As the pandemic continues to challenge the market, Argus will discuss their forecast for 2022 on Tuesday, December 14th at 2 pm Eastern Time.
~ The initiation of the registration phase 3 ACTION clinical study of lixivaptan is an important milestone in bringing this potential new treatment option to ADPKD patients ~
~ In the ALERT study, all four subjects who previously discontinued JYNARQUE® due to hepatotoxicity were successfully titrated to the maintenance dose of risivatriptan; none of the subjects met the pre-specified discontinuation criteria; undoubtedly it appeared to be drug-induced liver injury ( DILI) case~
~ The publication of new patents will cover the use of lixivaptan in ADPKD until at least 2038 ~
Boston and London, December 14, 2021 (GLOBE NEWSWIRE) - Centessa Pharmaceuticals plc (the "Company") (NASDAQ: CNTA) and its subsidiary Palladio Biosciences, Inc. ("Palladio") today announced the start Actively recruit the key phase 3 clinical trial of the global ACTION study to evaluate lixivaptan as a potential treatment for autosomal dominant polycystic kidney disease (ADPKD). In addition, the company also reported the initial safety data of four participants in the ongoing open-label ALERT study of ADPKD subjects who had previously discontinued JYNARQUE® (tolvaptan) due to liver toxicity and announced a The license notice for a US patent application covers the use of lixivatriptan in ADPKD.
"Patients with ADPKD need alternative treatments to currently approved therapies, due to its side effects, which are related to the risk assessment and mitigation strategy (REMS) plan. To date, the pharmacodynamics and tolerability of lixivatriptan I am very encouraged by the data and look forward to seeing the benefits and safety data of the upcoming critical ACTION study," said Vicente Torres, Professor of Medicine and Professor of Medicine at the Mayo Clinic. The steering committee and principal investigator for action research.
"We are pleased to start registering for the ACTION study so that we can further evaluate the potential of lixivaptan as a new treatment option in the wider ADPKD patient population," said Saurabh Saha, MD, CEO of Centessa. "In addition, the initial safety data from the ALERT study of subjects who discontinued JYNARQUE due to hepatotoxicity continues to support the differentiated safety and tolerability characteristics of lixivaptan. In addition, it is mentioned in the recent licensing notice issued by the US Patent and Trademark Office The permitted claims should provide patent protection for the use of lixivaptan in the treatment of ADPKD in the United States until at least 2038."
"The initial safety data we shared from the ALERT study today is similar to our previous case study reported from the Mayo Clinic and provides additional evidence of the tolerability of lisivatriptan, especially if tova was taken before one group Among ADPKD subjects with abnormal liver chemistry at Putan," Palladio Chief Medical Officer Neil Shusterman, MD, said. "We look forward to bringing this potential new treatment option to patients with ADPKD."
Recruitment has begun for the global Phase 3 ACTION study, which includes a two-arm, double-blind, placebo-controlled, randomized phase (Part 1), and then a single-arm, open-label phase (Part 2). The study will assess the classification of MRI imaging in ADPKD and Mayo Clinic as 1C, 1D, or 1E and estimated glomerular filtration rate (eGFR) ≥25 and ≤90 mL/min/1.73 m2.
The main analysis of the ACTION study will be carried out at the end of the first part of the trial. The study will use 2:1 randomization (lixivaptan: placebo) to evaluate the effect of lixivaptan on reducing the decline in renal function, such as passing lixivaptan in 52 The difference in eGFR between Putan-treated and placebo-treated subjects was calculated in weeks. The final efficacy measurement at the end of the double-blind period will be performed when the subject discontinues the study drug during three consecutive clinical visits. The sample size of the study will be as many as 1,350 subjects, providing 90% power for the main analysis, and is designed to detect the 1.4 mL/min/1.73 m2 eGFR between lixivatriptan-treated and placebo-treated subjects. difference. Thirteen clinical sites have been launched, and the trial is expected to eventually recruit subjects at more than 200 sites in more than 20 countries. As previously disclosed, the company expects to administer the first subject in the ACTION study by the first quarter of 2022.
