Terran Biosciences is waiting for KarXT to receive approval from the FDA before initiation two Phase I trials of its prodrug TerXT. Image credit: New Africa / Shutterstock.

Terran Biosciences is aiming to launch two Phase I trials of its candidate TerXT for patients with schizophrenia.

Terran Biosciences CEO Sam Clark told the Clinical Trials Arena that TerXT is a long-acting pro-drug of Bristol Myers Squibb’s (BMS) KarXT, a combination of xanomeline and trospium.

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KarXT was originally developed by Karuna Therapeutics until BMS acquired the company in a $14bn deal.

KarXT is yet to be approved by the US Food and Drug Administration (FDA) but a PDUFA date is set for 26 September. The therapy is the first potential new pharmacological approach for treating schizophrenia in over 50 years.

TerXT is a once-daily oral candidate while TerXT LAI is a multi-month injectable candidate. Both use the same candidates as KarXT, which is a twice-daily oral drug, but is longer-acting.

Terran is looking to launch two Phase I trials soon, one for each of the candidates to confirm safety and pharmacokinetics, with Clark adding that due to the regulatory pathway the company is utilising, they will plan to meet with the FDA prior to study start to align on the studies required.

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Each trial plans to enrol approximately 100 participants, but Clark said it is yet to be confirmed with the FDA whether these will be healthy volunteers or patients with schizophrenia.

New York-based Terran will then be looking to file a rapid 505(b)(2) approval pathway for TerXT and TerXT LAI once BMS’s five-year exclusivity period has elapsed.

The 505(b)(2) pathway is for new chemical or molecular entities or for candidates that involve changes made to previously approved drugs. The NDAs for this pathway can contain safety and effectiveness data from studies that the applicant may not have run, with Terran planning to use data from BMS’ Phase III trials of KarXT.

Schizophrenia landscape

Schizophrenia is a chronic and debilitating mental illness that affects approximately 24 million people worldwide.

Treatment for schizophrenia primarily involves the use of antipsychotic drugs, which target the positive symptoms of the disorder.

These medications however are often ineffective for addressing the cognitive and negative symptoms, which have a significant impact on long-term functioning and disability. Currently, there are no approved medications specifically targeting cognitive impairment in schizophrenia.