Business Idea & Technology:
Akesion GmbH develops a novel therapeutic agent, AK03, for the prophylaxis of peritoneal adhesions. Adhesion formation represents a frequent and potentially severe complication caused by local irritation, mechanical trauma and ischemia. Peritoneal adhesions are occurring after more than 50% of lower abdominal surgeries and may result in female infertility, chronic pain, or life threatening bowel obstruction. Almost every third patient is readmitted with adhesion-related complications within ten years and one out of 10 patients requires emergency surgery for a life-threatening bowel obstruction.
Clinically symptomatic adhesions can only be treated by subsequent re-operation (adhesiolysis). Currently available prophylactic agents are solid barriers or liquids to physically separate organs during the initial process of wound healing. Due to their poor efficacy and their difficult handling these devices are rarely used and mostly not reimbursed.
AK03 is a novel fusion protein, consisting of a fibrinogenolytic enzyme moiety linked to the human IgG1 constant region. AK03 was designed for longer retention in the peritoneum (site of action) and reduced systemic availability (potential for side effects). By locally removing fibrinogen in the peritoneal cavity, AK03 effectively prevents the formation of irreversible tissue connections. In an established and validated rat model, AK03 reduced the formation of adhesions by more than 50%. No systemic side effects and no adverse effects on wound healing were observed in rats and pigs. The liquid formulation of AK03 allows for simple administration both after open surgeries (laparotomy) as well as minimally invasive surgery (laparoscopy).
As first effective agent with a pharmacological mode of action, AK03 has the potential for fundamentally changing the paradigm for the prevention of postsurgical adhesions.
Business Model and Market Strategy:
Akesion GmbH operates as a virtual “project company” in which all strategic activities are coordinated in-house. Operative tasks are contracted to partners and vendors. Akesion intends to maintain a lean and effective workforce. Up to now the rights to develop AK03 are solely owned by Akesion without any obligations for royalties to third parties. The goal is to partner or license AK03 to pharmaceutical companies. This is expected after reaching clinical “proof-of-concept” at the latest.
Due to the high medical need to prevent adhesions and the chance to develop the first drug which is approved for prevention of adhesions, the market potential is significant and can reach block buster potential easily. In addition, AK03 may be used in other indications with a high medical need as well.
AK03 and related substances are protected by an international patent application submitted in 2014. The applications entered the national phases in 2017. The strong IP position will be further strengthened by the following development steps such as production, clinical studies and regulatory approval.
Akesion GmbH was founded in January 2014 by Stephan Witte and Klaus Rübsamen. Both founders have profound experience in drug development from discovery, clinical development, until regulatory approval. They worked in international companies and for small biotech startups. Their motivation to further develop AK03 results from the promising preclinical data based on a defined and validated pharmacological mode of action, the high market potential, a high unmet medical need and, at present, no competing developments or products.
AK03 is expressed and purified by an external partner per Akesion’s specifications. The pharmacological properties were evaluated in animal experiments conducted by external laboratories and researchers of the university clinic of the RWTH Aachen. In the Science4Life business plan competition, Akesion was the only team among the finalists in all three stages of the competition. Protein manufacturing and animal studies were financed by private funds. Currently, Akesion is planning for the GMP production of AK03 and the regulatory studies necessary for obtaining permission for administration to humans. Due to its pharmacological mode of action the development of AK03 follows the regulations for drugs.
Opportunity for Investments and Cooperation:
AK03 has the potential to cause a paradigm shift in the prophylaxis of postsurgical adhesions. The goal is to develop AK03 till proof of concept in humans which will allow to sell or to license out to pharma companies for the clinical development. Given the significant market potential of AK03, a possible exit should secure adequate return of investment for all possible investors and owners. The capital requirement for preclinical development until submission of a clinical trial authorization/IND in 2020 is 4.5 million EUR. The costs for the first clinical trial in 2020-2022 are estimated as 4-6 million EUR.