Aptahems main candidate Apta-1 targets several key factors in severe inflammatory conditions, such as sepsis, with the goal of reducing severe inflammatory reactions. Since the start of the Phase I clinical study, four patient groups of healthy volunteers have been dosed with increasing doses of Apta-1. The aim of the study is to evaluate safety and tolerability.
Added studies in the phase Ia study
In July of this year, Aptahem announced that there had been 'interesting findings' in the Phase I study, and that the Data Review Committee (DRC) recommended that Aptahem conduct further analyses of certain clinical biomarkers. This led to the study being temporarily paused. The subsequent analysis showed interesting biomarkers and good safety.
Phase Ia study completed
Based on the analyses conducted in the fall of 2023, Aptahem decided to terminate the Phase Ia study in healthy volunteers. The company announced that it was satisfied with the number of cohorts studied and that it could also save time for the continued clinical development program. An analysis and compilation of the unblinded results from the study has begun and the preliminary study report will then be submitted to the authorities. In parallel, planning is underway for the next clinical study, the company's first proof-of-concept study.
CEO comments
To learn more about the highlights of 2023, as well as the company's expectations regarding the upcoming PoC study, BioStock contacted CEO Mikael Lindstam for a comment.
Mikael, can you briefly summarize the most important progress in Aptahem in 2023?
– During the year, we have focused on the phase I study where we conducted four cohorts of healthy volunteers in increasing doses of Apta-1 to study safety and tolerability. After the additional analyses that we conducted after the summer, on the recommendation of the DRC, we saw that Apta-1 is well tolerated and none of the participants in the study experienced any side effects of clinical significance. With this and the added analyses, we felt satisfied with conducting only four cohorts and believe that the information we have collected is sufficient to take the next step in the clinical development program.
– We have had good cooperation with CHDR, who carried out the study, and also good dialogues with authorities and other parties during the year. The response we have received from various sources, considering the company's current development status, including the companies and KOLs we have met at various events, has been positive.
– The results we have shown over the years leading up to the first part of the Phase I study so far further strengthen our belief that Apta-1 has a unique ability that could successfully treat serious inflammatory conditions.
What was the basis for the decision to end the Phase Ia study in November?
– As mentioned, during the analysis work after the summer, we assessed that we had received enough data and information about Apta-1 regarding safety and tolerability to complete that part of the study and get to the start of PoC studies more quickly after the time delay of the additional studies performed.
When do you expect the final results from the blinded phase Ia study to be published?
– This work is ongoing and I will return as soon as we have received the preliminary report, which will then go to the authority and then it is in their hands. However, we hope to be able to announce preliminary results while we await the authority's final approval.
You recently announced your intention to conduct a partially guaranteed rights issue of units between January 15 and January 29, 2024, provided that an extraordinary general meeting approves the proposal on January 9, 2024. How do you intend to use the issue proceeds, which will amount to a maximum of SEK 34,6 million?
– The issue proceeds will be used in the manner we announced in the press release, i.e. to prepare a proof-of-concept study and to complete the Phase Ia part, as well as for ongoing costs of course.
Series TO8 warrants are attached to these units, with a subscription period between April 15–April 29, 2024, which means that you can receive a maximum of approximately SEK 51,9 million in additional capital during the spring. How far will that capital injection take you?
– Our goal is to reach an important milestone with TO8, i.e. through the PoC study, demonstrate the positive effect of Apta-1 in humans, something that is now necessary to create a sharp dialogue with potential partners that in turn may lead to a collaboration/license agreement. We have already seen this autumn that our clinical status is attracting attention in the meetings we have had during various partnering and investor events. The trigger focus, as mentioned for interest, is at the PoC level even clearer than before.
Finally, what do you hope to report when you summarize 2024 in a year?
– That we are well on our way with our PoC studies with the goal of having identified suitable partners who can enter and continue the clinical development of Apta-1 towards market introduction. That we have also built a solid network of experts/KOLs in the therapeutic areas we are targeting. I also hope that we will have had a number of scientific publications approved and published, which is important for the academic and clinical spheres and not least for investors.
– I would also like to take this opportunity to wish everyone a very Merry Christmas and a Happy New Year! We are recharging our batteries over the holidays and will be back in January to take Apta-1 further through the clinical development phase towards a collaboration agreement for further development and commercialization.