Since 2019, Aptahem has collaborated with the Cardiovascular Research Centre (CVRC) at Örebro University to better understand certain mechanisms behind Apta-1’s effect. Now the collaboration has borne fruit by identifying and clarifying a mechanism of action for the drug candidate Apta-1. BioStock contacted Luiza Jedlina, CSO at Aptahem, to find out more about what this means for Aptahem.
Biotech company Aptahem develops pharmaceuticals for the treatment of severe conditions where coagulation and inflammation are key components. The company’s leading candidate is Apta-1, an emergency drug for the treatment of sepsis.
Now the company’s partner Cardiovascular Research Centre (CVRC) at Örebro University has identified a pharmacological mechanism of action for Apta-1 down to a molecular level. The results are important for Aptahem from a regulatory perspective and in order to be able to enter clinical phase. A scientifically proven mechanism of action is necessary to obtain final approval by the national authorities.
Cardiovascular Research Centre (CVRC)
CVRC is a research environment founded in 2014 at Örebro University. The network consists of about 30researchers at the university and Region Örebro who work with research to identify disease mechanisms, more effective diagnosis, treatment and prevention of cardiovascular diseases.
With financial support from the Knowledge Foundation’s Prospect Call, CVRC has now produced resultsthat clarifies one of Apta-1’s mechanisms. The research results will be tested for publication in a scientificjournal, and then more information will be given to the public. In a press release, Aptahem’s CSO Luiza Jedlina expressed the company’s excitement over the announcement:
»We are very excited over the recent results presented to us by the group in Örebro, and we have had several discussions to ensure that we fully understand what these findings mean.« — Luiza Jedlina, CSO and co-founder of Aptahem
More good news for Apta-1
It is also worth noting here that the identified mechanism of action is not the only good news to come from the Apta1 project recently. Yesterday, Aptahem announced that it had received a preliminary approval (Notice of Allowance) from the US Patent Office for their patent family 2, which covers therapeutic protection of Apta-1. Upon official approval, the patent will be valid until 2037 and will mean important protection for Apta-1 on one of the largest markets in the world.
Luiza Jedlina comments
BioStock contacted Luiza Jedlina to learn more about the significance of the results and what the company’sfuture plans for Apta-1 look like.
Can you tell us a bit more about the results that CVRC has generated?
– At the moment we cannot disclose more info than we have as we are now preparing to submit these results and other supporting data from earlier studies performed by Aptahem for publication.
– Anyway, to define a mechanism on a molecular/intracellular level is of course of great impact and the results has been a confirmation of my envisioned idea that led to the start of the company. This vision was carried into the design of previous in-vivo studies when working with the understanding of our early results within coagulation and Apta-1’s ability to act as anti-coagulant with none of the regular side effects. The collaboration and results from CVRC have placed an important piece of puzzle to clarify my understanding and beautifully confirm this.
How important are these research results for the company?
– Very important, as the complexity of the unique multi mechanism has kind of been hidden or shadowed by itself and has thus taken long time to untangle but with the superb competence of the Örebro team we definitely speeded up this process. These results confirm our in-vivo results more accurately and clarifies a major pathway of Apta-1’s effect.
– The importance is that we now have a clearer regulatory portfolio for Apta-1.
Since you are one of the co-founders of Aptahem, you have been a part of the company since the beginning. Would you say that this is one of the biggest achieved milestones for Aptahem so far?
– I think we had many great milestones since the start of the company if you consider the complexity of Apta-1 and its multi mechanistic behavior. However, science and regulatory wise it is very important and we should not forget that potential partner candidates will appreciate this as such knowledge is very important for them.
With one of the mechanisms of action found for Apta-1, what does the development plan look like for the drug candidate?
– We will continue according to our scientific plans and our program towards the clinic. Of course, we will keep on nurturing our collaborations and push our inhouse efforts to seek further proof and clarification on Apta-1’s amazing abilities.
Now that you can enter the summer with this encouraging news under your belt, what can we look forward to from Aptahem for the rest of 2021?
– To finalise our pre-clinic GLP-tox, GMP manufacturing, formulation and regulatory package so we can enter the clinic. We are of course not intending to rest on our laurels now, instead the scientific programmes and the preparations for scientific publications continue. Finally, one must not forget that the clarified mechanism adds value to Aptahem and will strenghten our business development efforts.
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