TEL AVIV, Israel & PARSIPPANY, N.J. - Teva Pharmaceutical Industries (NYSE:TEVA) Ltd. (NYSE and TASE: TEVA) has revealed encouraging safety and pharmacokinetic data from its first-in-human trials of the investigational drug anti-TL1A (TEV-™574). The drug, a human monoclonal antibody, targets TL1A, a factor involved in immune system response, and has potential uses in treating inflammatory bowel diseases (IBD), including ulcerative colitis (UC) and Crohn's disease (CD).
According to the data, anti-TL1A (TEV-™574) demonstrated rapid and sustained suppression of free TL1A, indicating effective target engagement. It also showed a favorable safety profile and was well-tolerated in patients with asthma, which supports the continuation of clinical trials for moderate-to-severe IBD. These findings are set to be presented at the European Crohn's and Colitis Organisation (ECCO) Congress in Stockholm, Sweden.
Dr. Eric Hughes, Teva's Executive Vice President of Global R&D and Chief Medical Officer, stated that the results align with extensive pre-clinical evidence and support ongoing clinical investigations. Teva is currently conducting the RELIEVE UCCD Phase 2 trial, which utilizes a basket study design to include patients with either UC or CD.
The Phase 1 study in healthy volunteers and patients with mild asthma, along with a Phase 2 study in patients with severe asthma, showed dose-proportional increases in drug exposure and minimal accumulation after multiple doses every two weeks. Furthermore, a prolonged decrease in free TL1A levels was observed, lasting up to two months after the last dose.
On November 30, 2023, Teva and Sanofi (EPA:SASY) (NASDAQ:SNY) (EURONEXT: SAN and NASDAQ: SNY) announced a collaboration deal to co-develop and co-commercialize anti-TL1A (TEV-˜574) for the treatment of UC and CD. Under the agreement, Teva received an upfront payment of $500 million and is eligible for up to $1 billion in development and launch milestones, with shared development costs and profits between the companies.
Inflammatory bowel diseases, which include CD and UC, affect millions worldwide and are characterized by chronic inflammation of the gastrointestinal tract. The RELIEVE UCCD trial is a 14-week study evaluating the efficacy, safety, and tolerability of anti-TL1A (TEV-™574) in adults with UC or CD, with an option for participants to enter a long-term extension phase.
This report is based on a press release statement.
InvestingPro Insights
In light of Teva Pharmaceutical Industries Ltd.'s (NYSE and TASE: TEVA) recent advancements in its clinical trials, investors are closely monitoring the company's performance metrics. According to real-time data from InvestingPro, Teva boasts a substantial market capitalization of 14.94B USD, reflecting its significant presence in the pharmaceutical industry. While the company has faced challenges with profitability, as indicated by a negative P/E ratio of -26.62 for the last twelve months as of Q4 2023, analysts are optimistic about Teva's future. They predict the company will be profitable this year, which is corroborated by a more favorable forward P/E ratio of 9.49.
InvestingPro Tips highlight that Teva has a high shareholder yield and net income is expected to grow this year. These insights are particularly relevant as the company progresses with its anti-TL1A (TEV-™574) drug trials, potentially boosting investor confidence. Moreover, 3 analysts have revised their earnings upwards for the upcoming period, signaling positive sentiment around Teva's financial prospects.
Investors may also find encouragement in Teva's recent stock performance. The company has seen a strong return over the last month, with a 16.46% price total return, and an even more impressive 37.78% over the last three months. This momentum may reflect market optimism about Teva's strategic moves, including the collaboration deal with Sanofi and the potential of its investigational drug to treat IBD.
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