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Ascelia Pharma

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Datum Källa Rubrik Typ Alternativ
2024-05-16 Ascelia Pharma Quarterly Report Q1: Primary Endpoint Met with Strong Headline Results in Orviglance Phase 3 Study Rapporter Ladda ner | Visa Stäng
2024-05-16 Ascelia Pharma Kvartalsrapport Q1: Primärt effektmått uppnått med starka headline-resultat i fas 3-studien med Orviglance Rapporter Ladda ner | Visa Stäng
2024-05-08 Penser Access by Carnegie Penser Access by Carnegie: Ascelia Pharma: Medvind i seglen Pressreleaser Visa Stäng
2024-05-07 Ascelia Pharma Welcome to Ascelia Pharma Investor Update: Bringing Orviglance to Patients Pressreleaser Ladda ner | Visa Stäng
2024-05-07 Ascelia Pharma Välkommen till Ascelia Pharma uppdatering till investerare: Att föra Orviglance till patienterna Pressreleaser Ladda ner | Visa Stäng
2024-05-06 Ascelia Pharma Bulletin from the Annual General Meeting in Ascelia Pharma AB on 6 May 2024 Pressreleaser Ladda ner | Visa Stäng
2024-05-06 Ascelia Pharma Kommuniké från årsstämma den 6 maj 2024 i Ascelia Pharma AB Pressreleaser Ladda ner | Visa Stäng
2024-05-02 Ascelia Pharma Ascelia Pharma Successfully Meets Primary Endpoint with Strong Headline Results in Orviglance Phase 3 Study Pressreleaser Ladda ner | Visa Stäng
Pressreleaser | 2 May 2024 | Ascelia Pharma

Ascelia Pharma Successfully Meets Primary Endpoint with Strong Headline Results in Orviglance Phase 3 Study

Ascelia Pharma AB (publ) (ticker: ACE), a biotech focused on improving the life of people living with rare cancer conditions, today announced that liver imaging drug candidate, Orviglance®, significantly improved visualization of focal liver lesions, successfully meeting the primary endpoint in the pivotal Phase 3 study SPARKLE. Investors and analysts are invited to the virtual Investor Update: “Bringing Orviglance to Patients”, on Tuesday, 7 May at 14:00 CEST

  • The Phase 3 study demonstrated strong superiority in visualization of focal liver lesions with Orviglance (CMRI) vs. unenhanced MRI with statistical significance for all three readers (<0.001)
  • Orviglance is in development as a first-in-class contrast agent for use in liver MRI in patients with severely impaired kidney function and has been granted FDA Orphan Drug Designation
  • Orviglance addresses a global USD 800 million market annually
  • The Phase 3 data marks the completion of Orviglance clinical development with nine studies in 286 patients and healthy volunteers
  • Submission of the New Drug Application (NDA) file to the US Food and Drug Administration (FDA) is expected by mid-2025
  • Investors, analysts and media are invited to the virtual Investor Update and live Q&A on next steps: “Bringing Orviglance to Patients”, on Tuesday, 7 May 2024 at 14:00 CEST
The pivotal Phase 3 study, SPARKLE, successfully met the primary endpoint and demonstrated that the company’s magnetic resonance imaging (MRI) contrast agent, Orviglance significantly improved the visualization of focal liver lesions compared to unenhanced MRI. The results for all three readers were highly statistically significant (P values <0.001).
 
The reliability of the data is strong and conclusive for all readers – this includes an acceptable level of variability.
 
Common adverse events in this vulnerable patient population were in line with previous studies with Orviglance, such as mild- to moderate nausea. No serious adverse drug reactions were observed.
 
“We are thrilled to announce these strong and convincing Phase 3 results for Orviglance. This is the most significant milestone achievement for Ascelia Pharma so far”, said Magnus Corfitzen, CEO of Ascelia Pharma. “Following considerable challenges during the SPARKLE study, we are very excited to complete the Orviglance clinical development with these strong results in Phase 3. We now look forward to advancing Orviglance through the registration process and make it available for patients.”
 
The Company will now focus on bringing Orviglance through the regulatory submission and approval process. In parallel, we will continue to advance launch readiness and dialogue with potential commercialization partners to make Orviglance available to patients who need high-quality liver imaging without gadolinium-related safety risk.
 
“On behalf of the entire Ascelia Pharma team, I would like to thank patients and investigators involved in the SPARKLE study as well as other partners instrumental in completing the successful data read-out. We look forward to discussing the results with the medical community and regulatory authorities”, said Magnus Corfitzen.
 
The Company expects to submit the New Drug Application (NDA) file to the US Food and Drug Administration (FDA) by mid-2025 to obtain regulatory approval.
 
