8-K: MoonLake Immunotherapeutics Receives Positive Regulatory Feedback for Phase 3 Program of Sonelokimab in Hidradenitis Suppurativa

MoonLake Immunotherapeutics has secured positive feedback from both the FDA and EMA regarding its Phase 3 program for sonelokimab in hidradenitis suppurativa, paving the way for a pivotal trial.

Summary

• MoonLake Immunotherapeutics has received positive feedback from both the FDA and EMA on its Phase 3 program for sonelokimab (SLK) in hidradenitis suppurativa (HS).
• The regulatory bodies have agreed on the study design, patient population, and endpoints for the Phase 3 trial.
• The Phase 3 program, named VELA, will enroll 800 patients and will use a 120mg dose of SLK, similar to the Phase 2 trial.
• The Phase 3 trial will compare SLK to placebo over 16 weeks, with the placebo group then transitioning to SLK.
• The primary endpoint, HiSCR75, and key secondary endpoints will be assessed at week 16.
• The VELA trial is designed to run for 52 weeks, followed by an open-label extension.
• The first patient is expected to be randomized in Q2 2024, with the primary endpoint readout expected in mid-2025.
• MoonLake also plans an end-of-Phase 2 meeting with the FDA for its psoriatic arthritis (PsA) program in Q2 2024 and to begin the Phase 3 program in Q4 2024.

Sentiment

Score: 8

Explanation: The document conveys a positive sentiment due to the successful regulatory feedback and clear path forward for the Phase 3 program. The company is also progressing its psoriatic arthritis program, which is a positive sign.

Positives

• The positive feedback from both the FDA and EMA provides a clear regulatory path for sonelokimab in hidradenitis suppurativa.
• The Phase 3 trial design is similar to the successful Phase 2 trial, increasing the likelihood of positive results.
• The use of a single 120mg dose simplifies the trial and aligns with previous findings.
• The large patient population of 800 in the Phase 3 trial, combined with Phase 2 data, should provide robust data for regulatory submissions.
• The company is moving forward with its psoriatic arthritis program, with plans for an end-of-Phase 2 meeting and a Phase 3 trial start in 2024.

Risks

• There are risks associated with enrolling patients in clinical trials.
• Future interactions with regulatory agencies are uncertain.
• The company relies on third parties to conduct and support its preclinical studies and clinical trials.
• Actual results could differ materially from those anticipated in forward-looking statements.

Future Outlook

MoonLake anticipates continued progress in its clinical programs, with the Phase 3 trial for hidradenitis suppurativa commencing in Q2 2024 and the primary endpoint readout expected in mid-2025. The company also plans to advance its psoriatic arthritis program with an end-of-Phase 2 meeting in Q2 2024 and a Phase 3 trial start in Q4 2024.

Management Comments

• Dr. Jorge Santos da Silva, Chief Executive Officer of MoonLake Immunotherapeutics, said: 'The favorable response from both the FDA and EMA aligns with the strengths we have consistently highlighted in our trial programs and outlines a clear regulatory path for sonelokimab in hidradenitis suppurativa.'
• Dr. Jorge Santos da Silva also stated: 'We deeply appreciate the support from both agencies and continue to work swiftly to ramp up the Phase 3 program in HS, named VELA.'

Industry Context

This announcement is significant as it demonstrates progress in the development of a new treatment option for hidradenitis suppurativa, a condition with a high unmet need. The positive feedback from regulatory agencies suggests a potential for sonelokimab to become a viable treatment option in the future. The company is also progressing its psoriatic arthritis program, indicating a broader focus on inflammatory diseases.

Comparison to Industry Standards

• The Phase 2 MIRA trial used HiSCR75 as its primary endpoint, a higher measure of clinical response than the HiSCR50 used in other clinical trials, indicating a potentially more effective treatment.
• The company is comparing sonelokimab to placebo in the Phase 3 trial, which is a standard approach in clinical trials.
• The company is also using adalimumab as an active reference arm in the Phase 2 MIRA trial, which is a common practice in clinical trials for hidradenitis suppurativa.
• The company is also comparing sonelokimab to secukinumab in a Phase 2b trial in patients with moderate-to-severe plaque-type psoriasis, which is a common practice in clinical trials for psoriasis.

Stakeholder Impact

• Shareholders will likely view the positive regulatory feedback as a positive development.
• Patients with hidradenitis suppurativa may benefit from a new treatment option.
• Physicians will have a potential new treatment option for their patients.
• Employees of MoonLake will be working on advancing the clinical programs.

Next Steps

• The company will begin enrolling patients in the Phase 3 VELA trial in Q2 2024.
• The company will have an end-of-Phase 2 meeting with the FDA regarding its psoriatic arthritis program in Q2 2024.
• The company will begin the Phase 3 program for psoriatic arthritis in Q4 2024.
• The company will provide further details on both the HS and PsA programs during an upcoming R&D Day.

Key Dates

Keywords

sonelokimab, hidradenitis suppurativa, FDA, EMA, Phase 3 trial, clinical trial, Nanobody, psoriatic arthritis, regulatory approval, VELA trial