Sequana Medical announces positive results from CHIHUAHUA, Phase 1 clinical trial of second-generation DSR product for congestive heart failure
- Phase 1 clinical trial (CHIHUAHUA) demonstrates that single dose of second-generation DSR product (DSR 2.0) is safe andwell-tolerated, and indicates a compelling dosing profile
- On track to file INDiapplicationto US FDA in Q1 2023
- Start ofMOJAVE, a US multi-center randomized controlled Phase 1/2a clinical trial of DSR 2.0,planned forQ2 2023
Ghent, Belgium – 01 March2023– Sequana Medical NV (Euronext Brussels: SEQUA) (the "Company" or "SequanaMedical"), a pioneer in the treatment of fluid overload in liver disease, heart failure and cancer, today announces positive results from its Phase 1 single-center, single-arm, single-dose trial (CHIHUAHUA) with its second-generation DSR product (DSR 2.0).
This Phase 1 trial was conducted in ten stable peritoneal dialysis patients, who received a single treatment of Sequana Medical’s proprietary DSR 2.0 product, administered via their pre-existing peritoneal dialysis catheter, over a 24-hour dwell period. The purpose of the trial was to evaluate the safety and tolerability profile of DSR 2.0, as well as to understand the dosing dynamics of DSR 2.0.
DSR 2.0 was generally safe and well-tolerated, with no serious adverse events or discontinuations due to adverse events. No patient showed a clinically relevant change in serum sodium levels or progressive hyponatremia, a further proof of safety of DSR 2.0. On average, a total of approximately 3L of fluid was removed per patient including 9g of sodium following a single treatment with 0.5L DSR 2.0 and a 24-hour dwell period.
Oliver Gödje, Chief Medical Officer of Sequana Medical, commented: “The results of this study are really encouraging and, together with the positive safety data from the GLPii studies reported earlier this month, enablethe filing ofour IND application with the US FDA for MOJAVE, our US randomized controlled Phase 1/2a clinical trial, planned to start in Q2 2023.
“In addition to positive safetyand tolerability findings, with no serious adverse events or discontinuations, the amount of fluid and sodium removed following a single treatment is an indication of the effectiveness of DSR 2.0 as a potential treatment for patients with congestive heart failure.”
On track to start MOJAVE with DSR 2.0 in Q2 2023
The Company is progressing the development of its proprietary DSR 2.0 product, a sodium-free dextrose / icodextrin solution that is expected to have an improved therapeutic and favourable safety profile, and robust intellectual property protection. Data from the GLP animal studiesiii and Phase 1 CHIHUAHUA study are intended to support the filing of the US IND application, planned for Q1 2023.
Following several initial discussions with the FDA, MOJAVE, a US multi-center randomized controlled Phase 1/2a clinical trial of DSR 2.0, is on track to start in Q2 2023, assuming FDA approval of the IND application. The intention is to enrol 30 diuretic-resistant chronic heart failure patients with persistent congestion. Of these, 20 randomized patients will receive DSR 2.0 administered via a peritoneal catheter on top of usual care for congestive heart failure (CHF) for up to four weeks and ten randomized patients will receive intravenous loop diuretic treatment as part of maximized usual care for CHF alone. Following four weeks of treatment, there will be a three-month safety follow-up period. Prior to enrolment of these 30 patients, the intention is for three additional patients to be enrolled in a non-randomized safety cohort and to receive DSR 2.0 administered via a peritoneal catheter on top of CHF usual care for up to four weeks. Progression to the enrolment of the 30 randomized patients is anticipated to be dependent upon DSMBiv approval following their review of the initial three patients. More details on the final trial design will be announced following the FDA approval of the US IND application. Interim data of MOJAVE are expected in H2 2023 followed by top-line results in H2 2024.
For more information, please contact:
Director Investor Relations
T: +32 (0)498 053579
Optimum Strategic Communications
Nick Bastin, Jonathan Edwards, Vici Rabbetts
T: +44 (0) 208 078 4357
About fluid overload in heart failure (AKA congestion)
Heart failure is the leading cause of US hospitalizations in patients over 65 years old and 90% of these admissions are due to fluid overload, which is recognized as the primary driver of morbidity and hospitalization. Standard of care includes treatment with diuretic drugs, but these have well-recognized toxicity and resistance issues. Half of the heart failure patients admitted for fluid overload are discharged with no clinically relevant loss of fluid and one in four is re-admitted to the hospital within 30 days of discharge. It is estimated that 200,000 US heart failure patients have drug-resistant congestion requiring repeated hospitalization, severely impacting their survival and quality of life and creating a heavy financial burden.
