BOSTON and LONDON - Centessa Pharmaceuticals plc (NASDAQ:CNTA) announced positive interim results from a Phase 1 trial for its drug candidate ORX750, showing significant improvements in wakefulness among sleep-deprived healthy volunteers. The trial tested the efficacy of ORX750, a selective orexin receptor 2 (OX2R) agonist, in restoring normative wakefulness as measured by the Maintenance of Wakefulness Test (MWT).
The study revealed that a 2.5 mg dose of ORX750 significantly increased mean sleep latency to 32 minutes compared to a placebo. This result suggests that the drug can restore a level of wakefulness considered normal. The trial also reported a favorable safety and tolerability profile for ORX750, with no frequent adverse events commonly associated with other OX2R agonists, such as visual disturbances or hepatotoxicity, observed as of the data cutoff date.
Based on these findings, Centessa plans to initiate Phase 2 studies of ORX750 targeting patients with narcolepsy type 1 (NT1), narcolepsy type 2 (NT2), and idiopathic hypersomnia (IH) in the fourth quarter of 2024. The Phase 1 trial, which is ongoing, has completed three single-ascending dose cohorts and two cohorts within a cross-over assessment of acutely sleep-deprived healthy volunteers.
The interim data also indicated a linear pharmacokinetic profile for ORX750 that supports once-daily oral dosing. The systemic exposure of the drug increased proportionally with the dose, and plasma concentrations peaked at two hours after administration.
The trial's results have been met with optimism by Centessa executives, who believe ORX750 demonstrates a potential best-in-class profile for treating sleep-wake disorders at low once-daily doses, coupled with a favorable safety and tolerability profile.
Centessa's orexin agonist program focuses on developing treatments for sleep-wake disorders by targeting the orexin system, which plays a crucial role in regulating the sleep-wake cycle. ORX750 has not yet been approved by the FDA or any other regulatory authority, and the company's statements regarding the drug's potential and development plans are forward-looking.
This article is based on a press release statement from Centessa Pharmaceuticals plc.
In other recent news, Centessa Pharmaceuticals has seen several notable developments. BMO Capital Markets has raised Centessa's stock price target from $15.00 to $20.00, maintaining an Outperform rating due to the company's potential in the narcolepsy treatment market. The company's ORX142 drug candidate shows promise in promoting wakefulness at low doses in non-human primates, according to recent preclinical studies.
In addition, both BMO Capital Markets and Oppenheimer have maintained an Outperform rating for Centessa, with the latter setting a $14.00 price target based on the potential of Centessa's ORX750 program in treating sleep disorders. Centessa has also made executive appointments, with John Crowley taking on the role of Chief Financial Officer and Gregory Weinhoff transitioning to Chief Business Officer.
The company has priced its public offering of American Depositary Shares at $9.25 each, aiming to raise approximately $100 million in gross proceeds. Lastly, the U.S. Food and Drug Administration has approved Centessa's Investigational New Drug application, allowing for Phase 1 clinical trials of ORX750. These recent developments highlight Centessa's ongoing efforts in the pharmaceutical industry.
InvestingPro Insights
As Centessa Pharmaceuticals plc (NASDAQ:CNTA) shares positive results from its Phase 1 trial of ORX750, the company's financial health and market performance provide additional context for investors. Notably, Centessa holds more cash than debt on its balance sheet, a reassuring sign of financial stability. This is complemented by analysts' expectations of sales growth in the current year, indicating potential upside from the company's drug development pipeline.
InvestingPro data shows that Centessa has a market capitalization of $1.69 billion with a high Price / Book multiple of 5.9, reflecting investor confidence in the company's assets relative to its share price. Despite not being profitable over the last twelve months, the company's gross profit margin stands at an impressive 100%, suggesting robust control over its cost of goods sold. Moreover, the stock has seen a significant return over the last year, with a 131.11% price total return, signaling strong investor enthusiasm.
For investors seeking more detailed analysis, there are additional InvestingPro Tips available for Centessa, including insights on earnings revisions and stock valuation metrics. These tips can be found at InvestingPro's dedicated page for Centessa (https://www.investing.com/pro/CNTA).
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