Following plans to add cohorts in an ongoing Phase II weight-loss study, Aphaia Pharma’s CSO Steffen-Sebastian Bolz says there are now rising challenges with the recruitment of patients in obesity trials.
As per a 25 April press release, Aphaia Pharma has begun recruitment for four more cohorts in its weight-loss trial, investigating two formulations— 6g (APHD-006) and 8g (APHD-008)— of its therapy APDH-012. Bolz anticipates topline data in October.
“It has become increasingly difficult to recruit patients because the [weight loss] space is absolutely crowded,” says Bolz. He explains that with the boom in obesity therapeutic development, pharmaceutical companies are running more and more clinical trials that extend past the usual Phase III programmes. He also highlights trials designed to evaluate cardiovascular risk as examples of this.
Bolz says there is a “large discrepancy” between trial recruitment for large pharmaceutical companies and small biotech companies, as the financial incentives to participate in such trials can vary massively. Furthermore, obesity is a condition that has fewer official patient organisations than other medical conditions that can often be a useful resource for patient recruitment, he adds. Aphaia has just successfully completed recruitment for the first two cohorts of its weight loss study.
In the last few years, the US Food and Drug Administration (FDA) has approved several therapies for weight loss and diabetes, including Eli Lilly’s Zepbound (tirzepatide) and Novo Nordisk’s Wegovy (semaglutide). Thus far, Eli Lilly has published data from eight studies investigating tirzepatide for obesity and type 2 diabetes, but the company has plans to release data from several ongoing and upcoming studies in the next few years.
Bolz says that Aphaia Pharma has not had trouble with recruitment due to its drug’s unique mechanism of action, which leads to very few side effects. APHD-012 gives a targeted release of glucose that restores endogenous nutrient-sensing signalling pathways and triggers the release of enteric hormones related to the systems for appetite, hunger, satiety, glucose metabolism, and energy expenditure. This includes hormones such as glucagon-like peptide 1 (GLP-1), peptide tyrosine-tyrosine (PYY), glicentin and oxyntomodulin (OXM).
Furthermore, Bolz highlighted the company’s efforts to form a tight relationship with its CRO partners and medical centres, enabling Aphaia to reach out to patients through its partners’ networks. He adds that through this method, centres can also forward essential drug information to the patients, increasing compliance.
The oral therapy is currently being assessed in a Phase II weight-loss trial (NCT05385978) and a Phase II prevention trial for prediabetic patients (NCT05803772). The Swiss biotech is developing and investigating the therapy in the US, Canada, Puerto Rico, Germany, and the country of Georgia.