It is expected that all subjects who successfully completed Part 1 will continue to enter Part 2 of the study and will receive an additional 54-56 weeks of lixivaptan treatment to further assess the sustainability of the potential benefits of eGFR changes within two years. Consistent with Part 1, the updated efficacy measurement will be performed outside of the study drug. Both parts of the study will help to further determine the safety of lixivaptan. An independent data monitoring committee will periodically review all safety data, including liver chemistry data for all subjects throughout the study period. The company expects to complete the registration within 2 hours in 2023, and plans to submit a new drug application (NDA) after completing the one-year double-blind study (Part 1).
The company also reported preliminary safety data from the ongoing open-label ALERT study of ADPKD subjects who had previously stopped JYNARQUE® (tolvaptan) due to liver toxicity. The ALERT study aims to evaluate the liver and non-hepatic safety of subjects who previously had abnormal liver chemistry during tolvaptan treatment and met the criteria for possible drug-induced liver injury (DILI) and permanently discontinued the drug. Participants in the ALERT study were screened for up to 8 weeks, followed by a three-week baseline measurement period, followed by a three to six-week risivatriptan titration phase, with liver performed once a week during the baseline and titration phases Chemical test monitoring. During the maintenance phase, liver chemistry tests are performed every four weeks. The main outcome measure in the study was the proportion of subjects with alanine aminotransferase (ALT) levels> 3x ULN, which was determined to be related to lixivaptan, leading to the discontinuation of the study drug.
To date, 10 subjects have entered the screening, 5 have failed the screening, and 1 has failed the baseline measurement period. The four subjects who participated in the study developed DILI cases when receiving tolvaptan for ADPKD, the ALT elevation peaked between 1.8 times and 3.5 times ULN, and it was 23 to 140 days after tolvaptan was discontinued Revert to below ULN. Each of these subjects was successfully titrated to a maintenance dose of lixivaptan of 100 mg BID (one subject) or 200 mg BID (three subjects) and entered the maintenance phase of the study.
As of the most recent data cut-off date (December 3, 2021), three-quarters of the subjects are still using lixivaptan with a maximum treatment duration of 366 days, and the remaining subjects have treatment times of 174 days and 172 days, respectively sky. One subject successfully titrated to 200 mg of BID lixivaptan, but withdrew consent after 93 days of administration. No subjects had a clinically significant ALT elevation due to risivatriptan, and no subjects met the pre-specified stopping criteria for ALT levels> 3x ULN.
The ALERT study is still open to subjects who have confirmed DILI cases during tolvaptan treatment. Most subjects who discontinued tolvaptan treatment due to hepatotoxicity are also eligible to participate in the ACTION study, which is now the main focus of the company's recruitment efforts.
Lixivaptan Key U.S. Patent Application License Notice
On December 3, 2021, the United States Patent and Trademark Office issued a license notice for Palladio's patent application entitled "Lixivaptan formulations for the treatment of polycystic disease", which claimed to use lixivaptan's divided dose regimen to treat ADPKD. Before considering any applicable patent term extensions or adjustments, the expected patent term will expire on June 8, 2038.
About Centessa Pharmaceuticals Centessa Pharmaceuticals plc ("Centessa") aims to bring influential new drugs to patients by combining the advantages of an asset-centric model with the advantages of scale and diversification typical of large R&D organizations. The asset-centric model refers to a highly specialized, single-focused company led by a team of well-known subject matter experts. Centessa's asset-centric company's projects range from the discovery stage to late development, and include different therapeutic areas such as oncology, hematology, immunology/inflammation, neuroscience, hepatology, pulmonology, and nephrology. For more information, please visit www.centessa.com.
About Palladio Biosciences Palladio Biosciences, Inc. ("Palladio") was founded with the goal of developing translational drugs for the treatment of rare kidney diseases. Palladio is actively studying the potential of its main product candidate, lixivaptan, in patients with autosomal dominant polycystic kidney disease (ADPKD).
About Lixivaptan Lixivaptan is an investigational, oral, non-peptide selective vasopressin V2 receptor antagonist, which is under development for the potential treatment of ADPKD. The development plan aims to show that lixivaptan can slow down the decline in renal function commonly observed in ADPKD patients, while avoiding liver safety issues related to JYNARQUE®, a brand of tolvaptan suitable for ADPKD, which is currently the only one The approved drugs are used in ADPKD. Lixivaptan has received orphan drug designation from the FDA.
