Terran Biosciences announces exclusive licensing deal with Pierre Fabre for idazoxan; Terran completes key development milestones

• Terran obtains exclusive global development and commercialization rights for idazoxan, a late-stage clinical therapeutic for schizophrenia
• Development of novel XR formulation and GMP manufacturing completed to phase 3 standards
• First cohort dosed in clinical trial of XR idazoxan, early data demonstrate successful once-daily PK release profile
• FDA meeting completed, provided guidance on development path forward

NEW YORK, June 2, 2023 /PRNewswire/ -- Terran Biosciences, Inc. ("Terran"), a CNS-focused biotech platform company, has entered into an agreement with French pharmaceutical company Pierre Fabre Médicament S.A.S ("Pierre Fabre") for worldwide exclusive rights to develop and commercialize a pipeline of Pierre Fabre's assets to treat neuropsychiatric illnesses.

The deal features the novel lead compound idazoxan, a selective alpha 2 receptor antagonist, along with a portfolio of other compounds with a similar mechanism of action. Idazoxan has been tested in multiple phase 3 clinical studies and has been dosed in over 1,000 patients across a variety of neuropsychiatric indications. Phase 2 proof-of-concept trials have demonstrated idazoxan's safety and efficacy as adjunctive therapy in patients with schizophrenia, showing a statistically significant improvement in symptoms nearly double that of standard antipsychotic therapy alone. However, despite the promising safety and efficacy profile, idazoxan had a short half-life that required dosing 3 times daily to achieve the desired plasma levels and pharmacological effects, which restricted its development.

Building on Pierre Fabre's Drug Master File, the Terran CMC team set out to solve the challenges around half-life and pharmacokinetics, and made a number of improvements to the process, resulting in innovative extended-release formulations ("idazoxan XR"), to enable once daily oral dosing with improved ease of use. In previous trials, idazoxan was dosed as a racemic compound (a mixture of half R-idazoxan and S-idazoxan); however, only one of the enantiomers is considered active at the target receptor. Terran has now manufactured enantiomerically pure idazoxan to phase 3 standards and has developed five new clinical drug product forms of idazoxan XR, including pure R-idazoxan, pure S-idazoxan, and racemic idazoxan with different release profiles.

The five new forms of idazoxan XR are currently being evaluated in an ongoing multisite phase 1 clinical trial in which Terran plans to enroll more than 100 healthy volunteers. The first cohort of subjects in this trial has been dosed, and early analysis of the results demonstrate the intended once-daily pharmacokinetic profile has successfully been achieved. Further study results will confirm which optimized form and dose to take forward into the planned phase 2 study in over 200 patients with schizophrenia.

Terran also recently completed a meeting with the FDA confirming that, pending analysis of the final study data, the design of the current study should enable the use of any of the selected XR formulations in the larger phase 2 study.

Dr. Sam Clark, Terran's founder and CEO remarked, "We are thrilled to partner with the team at Pierre Fabre and to push forward with the development of idazoxan and this pipeline of CNS compounds. Given the strength of the human data to date, we believe idazoxan XR has the potential to revolutionize the treatment of patients with schizophrenia and other neuropsychiatric disorders."

About Terran Biosciences, Inc.

Terran is a biotech platform company developing a portfolio of therapeutics and technologies for patients with neurological and psychiatric diseases. Backed by a number of life-science and tech investors, Terran has built a CNS-focused, tech-enabled drug development platform, and is rapidly advancing a number of late-stage assets, which include novel psychedelic-based therapeutics.

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SOURCE Terran Biosciences, Inc.