Investors, analysts, and media are invited to the virtual Investor Update: “Bringing Orviglance to Patients”, on Tuesday, 7 May 2024 at 14:00 CEST. In this update and live Q&A, executive management will further explain the strong headline results and share plans for the upcoming regulatory and commercialization activities. A link to the event will be available on the company’s website ( www.ascelia.com ).
 
Clinical development of Orviglance has now been completed with consistent positive efficacy and safety data from 286 patients and healthy volunteers in nine studies, of which the SPARKLE is the last and pivotal study. Patient enrollment in the global multi-center SPARKLE study was completed early 2023, with MRI data from 85 patients with known or suspected focal liver lesions and severely impaired kidney function. In accordance with regulatory requirements, the improvement of visualization of lesions was evaluated by three independent radiologist readers. In mid-2023, the unexpected discovery of high intra-reader variability in the study image scoring by the readers prevented the Company from evaluating the efficacy data from SPARKLE. Therefore, a new evaluation of the images with new readers was required. The company successfully completed the re-evaluation according to the planned timeline with the announcement today.
 
Orviglance has been granted an Orphan Drug Designation by the US Food and Drug Administration (FDA) for liver MRI in patients with severely impaired kidney function. These patients have the highest risk of developing the serious and potentially fatal condition Nephrogenic Systemic Fibrosis (NSF) after exposure to the currently available gadolinium-based contrast agents. Regulatory bodies have issued warnings for the use of these agents in this vulnerable patient population. Therefore, there is a need for an alternative solution to detect and visualize focal liver lesions in patients with impaired kidney function, who today typically receive inferior unenhanced MRI. Liver MRI is a cornerstone in cancer care, as liver metastases are common in many cancer types and often the cause of mortality. Orviglance aims to give patients with impaired kidney function access to safe and effective liver imaging to live longer and healthier lives. The unmet need for these patients represents an addressable market potential of USD 800 million globally.
 
*The Company considers mid-2025 to be the period from the second half of Q2 to the first half Q3. 

Contacts

Magnus Corfitzen, CEO
Email:  moc@ascelia.com
Tel: +46 735 179 118

Julie Waras Brogren, Deputy CEO (Finance, Investor Relations & Commercial)
Email:  jwb@ascelia.com
Tel: +46 735 179 116

This information was submitted for publication, through the agency of the contact persons set out above.

About Us

Ascelia Pharma is a biotech company focused on orphan oncology treatments. We develop and commercialize novel drugs that address unmet medical needs and have a clear development and market pathway. The company has two drug candidates – Orviglance and Oncoral – in clinical development. Ascelia Pharma has global headquarters in Malmö, Sweden, and is listed on Nasdaq Stockholm (ticker: ACE). For more information, please visit  http://www.ascelia.com.

About Orviglance
Orviglance (manganese chloride tetrahydrate) is a novel oral contrast agent for MR-imaging developed to improve the detection and visualization of focal liver lesions (including liver metastases and primary tumors) in patients with reduced kidney function. These patients are at risk of serious side effects from the currently available class of gadolinium-based contrast agents. Orviglance, has been granted an Orphan Drug Designation by the US Food and Drug Administration (FDA). A clinical program of nine studies, including the pivotal global Phase 3 study SPARKLE, has successfully been completed with strong and consistent efficacy and safety results.

 About Oncoral
Oncoral is a novel irinotecan chemotherapy tablet developed initially for the treatment of gastric cancer. Irinotecan chemotherapy has an established potent anti-tumor effect. Oncoral is a daily tablet with the potential to offer better patient outcomes with improved safety following the daily dosing at home compared to intravenous high-dose infusions at the hospital. Following successful Phase 1 results, Oncoral is now prepared for Phase 2 clinical development.

This information is information that Ascelia Pharma is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 2024-05-02 11:12 CEST.

Attachments

Ascelia Pharma Successfully Meets Primary Endpoint with Strong Headline Results in Orviglance Phase 3 Study

