Biotechnology company Herantis Pharma reports that it has successfully completed the first part of the phase 1b clinical trial of the drug HER-096.
The HER-096 drug is being developed for the treatment of Parkinson’s disease.
According to the company’s press release, the Data and Safety Monitoring Board has decided that the study can now continue into its second part with a maximum of 28 patients with Parkinson’s disease. The recruitment of patients for the second phase has started.
Eight healthy volunteers participated in the phase that has now ended.
According to the company’s press release, in the first part of phase 1b, it was found that the pharmacokinetic profile of HER-096 in both blood and cerebrospinal fluid was as expected and corresponded to previous clinical results. The safety profile was also in line with expectations and corresponded to previous clinical results.
The phase 1b clinical trial has two parts.
In the just-completed first part of the study, subjects were administered a single subcutaneous dose of 300 mg of the investigational drug HER-096 to evaluate its safety and pharmacokinetic properties.
In the second part of the study, patients will receive 200 mg or 300 mg doses of HER-096 investigational drug or placebo twice weekly for four weeks to evaluate the safety, tolerability and pharmacokinetics of repeated subcutaneous doses of HER-096.
The goal is also to evaluate pre-selected biomarkers and to find and identify new biomarkers in patients with Parkinson’s disease.