Otsuka acquires Jnana's phenylketonuria drug for $800m

Otsuka Pharmaceutical is poised to acquire Jnana Therapeutics, an American biotech firm, in a transaction valued at approximately $1.1 billion. This acquisition plan involves an $800 million payment to Jnana’s shareholders through Otsuka's US subsidiary, Otsuka America. Additionally, Jnana stands to gain up to $325 million in milestone-based payments. The deal is projected to be finalized in the third quarter of this year.

Once the acquisition is complete, Jnana will operate as a subsidiary of Otsuka. To facilitate this transition, Otsuka intends to merge Jnana with a special purpose company created under Otsuka America, with Jnana remaining as the surviving entity.

The focal point of Jnana’s development pipeline is JNT-517, a promising candidate for treating phenylketonuria (PKU). PKU is a rare genetic metabolic disorder that leads to the accumulation of phenylalanine, an amino acid, in the body. JNT-517 functions by inhibiting SLC6A19, a transmembrane protein that plays a crucial role in the absorption and reuptake of phenylalanine in the small intestine and kidneys.

In June, Jnana announced encouraging topline results from a Phase I clinical trial (NCT05781399) involving 64 healthy participants. The findings indicated that JNT-517 was safe and well-tolerated across all tested dose levels, with no serious adverse events reported. Building on this success, the company plans to commence a registrational trial for JNT-517 in the upcoming year.

In addition to JNT-517, the acquisition will provide Otsuka with access to Jnana’s innovative drug discovery technology, the RAPID chemoproteomics platform. This platform has demonstrated efficacy in identifying therapeutic candidates across various diseases, including cancer, immune-mediated conditions, and neurological disorders. Jnana has also established drug discovery collaborations with Roche using this technology.

The landscape for PKU treatments has seen limited therapeutic options in development. One notable success is PTC Therapeutics' sepiapterin, which showed positive outcomes in the Phase III AFFINITY trial (NCT06302348). In this placebo-controlled study, 98 PKU patients experienced an average phenylalanine reduction of 63% with sepiapterin treatment.

However, not all efforts in PKU treatment have been fruitful. Synlogic's PKU therapy, SYNB1934, aimed to reduce phenylalanine levels in the gastrointestinal tract but did not meet expectations. In February, an interim data review of the Phase III Synpheny-3 trial (NCT05764239) suggested that the primary endpoint was unlikely to be met, leading to the termination of SYNB1934's development and significant staff layoffs at Synlogic.

By acquiring Jnana Therapeutics, Otsuka Pharmaceutical aims to expand its capabilities in drug development, particularly in the niche area of PKU treatment, and leverage Jnana’s advanced chemoproteomics platform for broader therapeutic applications.

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