HENDERSON, Nev. - Zura Bio Limited (NASDAQ:ZURA), an immunology-focused biopharmaceutical company, has recently submitted a Phase 2 study protocol to the U.S. Food and Drug Administration (FDA) for tibulizumab, a novel therapy aimed at treating systemic sclerosis (SSc), a rare autoimmune disease. The company announced the submission today, with the trial expected to begin in the fourth quarter of 2024.
The Phase 2 clinical trial is designed as a double-blind, placebo-controlled study to assess the safety, tolerability, and efficacy of tibulizumab in about 80 participants with early diffuse cutaneous systemic sclerosis (dcSSc). The study will also include an open-label extension and seeks to demonstrate improvements in both skin and lung symptoms, which are primary complications of SSc.
Tibulizumab is a humanized tetravalent bispecific dual antagonist antibody engineered to target IL-17A and BAFF, two molecules implicated in the pathogenesis of SSc. By neutralizing these pathways, tibulizumab could potentially address the immune dysregulation and fibrosis that are key drivers of the disease. The drug has not yet been approved by any regulatory authority, and its safety and efficacy for the treatment of SSc are still under investigation.
Systemic sclerosis affects approximately 300,000 people globally, with about 100,000 cases in the United States. The disease is characterized by chronic inflammation and fibrosis of connective tissues, affecting the skin, lungs, and other organs. Currently, treatment options for SSc are limited, with only two FDA-approved disease-modifying therapies for the severe lung complications associated with the disease.
Zura Bio's CEO, Robert Lisicki, expressed the company's commitment to advancing therapies that could potentially improve the quality of life for those affected by systemic sclerosis. The submission of the Phase 2 study protocol to the FDA represents a significant step forward in the development of tibulizumab.
The company is also preparing to initiate a Phase 2 clinical trial for tibulizumab in the treatment of hidradenitis suppurativa in the second quarter of 2025. Zura Bio is developing a portfolio of therapeutic indications for its assets, aiming to demonstrate their efficacy, safety, and convenience in treating autoimmune and inflammatory diseases.
This announcement is based on a press release statement from Zura Bio Limited. The company's forward-looking statements are predictions based on current expectations and are subject to risks and uncertainties that may cause actual results to differ materially. Investors are cautioned not to place undue reliance on these forward-looking statements.
In other recent news, Zura Bio Ltd. has been the subject of several analyst reports. Guggenheim maintained a Buy rating on the company with a steady price target of $15, following Zura Bio's third-quarter earnings release. The firm's analysis highlighted the progress of Zura Bio's clinical programs, especially tibulizumab for systemic sclerosis and plans for upcoming studies in hidradenitis suppurativa. Leerink Partners initiated coverage of Zura Bio with an Outperform rating and a $15 price target, while Piper Sandler reiterated an Overweight rating with a $26.00 price target, citing positive trial data for lusvertikimab, an investigational drug for treating moderate-to-severe ulcerative colitis.
Zura Bio recently reported robust first-quarter results for 2024, ending with a cash balance of $89.8 million following a successful funding round that raised about $112 million. The company also disclosed positive clinical trial results for lusvertikimab, reinforcing the bullish outlook of Piper Sandler on Zura Bio's stock.
In other company news, Zura Bio issued pre-funded warrants to shareholders who surrendered 4 million Class A ordinary shares back to the company at no cost; these shares were immediately canceled and retired. At the company's Annual General Meeting, all nine director nominees were re-elected to the board, and the reappointment of WithumSmith+Brown, PC as the independent registered public accounting firm was ratified. Furthermore, the company announced the departure of its Chief Scientific Officer, Michael Howell, stating that the separation was not due to any disputes regarding operational, financial, or reporting practices. These are the recent developments in Zura Bio Ltd.
InvestingPro Insights
As Zura Bio Limited (NASDAQ:ZURA) advances its clinical trials for tibulizumab, investors may find additional context from InvestingPro's financial metrics and tips. The company's market capitalization stands at $285.99 million, reflecting its current valuation as it progresses through these crucial development stages.
InvestingPro Tips highlight that Zura Bio holds more cash than debt on its balance sheet, which could be advantageous as it funds its upcoming clinical trials. This financial position is particularly relevant given the company's plans to initiate multiple Phase 2 studies in the near future. Additionally, the company's liquid assets exceed short-term obligations, potentially providing a buffer for research and development expenses.
However, it's important to note that Zura Bio is not currently profitable, with a negative P/E ratio of -6.89. This is not uncommon for biopharmaceutical companies in the development stage, as they often prioritize research and clinical trials over immediate profitability. The company's operating income for the last twelve months as of Q3 2023 was -$50.28 million, reflecting the substantial investments being made in its drug pipeline.
Despite these financial challenges, Zura Bio has shown a strong return over the last three months, with a price total return of 34.77%. This could indicate growing investor confidence in the company's clinical progress and potential market opportunities in treating rare diseases like systemic sclerosis.
For investors seeking a more comprehensive analysis, InvestingPro offers additional tips and metrics beyond those mentioned here. In fact, there are 6 more InvestingPro Tips available for Zura Bio, which could provide further insights into the company's financial health and market position as it moves forward with its clinical development programs.
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