5-HT4 receptor

Data Reported by Can-Fite Veterinary Partner Vetbiolix who already exercised its option for a full license deal worth $325M Ramat Gan, Israel, Oct. 18, 2024 (GLOBE NEWSWIRE) -- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, today announced that its veterinary partner Vetbiolix reported positive final results from the osteoarthritis multicenter clinical study in dogs treated with Piclidenoson. Vetbiolix, Can-Fite’s veterinary commercialization partner, which is covering all costs associated with veterinary clinical development, successfully concluded the full study. Vetbiolix already exercised its option to enter into a full in-license agreement with Can-Fite and is obligated to pay Can-Fite an upfront payment, milestone payments and royalties on sales upon regulatory approval, summing up to projected income of $325M to Can-Fite over the next 10 years. The study looked at the effect of 90 days treatment with Piclidenoson at 100 μg/kg and 500 μg/kg twice daily orally in dog patients with osteoarthritis. Including all evaluable patients, the primary objective was the Liverpool OsteoArthritis in Dogs (LOAD) questionnaire for the assessment of symptoms severity evaluated on dog’s mobility. The secondary objectives included Visual Analog Scale (VAS) for pain assessment by pet parents and Numerical Rating Score (NRS) for (i) lameness and (ii) pain assessment by the veterinarian. The study reached the primary and secondary endpoints with a dose and time dependent inhibitory effect of Piclidenoson on LOAD and VAS, together with a favorable trend on NRS scores, demonstrating significant improvement in clinical status and decrease in pain utilizing the 500 µg/kg dose. The canine osteoarthritis market is projected to reach $3 billion by 2028. There is a clear need in the market for a safe and effective canine osteoarthritis drug. Current treatments for canine osteoarthritis include oral non-steroidal anti-inflammatory drugs (NSAIDs), which only treat symptoms and carry significant harmful side effects, and an injectable disease-modifying osteoarthritis drug (DMOAD) that targets the progression of the disease. “The final data from the osteoarthritis study are very encouraging and this veterinary indication offers Can-Fite the opportunity to get Piclidenoson onto the market faster to benefit canine, and potentially contribute to near-term revenues. We are very pleased to work productively with the team at Vetbiolix.” stated Can-Fite VP of business Development Dr. Sari Fishman. About Piclidenoson Piclidenoson is a novel, first-in-class, A3 adenosine receptor agonist (A3AR) small molecule, orally bioavailable drug with an excellent safety and efficacy profile demonstrated in a Phase III clinical study in psoriasis. The drug’s mechanism of action entails inhibition of the inflammatory cytokines interleukin 17 and 23 (IL-17 and IL-23) and the induction of apoptosis of patients’ skin cell keratinocytes involved with the disease pathogenicity. About Can-Fite BioPharma Ltd. Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF) is an advanced clinical stage drug development Company with a platform technology that is designed to address multi-billion dollar markets in the treatment of cancer, liver, and inflammatory disease. The Company’s lead drug candidate, Piclidenoson recently reported topline results in a Phase III trial for psoriasis. Can-Fite’s liver drug, Namodenoson, is being evaluated in a Phase IIb trial for the treatment of NASH a Phase III trial for hepatocellular carcinoma (HCC), and the Company is planning a Phase IIa study in pancreatic cancer. Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the U.S. Food and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. CF602, the Company’s third drug candidate, has shown efficacy in the treatment of erectile dysfunction. These drugs have an excellent safety profile with experience in over 1,600 patients in clinical studies to date. For more information please visit: www.canfite.com. About VETBIOLIX SAS VETBIOLIX develops innovative products for the treatment and prevention of diseases affecting pets. VETBIOLIX has built a unique pipeline of First-in-class oral small molecules in-licensed (exclusive and worldwide license) from Human Biotech worldwide which will answer to veterinary unmet medical needs in periodontitis (VBX-1000; Cathepsin-K inhibitor), osteoarthritis (VBX-2000; Adenosin-A3 agonist) and gut motility disorders (VBX-3000; 5-HT4 agonist). VETBIOLIX focuses exclusively on clinical developments of its drug candidates: the company invests on (i) clinical proof of concept studies, (ii) CMC-Pharmaceutical developments, (iii) regulatory Pilot clinical studies and (iv) regulatory Pivotal clinical studies. Revenue generation of the company will be based on out-licensing and/or co-developments deals with the Veterinary Pharmaceutical Industry. For more information please visit: https://www.vetbiolix.com Contact: matthieu.dubruque@vetbiolix.com Forward-Looking StatementsThis press release may contain forward-looking statements, about Can-Fite’s expectations, beliefs or intentions regarding, among other things, its product development efforts, business, financial condition, results of operations, strategies or prospects. All statements in this communication, other than those relating to historical facts, are “forward looking statements”. Forward-looking statements can be identified by the use of forward-looking words such as “believe,” “expect,” “intend,” “plan,” “may,” “should” or “anticipate” or their negatives or other variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical or current matters. Forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to known and unknown risks, uncertainties