#Sweden #Lund #Hansa Biopharma #imlifidase #Guillain-Barré

Hansa Biopharma's 15-HMedIdeS-09 Phase 2 Study Results

Hansa Biopharma, a prominent name in the biopharmaceutical field, has recently shared encouraging results from its 15-HMedIdeS-09 Phase 2 study, which involved a novel treatment for Guillain-Barré Syndrome (GBS). This study focused on the use of Imlifidase, an innovative IgG-cleaving enzyme, and its promising implications for patients suffering from this debilitating condition.

Overview of the Study

The Phase 2 trial was a single-arm study that included 30 adult participants diagnosed with severe GBS and examined the efficacy of Imlifidase in combination with intravenous immunoglobulin (IVIg). The objective was to assess whether this novel approach could expedite recovery and improve the overall quality of life for patients.

The results painted a promising picture: patients treated with a single dose of Imlifidase (0.25 mg/kg) alongside IVIg exhibited significant improvements in their functional status. In particular, the study reported a rapid recovery of muscle strength and a significant decrease in the time it took for patients to regain the ability to walk independently. Remarkably, the median time for patients to reach a functional status where they could walk without assistance was just 16 days.

Comparative Analysis Against IGOS

Further analysis was conducted to compare these findings against data from the International Guillain-Barré Syndrome Outcome Study (IGOS). It was revealed that those treated with Imlifidase showed a return to independent walking approximately six weeks sooner than patients in the IGOS group who received only IVIg treatment.

Statistical examinations highlighted that participants in the Hansa Biopharma trial were 6.4 times more likely to walk independently at one week post-treatment and 4.2 times more likely at the four-week mark compared to the IGOS group's outcomes. These statistics underlie the effectiveness of Imlifidase in facilitating faster recovery for GBS patients.

Expert Insights

Dr. Hitto Kaufmann, Chief Research and Development Officer at Hansa Biopharma, emphasized the significance of these results, stating that they underline Imlifidase's potential as a transformative treatment for GBS. Unlike existing therapies, Imlifidase provides a quick enzymatic solution to reduce IgG levels, thereby halting nerve damage associated with GBS and improving patient recovery outcomes.

Professor Shahram Attarian, who led the study, acknowledged the importance of early mobility in the recovery process for GBS patients. Achieving such milestones early on in treatment indicates a significant step towards restoring patient independence and overall quality of life.

Results Summary

Throughout the duration of the 15-HMedIdeS-09 study, the data showcased that:

• - 37% of patients could walk independently within the first week, with an average muscle strength improvement of 10.7 points.
• - After eight weeks, 67% were capable of walking independently, while many patients regained the ability to run.
• - At the six-month follow-up, 63% had either no functional disability or could run, marking a significant recovery rate.

The treatment was well-tolerated by participants with no serious adverse reactions, reinforcing the safety profile of Imlifidase.

Conclusion

Hansa Biopharma is on a promising path with Imlifidase, which has demonstrated its capability to address an urgent medical need in treating GBS, a condition with limited previous options. As the company moves forward, it emphasizes its commitment to developing innovative solutions for patients suffering from IgG-mediated autoimmune diseases. Notably, more details regarding the study will be discussed in an upcoming conference call on December 18, further shedding light on these groundbreaking findings.

This development marks a crucial step not just for Hansa Biopharma but also for the broader medical community, as it opens avenues for more effective treatment strategies against Guillain-Barré Syndrome and similar autoimmune disorders.