Freeline Therapeutics Holdings (NASDAQ: FRLN) dosed its first patient in a Phase I/II in a trial for FLT180a. This therapy is to treat hemophilia B. The disease is characterized by a lack of Factor IX, a protein essential for clothing. It results in excessive bleeding.
The treatment works by delivering a version of factor IX through adenovirus vector capsid. This process facilitates the normal formation of blood clots.
According to Freeline’s Chief Medical Officer, Dr. Pamela Foulds, the company believes that combining a small dose of the adenovirus capsid and a regimen of immune management will help patients with hemophilia B attain and maintain the typical factor IX range.
The company’s CEO Michael Parini adds that the company is happy about the progress it has attained in the advancement of FTL180a as it is paying dividends to open up its clinical programs’ value. Moreover, the company has dosed its first patient in the U.S, underscoring its dedication to expand its footprint and strengthen its programs.
The company plans to finish the study in 2022
Parini states that the company already has enough patients with hemophilia B to enroll in its B-LIEVE study. These patients will come from its ECLIPSE study. Furthermore, the company hopes to finish dosing its first cohort and release results from the study in a few months.
In case the company decides to dose more patients for the first cohort or dose a second cohort, it will release the results of the study in Q3, 2022. It will also release biomarker and safety data in 2022 and 2023.
Parini states that these moves make up part of Freeline’s milestones as it heads towards a Phase III study. The company expects to start activities related to the study in 2023.
The company hopes to conclude on a dose
The initial dose for FTL189a in the Phase I/II trial is 7.7e11 VG/kg. The company came up with this dose after making multiple models and through results from its B-AMAZE trial. Through the new B-LIEVE study, the company hopes to find the most appropriate dose. This data is essential for the Phase III trial where Freeline wants to FIX expression consistently in hemophilia B patients.
Freeline Therapeutics is a biotechnology company that focuses on developing one-time therapies for genetic diseases.