About Sequana Medical
Sequana Medical NV is a pioneer in treating fluid overload, a serious and frequent clinical complication in patients with liver disease, heart failure and cancer. These patients can have up to 15 liters of extra fluid in their bodies, causing major medical issues including increased mortality, repeated hospitalizations, severe pain, difficult breathing and restricted mobility that severely impacts daily life. Although diuretics are standard of care, the problem is that in many patients they are no longer effective and / or tolerable. There are limited effective treatment options for these patients, resulting in poor clinical outcomes, high costs and a major impact on their quality of life. Sequana Medical is seeking to provide innovative treatment options for this large and growing “diuretic-resistant” patient population.
alfapump® and DSR® are Sequana Medical's proprietary platforms that work with the body to treat diuretic-resistant fluid overload, delivering major clinical and quality of life benefits for patients and reducing costs for healthcare systems. The Company has reported positive primary endpoint data from the North American pivotal POSEIDON trial of the alfapump in recurrent or refractory ascites due to liver cirrhosis, enabling the filing of a Pre-Market Approval (PMA) application with the FDA, planned for H2 2023. Having delivered clinical proof-of-concept for DSR as a disease-modifying drug program for the treatment of heart failure, the Company is planning to commence MOJAVE, a US multi-centered randomized controlled Phase 1/2a clinical trial of DSR 2.0, in Q2 2023.
Sequana Medical is listed on Euronext Brussels (Ticker: SEQUA.BR) and headquartered in Ghent, Belgium. For further information, please visit www.sequanamedical.com.
Important Regulatory Disclaimers
The alfapump® system is currently not approved in the United States or Canada. In the United States and Canada, the alfapump system is currently under clinical investigation (POSEIDON Trial) and is being studied in adult patients with refractory or recurrent ascites due to cirrhosis. For more information regarding the POSEIDON clinical trial see www.poseidonstudy.com. DSR® therapy is still in development and it should be noted that any statements regarding safety and efficacy arise from ongoing pre-clinical and clinical investigations which have yet to be completed. DSR therapy is currently not approved for clinical research in the United States or Canada. There is no link between DSR therapy and ongoing investigations with the alfapump system in Europe, the United States or Canada.
Note: alfapump® is a registered trademark. DSR® is a registered trademark in the Benelux, China, the EU, United Kingdom, and Hong Kong.
This press release may contain predictions, estimates or other information that might be considered forward-looking statements. Such forward-looking statements are not guarantees of future performance. These forward-looking statements represent the current judgment of Sequana Medical on what the future holds, and are subject to risks and uncertainties that could cause actual results to differ materially. Sequana Medical expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release, except if specifically required to do so by law or regulation. You should not place undue reliance on forward-looking statements, which reflect the opinions of Sequana Medical only as of the date of this press release.
i IND: Investigational New Drug
ii GLP: Good Laboratory Practices
iii Data reported in press release of 8 February 2023
iv DSMB: Data and Safety Monitoring Board
- Press release_CHIHUAHUA data DSR 2.0_1 March 2023_NL_vF
- Press release_CHIHUAHUA data DSR 2.0_1 March 2023_ENG_vF
To view this piece of content from ml-eu.globenewswire.com, please give your consent at the top of this page.
About GlobeNewswire by notified
One Liberty Plaza - 165 Broadway
NY 10006 New York
GlobeNewswire by notified is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.
