Alumis Seeks IPO to Fund Phase III Trials for Sotyktu Rival

Alumis, a biotechnology firm headquartered in San Francisco, has filed for an initial public offering (IPO) to secure funds for Phase III clinical trials of its leading therapeutic candidate, ESK-001. This prospective treatment aims to provide an alternative to Bristol Myers Squibb’s Sotyktu (deucravacitinib) and Takeda’s TAK-279, particularly targeting conditions such as plaque psoriasis, systemic lupus erythematosus, and non-infectious uveitis.

Alumis is currently working on two inhibitors of the TYK2 enzyme. The first of these, ESK-001, is trailing behind Sotyktu and TAK-279 in development. However, Alumis posits that ESK-001 is a second-generation TYK2 inhibitor that may offer advantages over these existing treatments. Alumis is seeking to leverage public funding to validate ESK-001's potential through its IPO. In March 2024, the biotech company successfully raised $259 million in a Series C funding round.

Though the exact amount Alumis intends to raise through its IPO remains undisclosed in its filing with the Securities and Exchange Commission (SEC), the company has applied to list its common stock on the Nasdaq Global Market under the ticker symbol ALMS. Alumis aims to use the IPO proceeds to achieve topline Phase III results for ESK-001 in plaque psoriasis and to advance mid-stage studies for systemic lupus erythematosus and non-infectious uveitis. Additionally, the funds will support a Phase I clinical trial for A-005, another TYK2 inhibitor that is designed to penetrate the central nervous system for the treatment of neurological diseases.

Alumis argues that its lead candidate, ESK-001, achieves more comprehensive TYK2 inhibition than its rivals, which could translate into better therapeutic outcomes. According to the company’s IPO filing, the approved dosage of Sotyktu only provides partial target coverage, and while higher doses could improve efficacy in treating psoriasis and psoriatic arthritis, they have been linked to skin rashes in up to 9% of patients. In contrast, Alumis claims that ESK-001 has demonstrated a lower incidence of skin rashes in humans even at doses that offer robust target inhibition.

The company plans to initiate two Phase III trials for ESK-001 in plaque psoriasis in the latter half of 2024, with the aim of reporting topline data by 2026. These trials will compare ESK-001 to a placebo over a 16-week period and to Amgen’s Otezla over 24 weeks. The European Medicines Agency has provided feedback on the trial durations, which Alumis must address through comparator trials. These changes could potentially delay regulatory approval in the EU and increase resource requirements. Nevertheless, Alumis does not anticipate incorporating this data into its U.S. approval submission.

This IPO filing comes amid a general slowdown in biotechnology IPOs on U.S. stock markets. Although there was a surge in IPO filings earlier in the year, suggesting a potential reopening of the market following a slow 2023, the pace has since decreased significantly. Alumis’ move to go public will be closely watched as an indicator of market sentiment towards biotech investments.

Overall, Alumis is positioning itself as a key player in developing next-generation TYK2 inhibitors, with a focus on providing improved therapeutic options for patients suffering from plaque psoriasis and other immune-related conditions.