Aptahems drug candidate Apta-1 targets several key factors in life-threatening inflammatory conditions such as sepsis with the goal of reducing severe uncontrolled inflammatory reactions, so-called “inflammatory storm”. Since the start of the Phase 1 clinical study in healthy volunteers, which is a study to evaluate safety and tolerability, 4 cohorts of healthy volunteers have been dosed with increasing doses of Apta-1.
The study was temporarily paused
In July of this year, Aptahem announced that it had made 'interesting findings' in the Phase I study, and after the Data Review Committee had reviewed these data, the committee recommended that Aptahem perform additional analyses of certain clinical biomarkers. This led to the study being temporarily paused. A couple of weeks ago, Aptahem announced that these additional analyses showed promising results and, after compiling the data, it was recently announced that Apta-1 has good safety.
The ongoing Phase I clinical study is divided into two parts: Phase Ia and Phase Ib. So far, the company has conducted four cohorts in Phase Ia to study safety. In the upcoming Phase Ib study, the company intends to evaluate the effect of Apta-1 on a provoked inflammatory response in healthy volunteers. Phase Ib aims to study Apta-1's effect under a simulated inflammatory condition, in order to optimize the study design for the upcoming Phase II study. In the Phase II study, the effect of Apta-1 on patients will be studied.
Comments from the CEO
To find out more about where Aptahem is right now and what the plans are going forward, BioStock contacted CEO Mikael Lindstam.
Mikael, what do the new analyses show?
– Since the analyses are part of the study that is not yet completed, I cannot fully answer this question today, but we will have to wait for the final summary. However, I would like to clarify that none of the healthy volunteers in the study have experienced side effects of clinical significance while participating in the study. All subjects have left the completed cohorts completely healthy. The phase 1a study is still not completed and is a so-called double-blind study, i.e. some of the subjects receive the active substance and some receive placebo. This code must not be broken prematurely and the study must therefore be fully completed before full reporting of data. We look forward to reporting results when the phase 1a study is completed.
– We see a tendency for the results to be in line with what we have seen in our preclinical studies, which is promising for the continued clinical development. We feel strengthened for the continued work and are now finalizing the compilation of the complementary clinical analyses.
So you couldn't see anything that could have caused the study to be terminated or paused further?
– No, not what we have seen so far and we expect to resume the study.
The next step is to release the temporary pause. What does the path forward look like?
– We expect to continue the study as planned. With the additional clinical analyses that we have studied, these have contributed to some new insights and we are really looking forward to completing the entire phase 1 study. The Ib part of the study will be particularly interesting, where we will hopefully be able to determine the effectiveness of Apta-1 on acutely provoked systemic inflammation in healthy volunteers.
The study is now a bit delayed, how do you see the timetables going forward – will they be kept despite the temporary pause?
– It is a bit early to comment on this now and keeping to the original timeline will be a challenge given the additional analyses that have been performed. Our ambition is to continue the study as soon as possible. Forecasts for estimated time always involve a certain amount of uncertainty as we depend on the response from authorities, the time for the next time slot to include trial subjects and other factors that are beyond our control. We are doing everything we can to move forward as quickly as possible.
In conclusion. What else is happening right now at Apathem?
– A lot of focus is on continued development of Apta-1, also from a pre-clinical perspective both internally and externally. The team is currently collaborating with Örebro University to compile new data that I look forward to reporting as soon as possible. We are also working on new scientific manuscripts to submit to an appropriate journal. The research and development team has recently brought in a very competent resource, which we are already seeing good effects from. Business development is important and I will be out in the field this autumn in slightly different contexts. Finally, the most important focus now is to get the go-ahead to continue the clinical phase 1 study.