Subscribe to releases from GlobeNewswire by notified
Subscribe to all the latest releases from GlobeNewswire by notified by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from GlobeNewswire by notified
Aduro Clean Technologies Increases Size of Private Placement to $4 Million29.3.2023 02:12:40 CEST | Press release
NOT FOR DISTRIBUTION TO UNITED STATES NEWSWIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES SARNIA, Ontario, March 28, 2023 (GLOBE NEWSWIRE) -- Aduro Clean Technologies Inc. (“Aduro” or the “Company”) (CSE: ACT) (OTCQB: ACTHF) (FSE: 9D50), a Canadian developer of patented water-based technologies to chemically recycle plastics, and to transform heavy crude and renewable oils into feedstocks and higher-value fuels, is pleased to announce that, further to its news release dated March 8, 2023, it has increased the size of its non-brokered private placement of units (the “Units”) at $0.93 per Unit for gross proceeds of a minimum of $1,999,965 and up to a maximum of $4,000,000 (the “LIFE Offering”). Each Unit will consist of one (1) common share in the capital of the Company (each, a “Common Share”) and one-half (1/2) of one Common Share purchase warrant (each whole warrant, a “Warrant”). Each Warrant will be exercisable into one (1) Common Share (each, a “Warrant Share”) at a price o
ClearPoint Neuro Announces Exclusive Multi-Year Licensing Agreement with UCSF for Innovative Intra-Cerebral Cellular Delivery Platform28.3.2023 22:05:00 CEST | Press release
SOLANA BEACH, Calif., March 28, 2023 (GLOBE NEWSWIRE) -- ClearPoint Neuro, Inc. (NASDAQ: CLPT) (the “Company”), a global therapy-enabling platform company providing navigation and delivery to the brain, today announced an exclusive multi-year licensing agreement of intellectual property from UC San Francisco (UCSF) through its Innovation Ventures group to develop and commercialize a radially branching cellular delivery device for use both in the Operating Room under fluoroscopy/CT guidance and under MRI guidance. “This invention will help clinicians guide the delivery of biologic therapies — from stem cell transplants to gene therapy vectors — to specific locations in the human brain with real-time image guidance,” said Dr. Daniel Lim, MD, PhD, Professor of Neurological Surgery at UCSF. “By helping surgeons tailor biologic delivery to individual patient anatomy and specific diseases, I hope that this invention can contribute importantly to the successful treatment of neurological disor
Development of the Annual General Meeting of the BANK of Greenland28.3.2023 22:03:19 CEST | Press release
Minutes of General Meeting To Nasdaq OMX Copenhagen 28 March 2022 Company announcement no. 05/2023 Development of the Annual General Meeting of the BANK of Greenland Today, the BANK of Greenland held its Annual General Meeting in accordance with the Articles of Association and the previously published notice convening the meeting. The Annual General Meeting was attended by shareholders representing 1,049,468 votes, of which 612,498 votes were given by proxy to the Board of Directors, 62,821 votes were covered by instructions to holders of power of attorney and 115,455 votes of correspondance. The Board of Directors' Report on the Bank's activities during the past year The Chairman of the Board of Directors Gunnar í Liða presented the Board of Directors' report on the Bank's activities during the past year. The report of the Board of Directors was noted. The Chairman's report can be viewed on the Bank's website at www.banken.gl. The minutes of the Annual General Meeting will also be pub
Forløb af ordinær generalforsamling i GrønlandsBANKEN28.3.2023 22:03:19 CEST | pressemeddelelse
Referat af Generalforsamling Til Nasdaq OMX Copenhagen 28. marts 2023 Selskabsmeddelelse nr. 05/2023 Forløb af ordinær generalforsamling i GrønlandsBANKEN GrønlandsBANKEN har i dag afholdt ordinær generalforsamling i henhold til vedtægterne og tidligere offentliggjort indkaldelse. Generalforsamlingen var repræsenteret med 1.049.468 stemmer, heraf var 612.498 stemmer givet som fuldmagt til bestyrelsen, 62.821 stemmer var givet som instruktionsfuldmagt, mens 115.455 var afgivet som brevstemme. Bestyrelsens beretning om bankens virksomhed i det forløbne år Bestyrelsesformand Gunnar í Liða aflagde bestyrelsens beretning om bankens virksomhed i det forløbne år. Bestyrelsens beretning blev taget til efterretning. Formandens beretning kan ses på bankens hjemmeside www.banken.gl Generalforsamlingens protokollat vil senest 14 dage efter generalforsamlingens afholdelse ligeledes blive lagt på bankens hjemmeside. Godkendelse af årsrapporten for 2022, meddelelse om decharge for bestyrelse og direk
Zealand Pharma Increases its Share Capital as a Consequence of Exercise of Employee Warrants28.3.2023 22:00:00 CEST | Press release
Company announcement – No. 8 / 2023 Zealand Pharma Increases its Share Capital as a Consequence of Exercise of Employee Warrants Copenhagen, Denmark, March 28, 2023 – Zealand Pharma A/S (“Zealand”) (NASDAQ: ZEAL) (CVR-no. 20 04 50 78), a Copenhagen-based biotechnology company focused on the discovery and development of innovative peptide-based medicines, has increased its share capital by a nominal amount of DKK 34,594 divided into 34,594 new shares with a nominal value of DKK 1 each. The increase is a consequence of the exercise of warrants granted under several of Zealand Pharma's employee warrant programs. Employee warrant programs are part of Zealand Pharma’s incentive scheme, and each warrant gives the owner the right to subscribe for one new Zealand Pharma share at a prespecified price, the exercise price, in specific predefined time periods before expiration. For a more detailed description of Zealand Pharma’s warrant programs, see the company’s Articles of Association, which ar