Nearly out of cash, a former Sarepta partner asks French courts to oversee restructuring
Lysogene is teetering on the edge.
The Paris biotech requested the country’s government open what’s known as a “safeguard proceeding” on Tuesday, a legal maneuver amounting to a corporate restructuring overseen by a judge. A decision about how Lysogene shall move forward is expected next week, and the company has requested a stock halt while the French court deliberates.
Tuesday’s move comes after Lysogene’s gene therapy for Sanfilippo syndrome type A, or MPS IIIA, flunked a PhII/III study last month when it whiffed on improving cognitive development in patients older than 30 months. The biotech stock has been down more than 66% this year on the Euronext Paris exchange before Tuesday’s halt.
In order to move forward, Lysogene will likely have to sell some assets or find a partner — or both. Currently, execs only guide its cash runway to next February, and a Tuesday press release noted they are already searching for business partners.
The gene therapy that failed, known as LYS-SAF302, didn’t hit any of the key secondary endpoints on top of the primary miss. But Lysogene pointed to a possible path for LYS-SAF302 by touting an “ancillary cohort” of six young patients who were enrolled before they reached 30 months, where they saw improved cognitive development after two years.
If Lysogene can find the money for it, that’s likely where execs will push the drug’s advancement.
Lysogene’s gene therapy has faced doubts before, as in June 2020, when the FDA placed the program on a clinical hold. Four months later, the biotech announced that a child who took the treatment had died. Lysogene had previously been partnered with Sarepta, but they walked away earlier this year after committing $15 million upfront in 2018.
Other assets include an early-stage gene therapy for GM1 gangliosidosis and a license with the Weizmann Institute of Science for a Parkinson’s disease gene therapy candidate.
