Months later, LogicBio exits FDA clinical hold for gene editing drug but won't restart trial until next quarter
LogicBio Therapeutics has received some good news this morning as the FDA has lifted a three-month clinical hold on one of the company’s primary trials for a potential gene editing drug, but the trial isn’t expected to resume until next quarter.
Enrollment in the Phase I/II trial, dubbed SUNRISE, for LogicBio’s gene editing therapy LB-001 will be allowed to resume. The trial is focused on pediatric patients with methylmalonic acidemia, or MMA, an inherited disorder in which the body is unable to process certain proteins and lipids properly.
The agency had initially placed a clinical hold on the AAV-delivered therapy in February of 2022 after two adolescent patients in an early trial for the drug were diagnosed with thrombotic microangiopathy (TMA), a clinical syndrome defined by the formation of tiny clots in blood vessels.
In its letter, according to the company, the FDA acknowledged that LogicBio had satisfactorily addressed all the issues surrounding the hold.
“We are pleased that the FDA has completed its review of the information we provided and that the hold on our LB-001 IND has been lifted,” Frederic Chereau, president and CEO of LogicBio, said in a statement. “We look forward to dosing the next patient in our SUNRISE trial, which we expect will occur in the third quarter of 2022.”
According to LogicBio, the company amended its protocol reflecting dialogue with the FDA, and is now planning to go ahead with dosing after it implements the necessary changes, including enhanced monitoring measures such as frequent testing for complement activation, a characteristic of TMA.
The company also stated that it is reinstating its previous guidance and expects interim data later this quarter.
The genetic medicine company has hit some major speed bumps related to LB-001. Apart from the hold in 2022, the company was also slapped with a clinical hold on the program in February 2020, as it began tests in humans.
As LogicBio plans to put the FDA holds in its rearview mirror, it still has several challenges as the current bear market has cast a long shadow over the industry.
While LogicBio’s stock price rose by 60% in early morning trading on Monday, the price $LOGC is down almost 70% year to date.