Biotechs face upward battle with recruiting patients on obesity trials

02 May 2024
www.pharmaceutical-technology.com
Phase 2Phase 3
Biotechs face upward battle with recruiting patients on obesity trials
Preview
Source: Pharmaceutical Technology
Aphaia Pharma’s CEO Steffen Sebastian-Bolz discussed problems with obesity trial patient recruitment. Credit: Alexey Krukovsky via Getty Images,
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.
Free ReportHow is the Biopharmaceutical industry evolving?
2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape.
GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects.
Access the report to:
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Biotechs face upward battle with recruiting patients on obesity trials
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Biotechs face upward battle with recruiting patients on obesity trials
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Source: Pharmaceutical Technology
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Biotechs face upward battle with recruiting patients on obesity trials
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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.
See Also:Novo Nordisk aims for market domination, boasts $1.5bn obesity sales in Q1
Biotechs face upward battle with recruiting patients on obesity trials
Preview
Source: Pharmaceutical Technology
ePRO vs eCOA: Understanding the nuances in clinical trials
Biotechs face upward battle with recruiting patients on obesity trials
Preview
Source: Pharmaceutical Technology
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.
Free ReportHow is the Biopharmaceutical industry evolving?
2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape.
GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects.
Access the report to:
Benchmark the impact of major themes on the Biopharmaceutical industry.
Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents.
Evaluate the effects of COVID-19 on the sector.
Download the full report to understand what to expect and how to align your strategies for success.
By GlobalData
Biotechs face upward battle with recruiting patients on obesity trials
Preview
Source: Pharmaceutical Technology
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Mali (+223)
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Mongolia (+976)
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Saudi Arabia (+966)
Senegal (+221)
Serbia (+381)
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Singapore (+65)
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South Africa (+27)
Spain (+34)
Sri Lanka (+94)
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Sudan (+249)
Suriname (+597)
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Syria (+963)
Taiwan (+886)
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Thailand (+66)
Togo (+228)
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Trinidad & Tobago (+1868)
Tunisia (+216)
Turkey (+90)
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Tonga
Trinidad and Tobago
Tunisia
Turkey
Turkmenistan
Turks and Caicos Islands
Tuvalu
Uganda
Ukraine
United Arab Emirates
US Minor Outlying Islands
Uruguay
Uzbekistan
Vanuatu
Venezuela
Vietnam
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US Virgin Islands
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