About the ACTION study The ACTION study is an ongoing two-arm phase 3 pivotal trial consisting of a double-blind, placebo-controlled, randomized phase (Part 1) and a single-arm open label phase (Part 2) to evaluate lixivium The effectiveness and safety of valaptan in ADPKD subjects.
In Part 1, all subjects will receive a placebo and all subjects will receive lixivaptan to determine the dose. As many as 1,350 subjects will be randomized to receive lixivatriptan or placebo at a 2:1 ratio. After 52 weeks of randomized treatment, the administration of the study drug will be suspended and the Part 1 final eGFR assessment will be obtained during the 3 follow-up visits that began during the 28-day period.
All subjects who completed Part 1 are expected to continue to Part 2 of the study and receive additional treatment with the active drug lixivaptan for 54-56 weeks. At the end of that period, the study drug will be discontinued and the final eGFR assessment in Part 2 will be obtained during 3 follow-up visits over a period of 28 days. For more information about the study, please visit the following link: https://clinicaltrials.gov/ct2/show/NCT04064346
About the ALERT study The ALERT study is an ongoing open-label, repeated dosing study that aims to evaluate the liver and non-liver of subjects who previously had abnormal liver chemistry during tolvaptan treatment and therefore permanently discontinued the drug Safety. After titration to the optimal dose, subjects will be enrolled and receive lixivaptan treatment for 52 weeks. For more information about the study, please visit the following link: https://clinicaltrials.gov/ct2/show/NCT04152837
About ADPKD ADPKD is a rare genetic disease characterized by the formation and enlargement of cysts in the kidneys, liver, and other organs. It is the fourth leading cause of kidney failure in the United States and one of the most common genetic diseases in humans. It has an equal incidence in women and men of all races in the world. There are an estimated 140,000 confirmed ADPKD patients in the U.S.
Forward-looking statements This press release contains forward-looking statements. These statements can be used such as "target", "expected", "believe", "probable", "estimated", "anticipated", "forecast", "target", "intended", "probable", "plan", " Possible", "potential", "seek", "will" and variations of these words or similar expressions designed to identify forward-looking statements. Any such statements in this press release that are not statements of historical facts can be considered forward-looking statements, including statements related to the company’s ability to provide patients with impactful drugs; our key executives promote the execution of the company’s project portfolio Capabilities; our asset-centric business model and its expected advantages and benefits; research and clinical development plans; the scope, progress, results and costs of developing our product candidates or any other future product candidates; our ongoing alerts and The design, scope and purpose of the action research; the development and therapeutic potential of our product candidates (including lixivaptan); strategy; regulatory matters, including the timing and likelihood of success for obtaining approval to initiate or continue clinical trials or sell any product; our The market size and opportunities of product candidates.
Any forward-looking statements in this press release are based solely on our current expectations, estimates and forecasts as of the date of this press release, and are subject to many risks and uncertainties, which may lead to actual results and assumptions. The determined results have a material adverse effect raised or implied in such forward-looking statements. These risks and uncertainties include, but are not limited to, risks related to our ability to protect and maintain intellectual property rights; business, regulatory, economic and competitive risks, uncertainties, contingencies and assumptions about the company; development of products and technologies The inherent risks of the company; the future results of our ongoing and planned clinical trials; our ability to obtain sufficient financing, including through our financing mechanism with Oberland, to fund our planned clinical trials and other expenses; industry trends; the industry The legal and regulatory framework, including obtaining and maintaining licenses to conduct or continue clinical trials; future expenditure risks associated with our asset-centric business model; any one or more of our product candidates will not be successfully developed and commercialized Risks; the results of preclinical studies or clinical studies cannot predict the risk of future results related to future research; and the risks associated with the COVID-19 pandemic, including the effects of Delta, Omicron, and any other variants. We describe these and other risks related to our plans and operations in more detail in our latest Form 10-Q filed by the SEC. We expressly disclaim any obligation to update any forward-looking statements, unless required by law.
Jennifer Porcelli, Head of Investor Relations
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