Aptahem signs start up agreement with international clinical CRO for phase 1 studies with Apta-1
Aptahem (publ) announces today that the company has signed an agreement to initiate activities (Start Up Agreement, SUA) with the clinical contract research organization (CRO) The Centre for Human Drug Research (CHDR) in the Netherlands to prepare the upcoming phase 1 studies with Apta-1 and secure a timeslot to keep communicated timelines. As part of the SUA, CHDR will finalize the study protocol and prepare documentation to the authorities in collaboration with Aptahem.
Aptahem is developing Apta-1 as an acute treatment to prevent organ and tissue damages in patients with sepsis or other inflammatory critical conditions. Sepsis is a condition which yearly affects 47-50 million people worldwide, whereof approximately 11 million die. There is no effective treatment for sepsis and septic chock today, which indicates a large unmet medical need.
The drug candidate Apta-1 has in preclinical studies shown to counteract coagulation and reduce the risk of blood clotting, slow down the body’s uncontrolled inflammatory response, repair or inhibit tissue degradation and modulate the body’s own immune response. All of these mechanisms are relevant in the fight against sepsis, a multi factorial condition which can be triggered by several diseases and by a simple infection.
After the initial start up agreement the parties intend to sign a full agreement on performing the studies to keep the communicated timelines.
CEO Mikael Lindstam comments:
”After more than six months’ dialogue with CHDR we have now found a good design for the phase 1 studies with Apta-1 where we have discussed several topics, such as an added tailor made study design for Apta-1. Primarily we will study safety in healthy volunteers but also a first indication of the effect of Apta-1. The effect part of the study is important to confirm an initial Proof of Concept (PoC) and risk assess the protocol for the phase 2 studies. I am very pleased with this design and CHDR has been an excellent discussion partner in finding the optimal study design for Apta-1.”
For further information:
Aptahem AB
Mikael Lindstam, CEO
Tel: +46 (0)766-33 36 99
E-mail: ml@aptahem.com
About Sepsis
Sepsis is today considered a world health problem and affects 49 million people worldwide each year, of which 11 million die. In Europe alone, over 1 million people are estimated to be affected by sepsis on a yearly basis*. There is currently no specific treatment for sepsis, but instead the underlying symptoms are treated with antibiotics, fluids and oxygen.
* Rudd KE, Johnson SC, Agesa KM, Shackelford KA, Tsoi D, Kievlan DR, Colombara DV, Ikuta KS, Kissoon N, Finfer S, Fleischmann-Struzek C, Machado FR, Reinhart KK, Rowan K, Seymour CW, Watson RS, West TE, Marinho F, Hay SI, Lozano R, Lopez AD, Angus DC, Murray CJL, Naghavi M. Global, regional, and national sepsis incidence and mortality, 1990-2017: analysis for the Global Burden of Disease Study. Lancet. 2020 Jan 18;395(10219):200-211. doi: 10.1016/S0140-6736(19)32989-7. PMID: 31954465; PMCID: PMC6970225.
Forward-looking statements
This press release contains forward-looking statements that constitute subjective estimates and forecasts about the future. Assessments about the future are only valid on the date they are made and are, by their nature, similar to research and development work in the biotech field, associated with risk and uncertainty. In light of this, actual outcomes may differ substantially from what is described in this press release.
About Aptahem
Aptahem AB (APTA) is a biotechnology company that develops aptamer-based pharmaceuticals for the treatment of life-threatening conditions in which a combination of coagulation and inflammation are involved. The company’s primary pharmaceutical candidate, Apta-1, is being developed with the aim of preventing the high mortality rate caused by organ and tissue damage in sepsis patients, among others. The company possesses patent protection in strategic target markets and actively seeks business development opportunities with potential collaborators.