Aptahems drug candidate Apta-1 is designed to address multiple critical factors in the potentially life-threatening condition of sepsis, which can be triggered by an exaggerated immune response to a seemingly simple infection. The goal of the candidate is to dampen the inflammatory response and restore the balance of the immune system, while being safe without inducing side effects.
Sepsis, or suspected sepsis, is normally treated first with antibiotics. However, antibiotics do not always help, either because the cause is not bacterial or because it may be antibiotic resistance. Since sepsis can very quickly lead to multiple organ failure and, in the worst case, death, the time window to initiate effective treatment is narrow. Therefore, Aptahem's goal is to position Apta-1 as an emergency drug.
Two-part clinical phase I study: phase Ia and phase Ib
Aptahem's clinical phase I study is divided into two parts: phase Ia and phase Ib. During the spring, Aptahem has successfully completed four cohorts in phase Ia, where the focus has been on the safety and tolerability of the drug candidate.
In the upcoming Phase Ib proof-of-concept study, the company plans to assess Apta-1's effect on an induced inflammatory condition in healthy volunteers. The purpose of this phase is primarily to minimize risk for the subsequent Phase II study and to trigger partnerships. This is where the first signs of the candidate's therapeutic potential may appear.
Comments from the CEO
On July 17, Aptahem announced that it had made 'interesting findings' in the Phase Ia study and that the Data Review Committee recommended further analyses. The study has since been paused pending completion of the analyses.
To get an updated situation, BioStock contacted the company's CEO. Mikael Lindstam.
Mikael, during cohorts 1–4 you saw that more biomarkers – than you had previously observed – were affected. However, this may be a natural consequence of a dose escalation. Has your CRO come closer to a possible explanation for this?
– This is something that we are working on together under the leadership of the company's CSO and other team members and partners. The work is working excellently and several different skills are involved, which in itself is not new, but this is how we have acted since day 1 of the start of the clinic. The fact that we have seen new markers is interesting from the perspective that we are studying Apta-1 in humans for the first time and that it is not obvious that this could be seen in the preclinical studies or at different dose levels.
What is happening in the company as these analyses progress?
– We are working on our ongoing work to produce and maintain research reports, both internally and with our scientific partners. Another important part is updating regulatory documents, including all material for the clinical study. We are preparing material for scientific publications. Business development is ongoing, as well as meetings with KOLs to strengthen for future clinical studies. We have also recruited a strong resource for R&D and we have had adjustments elsewhere to adapt to the current operational set-up.
Are there any updates on potential collaboration and licensing partners?
– We have follow-up meetings with the potential partners that we have previously initiated contact with, something that can now be intensified after the summer break, and that the autumn contains various partner events.
Finally, what does the strategy for the business look like for the rest of the year?
– That we complete phase Ia and that we can quickly get started with Ib, which we see as a strong inflection point for the company's opportunities to strengthen Apta-1's potential as a drug candidate and thereby be able to attract a partner. With these results, we can then look more clearly ahead to phase II, not only for ourselves and the risk minimization we strive for, but also as a basis for the partner discussions we are having. The scientific side will continue to be tough, which is necessary to achieve the most optimized clinical development possible.