and other factors that may cause Can-Fite’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause actual results, performance or achievements to differ materially from those anticipated in these forward-looking statements include, among other things, our history of losses and needs for additional capital to fund our operations and our inability to obtain additional capital on acceptable terms, or at all; uncertainties of cash flows and inability to meet working capital needs; the initiation, timing, progress and results of our preclinical studies, clinical trials and other product candidate development efforts; our ability to advance our product candidates into clinical trials or to successfully complete our preclinical studies or clinical trials; our receipt of regulatory approvals for our product candidates, and the timing of other regulatory filings and approvals; the clinical development, commercialization and market acceptance of our product candidates; our ability to establish and maintain strategic partnerships and other corporate collaborations; the implementation of our business model and strategic plans for our business and product candidates; the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and our ability to operate our business without infringing the intellectual property rights of others; competitive companies, technologies and our industry; risks related to any resurgence of the COVID-19 pandemic and the war between Israel and Hamas; risks related to not satisfying the continued listing requirements of NYSE American; and statements as to the impact of the political and security situation in Israel on our business. More information on these risks, uncertainties and other factors is included from time to time in the “Risk Factors” section of Can-Fite’s Annual Report on Form 20-F filed with the SEC on March 28, 2024 and other public reports filed with the SEC and in its periodic filings with the TASE. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Can-Fite undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws. Contact Can-Fite BioPharmaMotti Farbsteininfo@canfite.com+972-3-9241114

MONDAY, Sept. 23, 2024 -- Antidepressants have the potential to improve memory and thinking skills, a new study suggests. Some patients experienced a boost on brain tests after taking the SSRI antidepressant escitalopram (Lexapro), researchers report. The drug appeared to affect a serotonin receptor in the brain called the 5HT4 receptor, according to results published recently in the journal Biological Psychiatry . Serotonin is described as a “feel good” hormone, researchers said in background notes. Higher levels of serotonin in the brain contribute to a sense of well-being and have been shown to ease clinical depression. “It seems that the SSRI medication contributes to an improvement on cognitive function, at the same time as helping improve mood,” said lead investigator Vibeke Dam , a senior researcher in neurology and neurobiology with Copenhagen University Hospital in Denmark. “Our work ties the improvement in cognitive function to the specific 5HT4 receptor and suggest that direct serotonin 4 receptor stimulation may be an important pro-cognitive target to consider in optimizing outcomes of antidepressant treatment,” Dam added in a journal news release. “It also reinforces the idea that serotonin is crucial to mood improvement." For the study, researchers scanned the brains of 90 depressed patients to measure 5HT4 receptor function in their brains. The patients also were tested for mood problems and cognitive abilities. Then the patients were given daily escitalopram (Lexapro) for eight weeks. At the end of the study, 40 patients were rescanned and retested. What did they find? The patients’ performance on cognitive tests had improved -- particularly their ability to recall words -- and this performance appeared to be linked to higher activity with the 5HT4 receptor. “This work points to the possibility of stimulating this specific receptor so that we can treat cognitive problems, even aside from whether or not the patient has overcome the core symptoms of depression,” said lead researcher Dr. Vibe Froekjaer , a clinical professor of neuropsychiatry with Copenhagen University Hospital in Denmark. The team’s next step will be to treat patients with drugs that specifically target the 5HT4 receptor, and then assess the effect on their brain function. Serotonin is found in the gut, and there are irritable bowel syndrome drugs that specifically bind to and stimulate 5HT4 receptors, researchers said. Researchers also presented these findings Monday at the European College of Neuropsychopharmacology’s annual meeting in Milan. The study “demonstrates the intimate role of brain 5HT4 receptors in cognitive function,” said Philip Cowen , a professor of psychopharmacology with the University of Oxford. “This confirms recent work from Oxford showing that the 5HT4 receptor stimulant, prucalopride -- a drug licensed for the treatment of constipation -- improves memory in both healthy participants and people at risk of depression,” said Cowen, who was not involved in the study. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Entero Therapeutics to integrate applications in planned Phase 3 study of latiglutenase for celiac disease and explore additional uses of technology in clinical trial complianceBOCA RATON, Fla., Sept. 10, 2024 (GLOBE NEWSWIRE) -- Entero Therapeutics, Inc., (NASDAQ: ENTO), (“Entero Therapeutics” or the “Company”), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today announced its entry into a binding letter of intent (the “Letter of Intent”) with Data Vault Holdings, Inc. (“Data Vault”), a privately held technology holding company, to exclusively license two technology product suites owned by Data Vault -- QOLPOM® and FotoDigm® (the “Proposed Transaction”). Entero Therapeutics will work with Data Vault before and after the closing of the Proposed Transaction to secure funding for the customization of this clinical trial compliance software that includes a focus on the use of DigitalTwins and high-performance computing. In parallel, Entero Therapeutics plans to develop applications for its own near-term use with gastrointestinal (GI) clinical trials beginning with the planned Phase 3 trial for latiglutenase for the treatment of celiac disease. Under the terms of the Letter of Intent, Entero Therapeutics, upon execution of a definitive agreement, would receive an exclusive, global license to pilot the technology platform in Entero Therapeutics’ clinical trials, and to develop and commercialize Data Vault’s QOLPOM® and FotoDigm® patented pharmaceutical regime compliance software for use in clinical trials with third-parties in the pharma and biotech sectors. In consideration, Entero Therapeutics will issue to Data Vault shares of the Company’s convertible preferred stock priced at a premium to the market and single digit revenue sharing royalties on net sales. The Proposed Transaction is expected to close by the end of September, and the entry into definitive documentation will be conditioned upon fulfillment requirements of no less than $500K of strategic investment into Entero Therapeutics (the “Strategic Investment”), with a target of ultimately securing up to $3 million of further strategic investment with Data Vault’s assistance. The terms of the Proposed Transaction provide for Data Vault to support the Company’s pursuit of the Strategic Investment. The Strategic Investment would provide Entero Therapeutics with access to both capital and technology for a pilot program and the initiation and potential improvement of the Company’s future clinical trials. James Sapirstein, Chairman and CEO of Entero Therapeutics, added, “We are very pleased to have the opportunity to secure an exclusive, worldwide license from Data Vault for its clinical trial compliance technology platform. Compliance is a major issue in drug development – it directly impacts the time, cost and success of clinical trials. We believe that the software platform has the potential to improve outcomes for our Phase 3 latiglutenase trial in celiac disease, along with the other GI therapeutic indications that we are planning to pursue. Both companies are committed to working together to customize the software for the latiglutenase trial. Our clinical trials would be the testing ground for these products and we believe that if they are validated in the clinic, they will have much broader commercial applications for other pharma companies across multiple disease indications.” Mr. Sapirstein added, “We are very impressed with the potential of Data Vault’s IP portfolio – some of which has been historically validated across multiple sectors and most recently in the Data Vault-WisA Technologies transaction, where other Data Vault IP not included in the Proposed Transaction was acquired. FotoDigm IP that was recently issued has a broad scope and has been cited by major IT and healthcare players as references. We are confident that the two assets have the potential to advance the state of the art in clinical trial monitoring and compliance and could create a commercial opportunity with pharma and biotech companies in the industry.” The Company’s use of the compliance platform would enable Entero Therapeutics to demonstrate the potential effectiveness and commercial scalability for incorporation in new software applications for a wide range of clinical-trial compliance across multiple therapeutic indications. Under the terms of the Letter of Intent, Entero Therapeutics would assume responsibility for all future clinical trial and commercial development in this sector and would be exclusively authorized to out-license to third parties within. The potential licensing agreement would include an activation triggered upon a capital infusion through strategic investment in Entero Therapeutics, and access to capital, technology and out-licensing within the biopharmaceutical field. The solution has been designed to assist with Entero Therapeutics’ completion of its medical trials in the present and future. The Letter of Intent also provides for a right of first refusal for Entero Therapeutics to fully-acquire the QOLPOM® and FotoDigm® assets from Data Vault Holdings, subject to certain conditions as set forth in the Letter of Intent. QOLPOM® and FotoDigm® were developed by the late and Honorable Arizona State Senator David Bradley, a behavioral healthcare administrator and the father of Data Vault Holdings’ Chief Executive Officer. QOLPOM® (Quality of Life and Peace of Mind) was developed to solve critical behavioral problems within the remote patient monitoring space leveraging machine learning and IoT sensory capabilities. FotoDigm® is a patented machine vision technology (U.S. patent number 11,437,139 Method and Apparatus for Biometric Data Collection Combing Visual Data with Historical Health Records Metadata) and has been cited by AT&T, Medtronic, Indiana University and Express Scripts amongst others. A second patent (U.S. patent number 12,040,088 issued on Jul 16, 2024) includes foundational and expanded claims and a platform designed to reduce the costs and streamline processes of data collection, verification on a highly scalable and replicable technology for clinical trial data management. The terms of the Proposed Transaction are subject to a number of contingencies, including the completion of customary due diligence and the negotiation and