The online presentations and live event are available from this link and on the company’s website ( www.ascelia.com ).
 
The pivotal Phase 3 study for Orviglance, 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 had high statistical significance (P values <0.001).

These positive headline results from SPARKLE conclude clinical development of Orviglance with consistent positive efficacy and safety data from nine clinical studies with a total of 286 patients and healthy volunteers.

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.

In the Investor Update executive management:

• Further explains the strong headline results
• Shares plans for the upcoming regulatory and commercialization activities
• Outlines value creation opportunities ahead for Ascelia Pharma

The following presentations are available in the Investor Update online :
 
Take Ascelia Pharma to the Next Level
Magnus Corfitzen, CEO shares his view on the strong headline results from SPARKLE and provides an overview of key next steps and milestones.

Our objective is to reach a timely submission and approval by the US FDA as an orphan drug with an optimal label for use in the target population. As we move our focus to the regulatory submission and approval, we will in parallel continue to advance launch readiness and our dialogue with potential commercialization partners,

“Ascelia has met another major milestone, and we look forward to meeting the next milestones on our journey to making Orviglance available to patients and transforming Ascelia to a commercial stage company”, he says.
 
Advance Orviglance from Phase 3 to Approval
CSO Andreas Norlin, explains the strong Phase 3 headline results where three out of three readers scored primary visualization variables significantly higher with Orviglance than without. These positive results mark the successful completion of clinical development for Orviglance.

The Company expects to submit the NDA file for FDA regulatory approval by mid-2025. The focus of the Company is now on completing preparations required prior to submission. These include:

• Full Clinical Study Report early Q4 2024
• Conclusions from FDA pre-submission meeting by Q1 2025

Progress Commercialization Readiness
Julie Waras Brogren, Deputy CEO describes how 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 strategy, based on extensive market research, is in place for a focused, ambitious launch for a well-defined vulnerable patient population. The focus ahead is to progress launch readiness and establish commercial partnerships.

“Our commercialization strategy is to launch through partners with the potential for an Ascelia Pharma led launch in the US. The overall ambition is to secure the optimal balance between value creation, investment required and future revenues”, she says.