Ascelia Pharma: Full study report from the SPARKLE study and Q3 report

Yesterday evening the company announced the completion of the full study report from the Orviglance phase 3 study – SPARKLE.

In beginning of May 2024, the company announced the headline data from the SPARKLE study and 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 in patients with severely impaired kidney function. Now we get more insight into data and results of the secondary endpoint. This support the NDA process and potential clinical value of Orviglance. The company expect to file the NDA to FDA by mid-2025 to obtain regulatory approval.

Primary endpoint concludes improved visualization with Orviglance
As previously announced, the primary efficacy of Orviglance in liver MRI was demonstrated by improved visualization of focal liver lesions in Orviglance-enhanced* images compared to unenhanced images. For this endpoint, three independent, blinded readers assessed border delineation (BD) and lesion contrast (LC) on scales from 1 (‘poor’) to 4 (‘excellent’) of all lesions for each patient**. Overall, Orviglance enhanced visualization from ‘moderate’ or ‘good’ to ‘good’ or ‘excellent’.

• For unenhanced images, the median BD and LC scores ranged from 2.1 to 3.0 across readers
• For Orviglance-enhanced images, the median BD and LC scores increased to 3.0 and 4.0 across readers
• These increases were statistically significant (p<0.001) for all three readers
• Orviglance also provided superior visualization compared to unenhanced images across pre-defined sub-groups for all three readers. These sub-groups include lesion type, age, sex, degree of renal impairment, and magnetic field strength

Secondary endpoints reinforce successful SPARKLE outcomes
The results of the secondary efficacy endpoints support the positive primary analysis and confirm the robustness of the positive results.

Key secondary efficacy analyses include e.g.,

• Detection of lesions: across all readers at least one additional lesion was detected in 40-52% of patients with Orviglance compared to unenhanced MRI across readers
• Detection of small lesions: The mean size of the smallest lesions was 2 mm smaller with Orviglance than with unenhanced MRI

Quote from the CSO Andreas Norlin in Ascelia Pharma “ The positive and robust results for SPARKLE confirm our confidence in Orviglance and will be valuable in our discussions with regulators to advance Orviglance to approval”.

This morning they released they Q3 report:

Operating result of SEK -17,8m (SEK -21,4m)

Earnings per share of SEK -0,42 (SEK -0,63)

Cash flow from operations of SEK -17m (SEK -31m)

Liquid assets and marketable securities of SEK 95,7m (SEK 39m)

The company carried out a fully subscribed rights issue in the quarter of SEK 105m gross.

The company will present Orviglance SPARKLE data to be presented as late breaking abstract at Kidney Week 2024.

Read our latest One pager here: Ascelia Pharma (One-pager)

We host event with Ascelia Pharma, Monday 11th of November - sign up here: Q3 event

Disclaimer: HC Andersen Capital receives payment from Ascelia Pharma for a Digital IR/Corporate Visibility subscription agreement. /Claus Thestrup 8:30 AM 07.11-2024.