SOUTH SAN FRANCISCO - Alumis Inc. (NASDAQ:ALMS), a biopharmaceutical company, has initiated patient dosing in its ONWARD Phase 3 clinical program, aiming to evaluate the efficacy and safety of its drug candidate, ESK-001, for adults with moderate-to-severe plaque psoriasis. This announcement follows positive results from the Phase 2 STRIDE clinical trial and ongoing open-label extension study.
The ONWARD Phase 3 program includes two 24-week global trials, ONWARD1 and ONWARD2, and an additional long-term extension trial, ONWARD3, to assess the durability and long-term safety of the response. The trials will compare ESK-001 with placebo and apremilast, a current oral psoriasis medication, across approximately 840 patients.
ESK-001 is a selective allosteric tyrosine kinase 2 (TYK2) inhibitor, which has shown promise in Phase 2 trials, where it was generally well tolerated and demonstrated significant therapeutic effects. The upcoming Phase 3 trials will further investigate these findings, with co-primary efficacy endpoints focused on the proportion of patients achieving a reduction in Psoriasis Area and Severity Index (PASI 75) and static Physician's Global Assessment (sPGA) score of 0/1 compared to placebo at Week 16.
The company is also working on a once-daily modified release oral formulation of ESK-001 to potentially replace the current immediate release version that requires twice-daily dosing. Additionally, Alumis is exploring the drug's application in other autoimmune indications beyond plaque psoriasis, such as systemic lupus erythematosus.
Psoriasis, a chronic autoimmune condition, manifests as red, scaly skin patches that can significantly impact the quality of life, especially in moderate-to-severe cases. Alumis believes that ESK-001 could potentially meet the unmet need for an effective oral treatment that balances efficacy with safety.
While topline data from the Phase 3 trials are anticipated in 2026, interim updates from the ongoing studies are expected in the second half of 2024 and 2025.
In other recent news, Alumis Inc has been the subject of optimistic coverage from both Cantor Fitzgerald and Morgan Stanley, with both firms citing a promising immunology pipeline. Cantor Fitzgerald initiated coverage on Alumis with an Overweight rating, highlighting the company's potential with small molecule drug candidates such as ESK-001 and A-005.
The firm projects that these drug candidates have the potential to generate revenues exceeding $1 billion, a significant leap considering Alumis's current enterprise value of approximately $200 million.
ESK-001, a TYK2 inhibitor for psoriasis, is advancing into Phase 3 trials, while A-005, a brain penetrant TYK2 inhibitor, is in Phase 1 trials. Alumis's focus on immunology treatments is timely, given the expansive market for such therapies, and the progression of these drug candidates could potentially bring new treatment options to a sizable patient population.
Similarly, Morgan Stanley initiated coverage on Alumis stock with an Overweight rating, influenced by Alumis's robust therapeutic pipeline. The company is developing two oral therapies, ESK-001 and A-005, both of which are undergoing clinical trials.
InvestingPro Insights
As Alumis Inc. (NASDAQ:ALMS) progresses with its ONWARD Phase 3 clinical program for ESK-001, the company's financial health and market performance are critical to its ability to sustain long-term research and development. According to recent InvestingPro data, Alumis holds a market capitalization of $679.31 million USD, reflecting the market's current valuation of the company.
InvestingPro Tips suggest that while Alumis holds more cash than debt, indicating a solid liquidity position, the company is quickly burning through cash, which could impact its operations if not managed effectively. Furthermore, the company's stock appears to be in overbought territory according to the Relative Strength Index (RSI), which may suggest a potential reevaluation by investors in the near term. With analysts not anticipating profitability this year and expecting a drop in net income, these financial metrics are essential for investors to monitor as Alumis advances its clinical trials.
Additional metrics of note include a negative Price/Earnings (P/E) ratio of -0.78 and an adjusted P/E ratio for the last twelve months as of Q1 2024 at -4.02, underlining the company's current lack of profitability. Moreover, the company's operating income is reported at a loss of $169.11 million USD for the same period.
For investors seeking to delve deeper into Alumis' financials and future prospects, InvestingPro offers a range of additional tips. Currently, there are 9 more InvestingPro Tips available, which can be accessed at https://www.investing.com/pro/ALMS. To enhance your investing strategy, use the coupon code PRONEWS24 to get up to 10% off a yearly Pro and a yearly or biyearly Pro+ subscription.
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