Continued Good Tolerability of NEX-22 at 30 mg Dose of Liraglutide in the NEX-22 Study
Nanexa AB announces that initial observations in the phase I study show that the 30 mg dose of NEX-22, a depot formulation of liraglutide, has been well tolerated by patients with type 2 diabetes who have not previously received GLP-1 treatment.
A disadvantage of liraglutide given as daily injections is a high incidence of early gastrointestinal side effects such as nausea and diarrhea, and requires a cautious dose escalation to an effective daily dose (1.2 mg). After an injection of NEX-22 with 30 mg liraglutide released over a month, no nausea, vomiting or diarrhea was observed in the three patients dosed.
Two patients experienced decreased appetite, one of them in combination with heartburn. All observations were mild and transient and are also commonly seen with GLP-1 treatment. Observations at the injection site also show that the 30 mg dose has been well tolerated, with only limited skin reactions of minor and transient nature.
"These are very positive results!" says David Westberg, CEO of Nanexa. " The fact that NEX-22 can be administered at a dose of 30 mg liraglutide without causing nausea, vomiting, and diarrhea, which are all common gastrointestinal side effects associated with GLP-1s, shows great potential benefits. We look forward to further presenting all the results from the study."
The follow-up of patients continues to monitor the concentration of liraglutide in the blood just over a month, along with evaluation of safety and tolerability.