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Equillium, Inc. (NASDAQ:EQ), a biotechnology company with a market capitalization of $25.15 million and current stock price of $0.71, announced today the positive outcomes of their Phase 2 clinical trial for the treatment of moderate to severe ulcerative colitis (UC) with itolizumab.
According to InvestingPro data, the company maintains a strong balance sheet with more cash than debt, though it’s currently experiencing rapid cash burn. The study, which was co-sponsored with Biocon (NSE:BION) Limited, included a total of 90 biologic-naïve patients who were randomized to receive either itolizumab, a placebo, or adalimumab, an established biologic treatment, over a 12-week period.
The primary goal of the trial was to achieve clinical remission, defined by a Total (EPA:TTEF) Mayo Score of 2 or less with no individual sub-score above 1. Secondary endpoints were clinical response and endoscopic remission at 12 and 24 weeks, assessed by central endoscopy.
The results showed that 23.3% of patients in the itolizumab arm achieved clinical remission at week 12, compared to 20.0% in the adalimumab arm and 10.0% in the placebo group. Clinical response was noted in 63.3% of itolizumab patients versus 60.0% for adalimumab and 46.7% for placebo. Endoscopic remission rates were 16.7% for both itolizumab and adalimumab, against 6.7% for placebo.
The patient demographics showed a median age of 39 years, with a mean weight of 58 kilograms, and a balanced distribution of male and female participants across the study arms. Notably, the itolizumab arm had a higher baseline disease severity, with 23% of patients classified as severe, compared to none in the placebo and adalimumab arms. Additionally, 66% of the itolizumab group had left-sided colitis, against 30% and 43% in the other two arms, respectively.
Itolizumab was generally well-tolerated, with no safety concerns identified during the trial. These promising results may offer a new treatment option for UC patients, particularly those who have not previously been treated with biologics. While the company’s overall financial health score is rated as GOOD by InvestingPro, investors should note that analysts don’t expect profitability this year.
Equillium’s forward-looking statements suggest ongoing plans to develop itolizumab and a belief in the potential benefits of their product candidates. However, these statements also acknowledge the risks and uncertainties inherent in drug development, emphasizing that actual results may vary.
Analyst price targets range from $3 to $5, suggesting significant upside potential from current levels. For deeper insights into Equillium’s financial health and growth prospects, including additional ProTips and detailed metrics, consider subscribing to InvestingPro.
The information for this article is based on a press release statement.
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