Passage Bio, which has been working toward a registrational trial for a drug candidate whose indications include frontotemporal dementia, is exploring strategic alternatives in addition to cutting staff.
Shortly after announcing that the FDA will require a specific registrational trial design for its lead drug candidate in one target indication, Passage Bio has disclosed it will cut about 75% of its workforce to reduce operating expenses. The Philadelphia-based biotech had 24 employees as of Dec. 31, according to an annual report, meaning the layoffs could affect around 18 people.
Passage, which focuses on developing genetic medicines to treat neurodegenerative diseases, expects to mostly complete the workforce reduction in the second and third quarters, according to an April 28 SEC filing. The biotech projects severance and exit costs will be about $3.3 million.
On April 20, Passage announced the outcome of a recent Type C meeting with the FDA regarding design of a future registrational trial for PBFT02 for the treatment of frontotemporal dementia with granulin mutations (FTD-GRN). Will Chou, the company’s president and CEO, said the agency did not support a single-arm trial design and instead will require a randomized controlled trial.
“In light of this outcome and the associated ethical, logistical, and financial challenges, we are currently evaluating potential next steps for the PBFT02 clinical development program and for the company,” he said in the announcement.
The company noted that to maximize shareholder value, it is exploring strategic alternatives that could include a merger or acquisition, a sale of assets and licensing opportunities.
Passage did report some positive news on April 20. Chou shared that data from an ongoing Phase 1/2 upliFT-D clinical trial evaluating PBFT02 for FTD-GRN showed that the drug may slow neurodegeneration in patients with the disease. He noted improvements in brain atrophy and plasma neurofilament levels, two biomarkers of disease progression. Chou added that the company continues to see “durable and robust” elevations in progranulin, the target protein, and is encouraged by emerging data indicating that a lower dose level can achieve similar progranulin expression as a higher dose.
According to its annual report, Passage had cash and cash equivalents of $46.3 million as of Dec. 31, which it expected would fund the business into Q1 2027. That figure was down from the $52.8 million the company had reported for the quarter ending Sept. 30.
