For Aptahem, the second quarter continued to focus on the clinical development of drug candidate Apta-1 against sepsis. However, the company recently put the clinical phase Ia study on hold after making, what it called, interesting findings. BioStock talked to CEO Mikael Lindstam to get an update.
Aptahem’s drug candidate Apta-1 is designed to address several critical factors in the potentially life-threatening condition sepsis. An exaggerated immune response to a seemingly common infection often triggers sepsis. The goal of the candidate is to suppress the inflammatory response and restore the immune system‘s balance, while remaining safe without inducing side effects.
Sepsis, or suspected sepsis, is normally first treated with antibiotics. However, antibiotics do not always help, either because the root cause of sepsis is not bacterial or because of antibiotic resistance. Since sepsis can very quickly lead to multiple organ failure and, in the worst case, death, the time frame to start an effective treatment is tight. Therefore, Aptahem’s goal is to position Apta-1 as an emergency drug.
Two-part phase I clinical trial: 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 successfully conducted phase Ia in four cohorts, where the focus was on the safety and tolerability of Apta-1.
In the upcoming phase Ib proof-of-concept study, the company plans to assess Apta-1’s effect on an induced inflammatory state in healthy volunteers. The purpose of this phase is primarily to minimise the risk of the set-up for the subsequent phase II study and trigger partnerships. It is here that the first signs of the therapeutic potential of the candidate 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 the completion of the analyses.
To get an updated view of the current situation in the company, BioStock contacted the company’s CEO Mikael Lindstam.
Mikael, during phase Ia, more biomarkers were affected than previously observed. However, this may be a natural consequence of dose escalation. Has your CRO come closer to a possible explanation for this?
– This is something that we work on collectively under the guidance of the company’s CSO and other team members, as well as partners. The work runs excellently, and several different competencies are involved, which in itself is not new, but this is how we have acted since day 1 of the clinic’s start. 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 it is not obvious that this could be seen in the preclinical studies or at different dose levels.
What activities are ongoing at the company as these analyses progress?
– We continue our work to produce and maintain research reports, both internally and with our scientific partners. Another important task is to update regulatory documents, including all material for the clinical study. We prepare material for scientific writings. Business development is ongoing as well as meetings with KOLs to strengthen the scope for future clinical studies. We have also recruited a strong R&D resource, and we have made 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 already initiated contact with, something that can now be intensified after the summer break, while the autumn also will include various partner events.
Finally, what is the strategy for the rest of the year?
– Our goal is to finish the phase Ia study so that we can get started with the Ib as soon as possible. We see this as a strong point of inflexion for the company’s opportunities to strengthen Apta-1’s potential as a drug candidate and to be able to tie a partner to us. With these results, we can then look more clearly ahead to phase II, not only for ourselves and the risk minimisation we strive for, but also as a basis for the partner discussions we are having. Meanwhile, the scientific work will continue in parallel, which is necessary to get as optimised clinical development as possible.The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.