Herantis Pharma - Inconclusive topline results from AdeLE study
No additional benefit with Lymfactin identified Baseline differences and inconsistent outcome measures Negative market sentiment for now, more details Q2’21 Inconclusive topline results Herantis released topline results for the much-awaited Ph II AdeLE study for its VEGF-c gene therapy treatment, Lymfactin, in breast cancer-associated lymphedema (BCAL). Although light on details at this time we learnt that the results were inconclusive, and that while both the Lymfactin arm and the placebo arm saw clinically meaningful improvements, there was no discernible additional treatment benefit with Lymfactin, which is of course disappointing. Herantis highlight, however, that unexpectedly large differences in the baseline characteristics between the two groups coupled with suspected significant impacts on the outcome measures from confounding factors (such as the use of compression sleeves etc.) complicates drawing firm conclusions from the results. More data to follow in early Q2’21 Like the results from the CDNF programme a full webinar is planned for early Q2’21 where the actual data will be presented in more detail.
What baseline characteristics varied between the groups, their degree, and likely directional impact on the results (i.e. whether the groups were skewed in favour of the control arm or not) will be relevant points to consider. With Herantis still carrying out in-depth analysis of the data, potential findings on patient-, disease-, or treatment-related factors that may shed light on the results will be worth considering.
Most interesting will be to understand how Herantis plan to proceed with the Lymfactin programme and if another clinical study will be undertaken, how the learnings from the AdeLE trial could be incorporated to improve its chances of establishing a potential benefit for Lymfactin. Negative for the share The market has taken the news of the results negatively as questions are raised over the future of the Lymfactin programme. Thi....