execution of definitive agreements. Upon execution of the definitive agreement, the completion of the transaction will be subject to, among other pre-closing requirements, satisfaction of the conditions negotiated therein, receipt of the Strategic Investment on terms satisfactory to Entero Therapeutics, and receipt of all third-party (including governmental) approvals, licenses, consents, and clearances, as and when applicable. There can be no assurance that the Proposed Transaction will be completed on the terms contemplated in the Letter of Intent or otherwise. About Entero Therapeutics, Inc.Entero Therapeutics is a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases. The Company currently has a therapeutic development pipeline with multiple late-stage clinical programs built around three proprietary technologies: latiglutenase, a Phase 3-ready, potentially first-in-class, targeted, oral biotherapeutic for celiac disease; capeserod, a selective 5-HT4 receptor partial agonist being developed for gastroparesis; and adrulipase, a recombinant lipase enzyme designed to enable the digestion of fats and other nutrients in cystic fibrosis and chronic pancreatitis patients with exocrine pancreatic insufficiency. Entero Therapeutics is headquartered in Boca Raton, Florida. For more information visit www.enterothera.com. About Data Vault Holdings Inc.Data Vault Holdings thrives by strategically managing a diverse portfolio that includes a robust patent network and innovative ventures. Data Vault Holdings’ success stems from Data Vault Holdings’ ability to bridge intellectual property protection with market opportunities, driving transformative innovations across sectors. By fostering a culture of creativity and collaboration, Data Vault Holdings continuously redefines industry standards and propel forward-thinking solutions that resonate globally. Through Data Vault Holdings’ integrated approach, Data Vault Holdings remains at the forefront of driving impactful advancements and shaping the future of innovation. WisA Technologies recently announced the execution of a definitive asset purchase agreement for the purchase of Data Vault Holdings’ information technology intellectual property for its spatial audio technology business for $210 million dollars. For more information visit: www.datavaultholdings.com. About Honorable Senator David BradleyThe former Senator died of pancreatic cancer that did as it often does, eluded early detection, a disease that can exhibit aggressive growth that makes it one of the more life-threatening of GI cancers. To learn more about David Bradley visit www.senatorbradley.com. Forward-Looking StatementsThis press release of and by the Company may contain certain statements relating to future results which are forward-looking statements. It is possible that the Company’s actual results and financial condition may differ, possibly materially, from the anticipated results and financial condition indicated in these forward-looking statements, depending on factors including whether a definitive agreement for the Proposed Transaction will be entered into; whether the Proposed Transaction, or any other contemplated transaction, may be completed with different terms, in an untimely manner, or not at all; whether the Company will be able to realize the benefits of the Proposed Transaction described herein; the Company’s current and future capital requirements and its ability to raise additional funds to satisfy its capital needs; whether there are delays in the engagement of a new independent registered public accounting firm; whether there are any further delays in the preparation and filing of the Company’s Form 10-Q; whether the Company will be able to realize the expected benefits of its acquisition of ImmunogenX; the Company’s ability to integrate the assets and contemplated commercial operations acquired from ImmunogenX into the Company’s business; whether the Company will be able to effectively and timely service its debt; whether results obtained in preclinical and nonclinical studies and clinical trials will be indicative of results obtained in future clinical trials; whether preliminary or interim results from a clinical trial will be indicative of the final results of the trial; whether the Company will be able to maintain compliance with Nasdaq’s continued listing criteria and the effect of a delisting from Nasdaq on the market for the Company’s securities; whether the Company will be able to satisfy the terms of any plan of compliance it submits to Nasdaq; whether Nasdaq will accept any plan of compliance the Company submits, or provide any other accommodations to the Company; the size of the potential markets for the Company’s drug candidates and its ability to service those markets; and the effects of the First Wave Bio, Inc. acquisition, the related settlement and their effect on the Company’s business, operating results and financial prospects. Additional information concerning the Company and its business, including a discussion of factors that could materially affect the Company’s financial results are contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, under the heading “Risk Factors,” as well as the Company’s subsequent filings with the Securities and Exchange Commission. All forward-looking statements included in this press release are made only as of the date of this press release, and we do not undertake any obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware. For more information:Entero Therapeutics, Inc.777 Yamato Road, Suite 502Boca Raton, FL 33431Phone: (561) 589-7020info@enterothera.com Media contact:Russo PartnersDavid Schull(347) 956-7697 This press release was published by a CLEAR® Verified individual.