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2024-05-02 Ascelia Pharma Ascelia Pharma uppnår framgångsrikt det primära effektmåttet med starka headline-resultat i fas 3-studien med Orviglance Pressreleaser Ladda ner | Visa Stäng
2024-04-18 Ascelia Pharma Ascelia Pharma Draws Down SEK 15 Million Second Tranche Under Existing Loan Facility Pressreleaser Ladda ner | Visa Stäng
2024-04-18 Ascelia Pharma Ascelia Pharma utnyttjar den andra tranchen om 15 MSEK under befintlig lånefacilitet Pressreleaser Ladda ner | Visa Stäng
2024-04-10 Ascelia Pharma Ascelia Pharma Reports SPARKLE Image Reading Completion and Expects Headline Results First Half of May 2024 Pressreleaser Ladda ner | Visa Stäng
2024-04-10 Ascelia Pharma Ascelia Pharma rapporterar att SPARKLE-bildläsningsfasen är avslutad och förväntar sig headline-resultat i första halvan av maj 2024 Pressreleaser Ladda ner | Visa Stäng
2024-04-08 Ascelia Pharma Årsredovisning 2023: Solida framsteg med slutförd patientrekrytering till Orviglance fas 3 och förväntat headline-resultat i maj 2024 Rapporter Ladda ner | Visa Stäng
2024-04-08 Ascelia Pharma Annual Report 2023: Solid Progress with Orviglance Phase 3 Patient Recruitment Completed and Headline Results Expected by May 2024 Rapporter Ladda ner | Visa Stäng
2024-03-27 Ascelia Pharma Kallelse till årsstämma i Ascelia Pharma AB Pressreleaser Ladda ner | Visa Stäng
2024-03-27 Ascelia Pharma Notice of Annual General Meeting in Ascelia Pharma AB Pressreleaser Ladda ner | Visa Stäng
2024-02-21 Penser Access by Carnegie Penser Access by Carnegie: Interview with Ascelia Pharma - Carnegie Investment Bank - Feb 21th 2024 Pressreleaser Visa Stäng
2024-02-12 Penser Access by Carnegie Penser Access by Carnegie: Ascelia Pharma - Finansiering på plats, avgörande data i maj Pressreleaser Visa Stäng
2024-02-12 Redeye Redeye: Ascelia Pharma Q4 2023 - On track with easing financial pressure Pressreleaser Ladda ner | Visa Stäng
2024-02-09 Ascelia Pharma Q4 and Full Year Report 2023: Strengthened Financial Position Ahead of SPARKLE Phase 3 Study Headline Results in May Rapporter Ladda ner | Visa Stäng
2024-02-09 Ascelia Pharma Q4 och bokslutskommuniké 2023: Stärkt finansiell position inför headline-resultat i maj för den kliniska fas-3 studien SPARKLE Rapporter Ladda ner | Visa Stäng
2024-02-04 Ascelia Pharma Ascelia Pharma Secures Financing of up to SEK 35 Million Pressreleaser Ladda ner | Visa Stäng
2024-02-04 Ascelia Pharma Ascelia Pharma säkrar finansiering om upp till 35 MSEK Pressreleaser Ladda ner | Visa Stäng
2024-01-24 Ascelia Pharma Översiktsartikel om Orviglance publicerad i Investigative Radiology Pressreleaser Ladda ner | Visa Stäng
2024-01-24 Ascelia Pharma Orviglance Review Article Published in Investigative Radiology Pressreleaser Ladda ner | Visa Stäng
2024-01-24 Ascelia Pharma Nomination Committee Appointed for AGM 2024 in Ascelia Pharma AB Pressreleaser Ladda ner | Visa Stäng
2024-01-24 Ascelia Pharma Valberedning utsedd i Ascelia Pharma AB inför årsstämman 2024 Pressreleaser Ladda ner | Visa Stäng
2023-12-07 Ascelia Pharma Ascelia Pharma meddelar start av bildläsningsfasen och bekräftar resultat från fas 3 SPARKLE senast i maj 2024 Pressreleaser Ladda ner | Visa Stäng
2023-12-07 Ascelia Pharma Ascelia Pharma Announces Start of Image Reading Phase and Re-confirms Phase 3 SPARKLE Results by May 2024 Pressreleaser Ladda ner | Visa Stäng
2023-12-06 Finansinspektionen Finansinspektionen: Flaggningsmeddelande i Ascelia Pharma AB Pressreleaser Visa Stäng
2023-11-30 Ascelia Pharma Ändring av antalet aktier och röster i Ascelia Pharma AB Pressreleaser Ladda ner | Visa Stäng
2023-11-30 Ascelia Pharma Change in Number of Shares and Votes in Ascelia Pharma AB Pressreleaser Ladda ner | Visa Stäng
2023-11-13 Ascelia Pharma Kommuniké från extra bolagsstämma den 13 november 2023 i Ascelia Pharma AB Pressreleaser Ladda ner | Visa Stäng
2023-11-13 Ascelia Pharma Bulletin from the Extraordinary General Meeting in Ascelia Pharma AB on 13 November 2023 Pressreleaser Ladda ner | Visa Stäng
2023-11-09 Ascelia Pharma Ascelia Pharma beslutar om omvandling av C-aktier till stamaktier för leverans till deltagare i incitaments-program Pressreleaser Ladda ner | Visa Stäng
