SK Biopharm acquires Parkinson disease drug candidate in deal worth $314.8 million

SK Biopharm has expanded its pipeline by acquiring a Parkinson disease treatment candidate from a South Korean biotechnology company.

According to U.S. biotechnology publication Fierce Biotech on the 17th local time, SK Biopharm signed a licensing agreement worth a total of $314.8 million with 1ST Biotherapeutics.

The agreement covers 1ST-104, an oral small-molecule compound being developed by 1ST Biotherapeutics. The compound is a dual inhibitor that simultaneously inhibits the LRRK2 and c-Abl enzymes, and is SK Biopharm’s second preclinical-stage Parkinson disease treatment.

1ST Biotherapeutics will receive an upfront payment of $1.8 million and a short-term payment of $1.8 million, as well as up to $314.8 million upon achieving development milestones. If 1ST-104 is commercialized, the company will also receive royalties. SK Biopharm will invest $2.2 million in an equity stake in the company.

Excessive activation of the LRRK2 enzyme inhibits the formation of cilia on the surface of brain cells. Cilia act as antennas that receive signals from the surrounding environment. Recent studies have suggested that inhibiting LRRK2 causes the cilia to regrow.

Neuron23 and Denali have LRRK2 inhibitor candidates in Phase 2 clinical development. However, Biogen withdrew from its co-development agreement with Denali in May after the program failed to meet its goals in a Phase 2 trial.

Some preclinical studies raised concerns that LRRK2 inhibitors could cause pathologic changes in lung tissue, but follow-up investigations found that the changes were temporary and not harmful.

1ST Biotherapeutics said it developed 1ST-104 as a type 2 LRRK2 inhibitor to address these limitations.

Jae-eun Kim, CEO of 1ST Biotherapeutics, said, "This agreement demonstrates our proprietary capabilities in next-generation target discovery and lead optimization."

Kim added, "It is an important milestone that combines our early research and development capabilities with SK Biopharm’s proven global development and commercialization expertise. We will leverage the strengths of both companies to advance the subsequent development of 1ST-104."

SK Biopharm currently markets the epilepsy treatment Xcopri and developed the narcolepsy treatment Sunosi. The company’s pipeline includes central nervous system disease treatments, including a preclinical-stage GCase activator for Parkinson disease.

Dong-hoon Lee, CEO of SK Biopharm, said, "The acquisition of 1ST-104 combines 1ST Biotherapeutics’ early discovery capabilities with SK Biopharm’s expertise in clinical development and commercialization. We will advance this candidate through successful clinical development and open new possibilities for Parkinson disease treatment."

Meanwhile, SK Biopharm’s most recent licensing agreement has encountered a setback. The U.S. Food and Drug Administration halted clinical trials last week for BHV-7000, an epilepsy treatment for which SK Biopharm paid an upfront payment of $350 million to secure worldwide rights.