SOUTH SAN FRANCISCO - Alumis Inc. (NASDAQ:ALMS), a clinical-stage biopharmaceutical company, has announced positive interim results from a Phase 2 trial of ESK-001, its investigational oral treatment for moderate-to-severe plaque psoriasis. These findings were presented at the European Academy of Dermatology & Venereology Congress this week.
The 28-week data from the open-label extension (OLE) period of the Phase 2 STRIDE trial indicated that ESK-001 was generally well tolerated. At the top dose of 40 mg twice daily, a significant majority of patients achieved a 75% reduction in the Psoriasis Area and Severity Index (PASI 75), a primary measure of clinical efficacy.
The interim analysis, as of March 1, 2024, showed that 93% of patients assessed by observed analysis and 82.7% by modified non-responder imputation achieved PASI 75. Further, dose-dependent increases in PASI responses over time were noted, with higher efficacy at the 40 mg twice daily dosage.
In addition to PASI 75, the study also reported improvements in PASI 90 and PASI 100 endpoints, which represent 90% and 100% reductions in PASI scores, respectively. The safety profile remained favorable, with the most common treatment-emergent adverse events being upper respiratory tract infections, nasopharyngitis, and headaches.
Alumis's Chief Medical Officer, Dr. Jörn Drappa, expressed confidence in ESK-001's potential as a best-in-class oral treatment option based on the OLE results. The full 52-week OLE data is expected in the first half of 2025, and the Phase 3 ONWARD clinical program is ongoing.
The company also presented additional data supporting the efficacy and safety of the 40 mg twice daily dose of ESK-001. This includes biomarker data from the STRIDE trial and exposure-response analyses from clinical trials, which suggest that the 40 mg twice daily dose leads to the highest response rates.
ESK-001 is a highly selective allosteric tyrosine kinase 2 (TYK2) inhibitor, which is also being evaluated in a Phase 3 clinical program for systemic lupus erythematosus and other autoimmune indications. The Phase 3 trials for plaque psoriasis are designed to further evaluate the efficacy and safety of ESK-001 compared to placebo and apremilast.
This announcement is based on a press release statement from Alumis Inc. and reflects the ongoing efforts of the company to develop new treatments for immune-mediated diseases.
In other recent news, Alumis Inc. has initiated patient dosing in its ONWARD Phase 3 clinical program, focusing on the efficacy and safety of its drug candidate, ESK-001, for adults with moderate-to-severe plaque psoriasis. The program includes two 24-week global trials and a long-term extension trial. A modified release oral formulation of ESK-001 is also in development.
Alumis has received positive coverage from Cantor Fitzgerald and Morgan Stanley, both citing a promising immunology pipeline. Cantor Fitzgerald initiated coverage on Alumis with an Overweight rating, projecting potential revenues exceeding $1 billion from drug candidates ESK-001 and A-005. Morgan Stanley also initiated coverage with an Overweight rating, influenced by Alumis's robust therapeutic pipeline, including ESK-001 and A-005.
In addition, Alumis has secured $40 million through a private placement of common stock. This recent capital infusion is set to further the company's initiatives in the pharmaceutical preparations sector. These are among the latest developments for Alumis Inc.
InvestingPro Insights
While Alumis Inc. (NASDAQ:ALMS) is making strides in its clinical trials for ESK-001, investors should be aware of the company's financial position. According to InvestingPro data, Alumis has a market capitalization of $651.21 million, reflecting the market's current valuation of the company's potential.
InvestingPro Tips reveal that Alumis is quickly burning through cash, which is not uncommon for clinical-stage biopharmaceutical companies investing heavily in research and development. This cash burn rate is particularly relevant given the ongoing Phase 3 trials for ESK-001 in multiple indications.
Another InvestingPro Tip indicates that Alumis is not expected to be profitable this year, which aligns with the company's focus on clinical development rather than immediate commercialization. The operating income for the last twelve months stands at -$187.62 million, underscoring the significant investments being made in the company's pipeline.
Despite these financial challenges, Alumis holds more cash than debt on its balance sheet, providing some financial flexibility as it advances its clinical programs. This could be crucial for supporting the ongoing Phase 3 ONWARD clinical program and preparing for potential commercialization of ESK-001.
For investors seeking a more comprehensive financial analysis, InvestingPro offers additional tips and metrics that could provide deeper insights into Alumis's financial health and market position.
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