2023-11-09 Ascelia Pharma Ascelia Pharma resolves on conversion of series C shares into ordinary shares for delivery to participants in incentive program Pressreleaser Ladda ner | Visa Stäng
2023-11-09 Penser Access Penser Access: Blickarna mot maj - Ascelia Pharma Pressreleaser Visa Stäng
2023-11-09 Redeye Redeye: Ascelia Q3 update - On track for a SPARKLE result in May 2024 Pressreleaser Ladda ner | Visa Stäng
2023-11-08 Ascelia Pharma QUARTERLY REPORT Q3 2023: Re-evaluation of SPARKLE Phase 3 Study Images Progresses According to Plan Rapporter Ladda ner | Visa Stäng
2023-11-08 Ascelia Pharma KVARTALSRAPPORT Q3 2022: Den ny utläsning av bilderna från fas 3-studien SPARKLE fortskrider enligt planen Rapporter Ladda ner | Visa Stäng
2023-10-19 Ascelia Pharma NOTICE OF EXTRAORDINARY GENERAL MEETING IN ASCELIA PHARMA AB Pressreleaser Ladda ner | Visa Stäng
2023-10-19 Ascelia Pharma KALLELSE TILL EXTRA BOLAGSSTÄMMA I ASCELIA PHARMA AB Pressreleaser Ladda ner | Visa Stäng
2023-10-04 Ascelia Pharma Ascelia Pharma får översiktsartikel om Orviglance accepterad för publicering i Investigative Radiology Pressreleaser Ladda ner | Visa Stäng
2023-10-04 Ascelia Pharma Ascelia Pharma Gets Acceptance for Publication of Orviglance Review Article in Investigative Radiology Pressreleaser Ladda ner | Visa Stäng
2023-09-18 Redeye Redeye: Ascelia Pharma - All attention on the top priority Pressreleaser Ladda ner | Visa Stäng
2023-09-13 Ascelia Pharma Ascelia Pharma to Reach Headline Results from SPARKLE Re-Evaluation by May 2024 with Current Funding Pressreleaser Ladda ner | Visa Stäng
2023-09-13 Ascelia Pharma Ascelia Pharma når headline-resultat från SPARKLE-utläsningen i maj 2024 med nuvarande finansiering Pressreleaser Ladda ner | Visa Stäng
2023-08-31 Ascelia Pharma Ascelia Pharma significantly reduces organization to reach SPARKLE headline results Pressreleaser Ladda ner | Visa Stäng
2023-08-31 Ascelia Pharma Ascelia Pharma gör omfattande neddragning av organisationen för att nå headline-resultat med SPARKLE Pressreleaser Ladda ner | Visa Stäng
2023-08-21 Penser Access Penser Access: I väntan på nästa milstolpe - Ascelia Pharma Pressreleaser Visa Stäng
2023-08-18 Ascelia Pharma Halvårsrapport 2023: Ny utläsning krävs efter intraläsarinkonsistens rörande poängsättning av bilder av läsare från fas 3-studien SPARKLE Rapporter Ladda ner | Visa Stäng
2023-08-18 Ascelia Pharma Half-Year report 2023: Re-evaluation required after intra-reader inconsistency in scoring of images from phase 3 study SPARKLE Rapporter Ladda ner | Visa Stäng
2023-08-09 Ascelia Pharma Ascelia Pharma ger förtydliganden kring intraläsarvariabilitet vid utläsningen av bilder i SPARKLE-studien Pressreleaser Ladda ner | Visa Stäng
2023-08-09 Ascelia Pharma Ascelia Pharma provides clarifications around the intra-reader variability in read-out of images in the SPARKLE study Pressreleaser Ladda ner | Visa Stäng
2023-08-09 Penser Access Penser Access: Oväntat utfall - Ascelia Pharma Pressreleaser Visa Stäng
2023-08-09 Redeye Redeye: Ascelia Pharma - SPARKLE is blurred Pressreleaser Ladda ner | Visa Stäng
2023-08-07 Ascelia Pharma Ny utläsning krävs efter intraläsarinkonsistens rörande poängsättning av bilder av läsare från fas 3-studien SPARKLE Pressreleaser Ladda ner | Visa Stäng
2023-08-07 Ascelia Pharma Re-Evaluation Required After Intra-Reader Inconsistency in Scoring of Images from Phase 3 Study SPARKLE Pressreleaser Ladda ner | Visa Stäng
2023-06-20 Penser Access Penser Access: Sanningens ögonblick - Ascelia Pharma Pressreleaser Visa Stäng
2023-06-16 Ascelia Pharma Vid ESGARs årsmöte 2023 presenterade Ascelia Pharma Orviglance-data från studien med nedsatt leverfunktion samt var värd för en Q&A med experter inom leveravbildning Pressreleaser Ladda ner | Visa Stäng
2023-06-16 Ascelia Pharma Ascelia Pharma presented Orviglance Hepatic Impairment Data and hosted a Q&A with liver imaging experts at the 2023 ESGAR Annual Meeting Pressreleaser Ladda ner | Visa Stäng

Kommande händelser

15 Aug 2024 | Kvartalsrapport 2024-Q2
7 Nov 2024 | Kvartalsrapport 2024-Q3
7 Feb 2025 | Bokslutskommuniké 2024

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