Otsuka will gain Jnana’s lead candidate JNT-517 for treating phenylketonuria (PKU), along with its drug discovery RAPID chemoproteomics platform. Image Credit: Ratana21 / Shutterstock.

Otsuka Pharmaceutical is looking to acquire US-based Jnana Therapeutics in a deal worth up to approximately $1.1bn.

The Japanese company will pay Jnana’s shareholders $800m through its US subsidiary, Otsuka America. Jnana will also be in line to receive up to $325m in milestone-based payments. The deal is expected to close in Q3 this year.

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Otsuka plans for Jnana to operate as its subsidiary following the acquisition. To achieve this, it plans to merge Jnana with a special purpose company, established under Otsuka America, with the Jnana remaining as the surviving company.

Jnana’s lead asset is JNT-517 being developed to treat phenylketonuria (PKU), a rare inherited metabolic disorder that causes an amino acid called phenylalanine to build up in the body. JNT-517 inhibits SLC6A19 or solute carrier family 6 member 19, a transmembrane protein that regulates phenylalanine absorption and reuptake in the small intestine and kidney.

In June, Jnana reported positive topline data from a Phase I trial (NCT05781399) evaluating JNT-517 in 64 healthy individuals. The therapy was safe and well tolerated at all dose levels, with no serious adverse events. The company plans to start a registrational trial for JNT-517 next year.

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The deal will also give Otsuka access to Jnana’s drug discovery technology, the RAPID chemoproteomics platform. The platform has been successful in identifying therapies against various cancers, and immune-mediated and neurological targets, with Jnana signing two drug discovery deals with Roche.

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There are a limited number of therapies in development to treat PKU. PTC Therapeutics has found success with sepiapterin, which was studied in a positive Phase III AFFINITY trial (NCT06302348). The placebo-controlled portion of the study included 98 patients with PKU who achieved a mean phenylalanine reduction of 63% when treated with sepiapterin.

However, this area has also seen some disappointments. Synlogic was not that successful with its PKU therapy SYNB1934, which was designed to reduce phenylalanine levels in the gastrointestinal (GI) tract. In February, Synlogic had to terminate SYNB1934’s development after an interim data review found that the Phase III Synpheny-3 trial (NCT05764239) was unlikely to meet the primary endpoint. Following that news, the company laid off more than 90% of its staff.