Freeline Therapeutics Holdings (NASDAQ: FRLN) has updated its FLT190 timelines and plans for clinical development. The therapy treats Fabry’s disease. Fairy is a genetic disorder that disrupts the standard storage in lysosomes. It results in organ dysfunction and cell abnormalities of tiny blood vessels, the CNS, heart, kidneys, and the skin.
Freeline will not add a third patient to its dose-escalation phase
As per the announcement, the company is moving to a second dose cohort in the escalation study. It intends to dose its first patients in the middle of the year. Moreover, it has altered its plans to administer the drug to another patient for the first dose cohort after evaluating the safety and clinical efficacy data review for its first two patients.
As per the data review, Freeline Therapeutics reported its findings to the DMC (Data Monitoring Committee). The body supports the company’s decision to proceed to the next cohort.
According to Freeline Therapeutics’ Chief Medical Officer, Pamela Foulds, the company decided not to dose an extra patient for its first dose cohort after consistent results on its efficacy and safety. Approval from regulatory bodies and the DMC also encouraged this decision.
Freeline is now considering that it could accelerate dosing if it receives positive results from its next patient. These moves will enable the company to finish developing and commercializing the drug and help people with Fabry.
The company hopes to improve the lives of patients with Fabry
Freeline’s CEO, Michael Parini, adds that the company has had a strong foundation in this clinical trial which could translate into a life-changing therapy for patients with Fabry disease. He adds that Dr. Foulds’ leadership in the FLT190 study slogans with the company’s goals of unlocking the treatment’s value.
Freeline Therapeutics will update shareholders on its progress with the therapy later in the year. Moreover, it will release its financial statement and discuss other business updates.
Freeline is a biotechnology company focused on developing systemic vector-mediated adenovirus-associated gene therapies. It uses its medicines to treat debilitating genetic diseases. Its treatment works after one dose.
Freeline Therapeutics is now working on treatments for Gaucher type 1 disease, Fabry disease, and Hemophilia B. Furthermore, the company has operations in the U.S and Germany and headquarters in the U.K.