CinFina Pharma has commenced the Phase I multiple-ascending dose (MAD) clinical trial of CIN-110 to treat obesity.
The placebo-controlled, randomised trial will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of CIN-110 in adult subjects with obesity.
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It will be offered subcutaneously (SC) in trial subjects with obesity aged 18-55 years, with a body mass index between 30 and 44.9kg/m² over 12 weeks.
The study will have multiple cohorts with 12 subjects each, who will be randomised into a 3:1 ratio to receive either SC CIN-110 or a placebo, respectively.
The commencement of the MAD trial comes after the launch of an ongoing SAD [single-ascending dose] study, in which CIN-110 was demonstrated to be well-tolerated.
In the SAD trial, the treatment was also shown to offer a decline in caloric intake and body weight.
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By GlobalDataCinFina Pharma noted that the data from the SAD trial will inform the dosing regimens in the MAD study.
In March this year, the company received clearance for the investigational new drug application (IND) from the US Food and Drug Administration (FDA) to commence the study of CIN-110 for obesity.
CinRx Pharma chief translational science officer Mary Bond said: “To date, CIN-110 has demonstrated very strong safety and pharmacokinetic profiles in its single-dose study, as well as encouraging pharmacodynamic data.
“We are excited to see this promising asset advance into this next clinical assessment, where we will gain an even greater understanding of its potential to provide a safe and effective obesity treatment option for physicians and their patients.”
CIN-110 is a new PYY₃₋₃₆ analogue, claimed to have a longer half-life. The treatment also has the potential to be long-lasting and well-tolerated, without causing nausea and emesis linked to PYY-focused therapies.
