more information visit www.moonlaketx.com.