Phase II results of MoonLake’s sonelokimab suggest superiority to the competition. Funds raised in the stock offering will support Phase III trials with an anticipated launch in 2027.
Pictured: Analyst pointing to stock chart / iStock, tadamichi
Fresh on the heels of a Phase II data drop, MoonLake Immunotherapeutics announced Monday plans to raise capital with a public offering of $250 million of its shares.
MoonLake’s Phase II results had investors excited, nearly doubling its stock price on Monday. The trial focused on its novel trivalent nanobody, sonelokimab (SLK), to treat hidradenitis suppurativa (HS), an autoinflammatory disease that affects hair follicles, causing painful lumps and abscesses, most often in areas where skin touches skin.
The immunosuppressive agent binds to IL-17A, IL17F and the IL-17A/F heterodimer; it’s shaping up to be a serious contender in the HS market. Currently, only Humira is approved for the treatment of HS in the U.S. but Novartis’ Cosentyx and UCB’s Bimzelx are hot on the trail.
MoonLake’s mid-stage data for SLK suggests it could be even more effective than the competition. SLK produced a 43.3% response rate on HiSCR75 and a 66% response rate in HiSCR50, measures used to indicate a 75% or 50% reduction from baseline in total abscess or inflammatory nodule count. Other company trials have used HiSCR50 as a primary endpoint with Cosentyx ranging from 42% to 46% and Humira 42% to 59% response rates, respectively.
The company’s SEC filing states SLK, relative to placebo, “reaches the highest clinical activity among all other therapies tested in similarly stringent pivotal-like trials.”
The Phase II study included a Humira arm, somewhat supporting the claims of superiority. Jefferies analyst Kelly Shi wrote in a note that MoonLake’s asset “appears more active vs Humira on all fronts.”
MoonLake also touted the treatment’s favorable benefit-risk profile and a statistically significant reduction in patient-reported outcomes, particularly pain, versus placebo.
The next step for MoonLake is Phase III testing in HS, one or two trials, depending on regulatory discussions.
In addition to the $250 million, the public offering includes a 30-day option for an additional $37.5 million of its shares. The proceeds will fund the trials with a planned launch in 2027, first in HS and then with plans for “a wealth of potential indications to further pursue,” according to the company’s presentation.
While Humira has been a successful treatment for many patients, it loses efficacy over time for some and may not be safe for those with other health conditions. TNF-a inhibitors, like Humira, are not safe for patients with demyelinating diseases like multiple sclerosis. These factors make expanding the market to other inhibitors an important goal.
MoonLake went public in 2021 via a SPAC merger with Helix Acquisition, the same year it launched. Sonelokimab, its sole pipeline asset, was in-licensed from Merck KGaA. Merck took a minority stake in the company at the time and is eligible for milestone payments and royalties on net sales of the antibody.
The company’s presentation put the 2022 HS biologics market at $1.6 billion, with projections for growth to $10.1 billion by 2035.
Sonelokimab is also Phase III-ready for testing in psoriasis and a Phase II trial is underway for psoriatic arthritis. These are indications for which Cosentyx and Humira. The drugs already have FDA approvals for immunoinflammatory conditions.
Kate Goodwin is a freelance life science writer based in Des Moines, Iowa. She can be reached at kate.goodwin@biospace.com and on LinkedIn.
