MoonLake (NASDAQ: MLTX), a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, has announced positive top-line results from its global phase 2 MIRA trial. The trial (“M1095-HS-201”) evaluated the efficacy and safety of the Nanobody(R) Sonelokimab in patients with moderate-to-severe hidradenitis suppurativa (“HS”). MoonLake’s shares closed nearly $20.00 up on the day to $45.95 following the recent news. “As part of our efforts to elevate outcomes for patients, we set an ambitious goal for our Nanobody(R) Sonelokimab to ‘meet or beat’ the best results shown in pivotal-like trials of competitors,” said Jorge Santos da Silva, PhD, founder and CEO of MoonLake. “We have achieved our ‘beat’ goal with the positive outcome of the phase 2 MIRA trial. In doing so, we have raised the bar for what can be accomplished for HS and these positive topline data provide us with even greater confidence as we look forward to our next steps and our aspiration to become a leader in the inflammation and immunology space.”
MoonLake is not the only company pursuing anti-IL-17 nanobody therapies. BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV) is a biotechnology company focused on developing, manufacturing and commercializing innovative immunotherapeutic products primarily for the treatment of infectious and autoimmune diseases. BVXV is positioning in a market hungry for nanobodies that target IL-17, demonstrated by the success of MoonLake, which, at a market value currently hundreds of times higher than BVXV, speaks to BiondVax’s massive upside potential. In comparison to MoonLake’s nanobody, BiondVax’s candidate does not require conjugation of two antibodies with a linker nor does it require attachment to albumin, so it is, therefore, easier and cheaper to produce. BiondVax’s nanobody is planned to be injected directly into the psoriatic lesions (not systemic) and is therefore expected to have a better safety profile and is intended for use in mild to moderate patients, a significantly greater population of patients compared to MoonLake’s case targeting severe patients. Finally, MoonLake’s MIRA trial does not pertain to psoriasis, but to the orphan disease HS, whose market is much smaller. While BiondVax is initially targeting IL-17 for treatment of psoriasis, its plan for the IL-17 nanobody includes addressing additional relevant diseases such as HS and psoriatic arthritis. The company plans to complete preclinical tests this year, and initiate clinical trials in 2024.
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About MoonLake Immunotherapeutics
MoonLake is a clinical-stage biopharmaceutical company unlocking the potential of sonelokimab, a novel investigational Nanobody(R) for the treatment of inflammatory disease, to revolutionize outcomes for patients. Sonelokimab inhibits IL-17A and IL-17F by inhibiting the IL-17A/A, IL-17A/F, and IL-17F/F dimers that drive inflammation. The company’s focus is on inflammatory diseases with a major unmet need, including hidradenitis suppurativa and psoriatic arthritis – conditions affecting millions of people worldwide with a large need for improved treatment options. MoonLake was founded in 2021 and is headquartered in Zug, Switzerland. Further information is available at www.MoonLaketx.com.
NOTE TO INVESTORS: The latest news and updates relating to BVXV are available in the company’s newsroom at https://ibn.fm/BVXV
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