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More than ever, sustainable health care requires cooperation between pharmaceutical research, medical technology, and specialist mechanical engineering. The project surrounding the ACESO study shows how this partnership leads to success right from the start. And even brings the targeted treatment of esophageal cancer within reach.

Around 370 million people worldwide suffer from diseases of the upper digestive tract: from eosinophilic esophagitis to reflux disease and Barrett’s syndrome to dangerous esophageal cancer. * Such conditions pose a challenge in medicine, as local treatment has not been possible to date.

“The fundamental problem lies in the short transit times of only a few seconds from the mouth to the stomach, which make local treatment more difficult,” explains Dr. Peter Stangier, Director Strategic Planning at the Swiss biotech company EsoCap. “Systemic treatment is in turn associated with toxic stress and possible restrictions in quality of life. Our vision, on the other hand, is to improve the lives of patients with severe esophageal diseases through targeted local and long-lasting treatments. And we have developed a unique form of administration for this purpose.”

ACESO – the goddess of healing

The administration system is ingenious: It consists of a capsule holder and a hard gelatine capsule containing a thin film with an active pharmaceutical ingredient. When the capsule is drunk from a special drinking cup, the film unrolls and adheres to the mucous membrane of the esophagus, where it slowly dissolves and continuously releases the active ingredient. The technology offers maximum flexibility, as several relevant active ingredients can be integrated in the thin film, including biologicals and other innovative compounds.

Developed in collaboration with the University of Greifswald, the system has already proven itself in the first two phases of clinical development. Initially, tests were carried out on healthy volunteers and analyzed using magnetic resonance imaging. The images confirmed that the film unrolled well and adhered to the esophagus for at least 15 minutes. Swallowing the capsules on consecutive days was also accepted by the participants without any adverse effects. This was followed by a proof-of-concept Phase II study of patients suffering from eosinophilic esophagitis. The placebo-controlled study was named after Aceso, the Greek goddess of the healing process. It used the active ingredient mometasone furoate, which was administered to 43 patients in five countries using EsoCap technology. A statistically significant superiority of the drug over the placebo was confirmed. “The ACESO study confirms that our technology delivers medication to the mucous membrane of the esophagus, directly and effectively, which makes a noticeable difference in treatment,” claims Stangier.

Placebos by weight

For the capsule to be easy to swallow, another crucial element was needed: a placebo tablet inside the capsule to provide the requisite weight and thus ensure that the capsule could be swallowed easily. EsoCap started looking for a reliable partner. Stangier remembers: “We were aware of Fette Compacting as a leading company in the area of tableting. So, we got in touch with the aim of working together to design a high-density placebo. It had to be made of heavy materials and make the best possible use of the limited space available inside the capsule. Together with the experts at Fette Compacting, we succeeded in making the delivery system easier for patients to swallow and it sinks easily into the gastric fluid once the active ingredient has been released.”

“We took on the order with great passion because we saw a huge potential to improve patients’ quality of life,” reports Dr. Anna Novikova, Head of Process Consultancy at Fette Compacting. “The challenge was to optimize the placebo developed by EsoCap in such a way that it imitated the outlines of the capsule. In order to fill all the free spaces, it also had to have certain curves. At the same time, the material had to be pressed under maximum pressure in order to achieve the highest possible density. This resulted in special requirements for the process and the design, as well as the ensuing load limit of the tableting tools.”

Step by step to the best design

The team arrived at the optimum design in a multi-stage and creative process in which application experts from Fette Compacting collaborated with colleagues from the Tableting Tools business unit. “We started with a cylinder, then the shapes became a little more exotic and ultimately, the curved oblong tablet proved successful,” summarizes Novikova. “In the end and with our support, EsoCap has not just designed a tablet, but actually improved the swallowability of the capsule to ensure easy and reliable use. With a view to later production, we were also looking for a design that could be implemented easily and efficiently on the machine without requiring any special solutions. This reduces the production costs, which can have a significant influence on the price of the medication and access for patients.”

Thanks to the convincing results of the ACESO study, the next steps have already been determined: several discussions with the regulatory authorities in the United States and Europe to initiate a phase 2b/3 study for approval as soon as possible. On this path, Stangier continues to rely on the partnership with Fette Compacting and is completely satisfied: “We will work together to further increase the tablet weight. It is not always easy for a start-up to gain the support of renowned companies in research and development. Against this backdrop, our collaboration with Fette Compacting has been an extremely positive experience for us. Exchanges were very open right from the start, always with goal-oriented solutions and clearly identified limits. Enabling us to make a confident decision for the system design.”