SK Biopharmaceuticals adds Parkinson’s disease drug to pipeline in US$315M deal

Under the agreement, 1ST Biotherapeutics will receive US$1.8 million upfront and an additional US$1.8 million payment in the near term.

SOUTH KOREA—SK Biopharmaceuticals has expanded its Parkinson’s disease drug pipeline through a licensing agreement worth up to US$314.8 million with fellow South Korean biotech company 1ST Biotherapeutics.

The deal covers 1ST-104, an oral small molecule that targets two enzymes, LRRK2 and c-Abl, and is currently in preclinical development.

Under the agreement, 1ST Biotherapeutics will receive US$1.8 million upfront and an additional US$1.8 million payment in the near term.

The company could also receive milestone payments that would bring the total deal value to US$314.8 million, alongside royalties on future sales if the drug reaches the market.

Separately, SK Biopharmaceuticals will invest US$2.2 million in 1ST Biotherapeutics through an equity investment.

Targeting LRRK2 in Parkinson ’s disease

The drug targets LRRK2, an enzyme linked to Parkinson’s disease. Excessive LRRK2 activity can interfere with the formation of tiny, hair-like structures called cilia on brain cells.

These structures act like antennae, helping cells receive signals from their surroundings.

Research has increasingly suggested that inhibiting LRRK2 can help restore cilia formation, making the enzyme a focus of Parkinson’s disease drug development.

Several companies are pursuing this approach.

Neuron23 has an LRRK2 inhibitor in Phase 2 development, while Denali Therapeutics is also advancing a candidate in mid-stage development.

However, Biogen withdrew from its partnership with Denali after their LRRK2 inhibitor failed to meet its primary endpoint in a Phase 2 trial in May.

Safety concerns have also emerged. Preclinical studies have linked LRRK2 inhibitors to histopathological changes in the lungs.

However, follow-up investigations have suggested that these changes may be temporary and do not necessarily cause lasting harm.

1ST Biotherapeutics said it developed 1ST-104 as a Type 2 LRRK2 inhibitor to address limitations associated with existing approaches.

Companies combine research and development expertise

In a September 17 statement, 1ST Biotherapeutics CEO Jamie Jae Eun Kim said the agreement validated the company’s drug discovery capabilities, particularly its work on identifying new targets and optimizing drug candidates.

Kim said the partnership would combine 1ST Biotherapeutics’ early-stage research and development expertise with SK Biopharmaceuticals’ experience in global drug development and commercialization.

SK Biopharmaceuticals currently markets Xcopri, a treatment for epilepsy, and developed Sunosi, a medicine used to treat excessive daytime sleepiness.

Its research pipeline also includes a glucocerebrosidase (GCase) activator in preclinical development for Parkinson’s disease.

SK CEO Donghoon Lee said the agreement would help the companies advance 1ST-104 toward clinical development and explore new treatment possibilities for Parkinson’s disease.

Recent licensing deal faces regulatory setback

The agreement follows another major licensing deal by SK Biopharmaceuticals, which paid US$350 million upfront last week for worldwide rights to BHV-7000, an investigational epilepsy drug that selectively activates Kv7.2 and Kv7.3 potassium channels.

However, the US Food and Drug Administration subsequently placed clinical trials of BHV-7000 on hold, creating a regulatory setback for the recently licensed candidate.

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