Terran Biosciences Seals Deal With France's Pierre Fabre Pharmaceutical

New York-based biotech Terran Biosciences has signed an agreement with French pharmaceutical company Pierre Fabre Médicament for worldwide exclusive rights to develop and commercialize a list of the latter's assets targeting neuropsychiatric conditions.

The licensing deal includes the novel late-stage clinical compound idazoxan, a selective alpha 2 receptor antagonist for schizophrenia treatment, as well as several other compounds with a similar mechanism of action. 

Idazoxan has been tested in multiple Phase 3 clinical studies and delivered to 1,000 patients with a variety of neuropsychiatric indications, with prior Phase 2 trials demonstrating safety and a significant improvement in symptoms when administered together with antipsychotic therapy in patients with schizophrenia. 

In those trials, idazoxan showed a short half-life, requiring 3 daily doses to achieve the desired plasma levels and effects. In response, Terran made a number of changes to the original drug development process, which resulted in new extended-release formulations -altogether “idazoxan XR”- to enable daily oral dosing with improved ease of use. 

Terran’s founder and CEO Dr. Sam Clark says the strong clinical results indicate that idazoxan XR has “the potential to revolutionize the treatment of patients with schizophrenia and other neuropsychiatric disorders."

In previous trials, idazoxan was dosed as a racemic compound: half R-idazoxan and half S-idazoxan. As only one of the enantiomers is considered active at the target receptor, Terran manufactured clinical-grade enantiomerically pure idazoxan as well as five new drug product forms of idazoxan XR -including pure R-idazoxan and S-idazoxan, and racemic idazoxan with different release profiles.

The five new forms are currently undergoing a multisite Phase 1 trial. With an expected total enrollment of 100 healthy volunteers, the first study cohort has already been dosed and early analysis showed positive outcomes. 

Further study results will confirm the optimal form and dose to continue studying in a planned Phase 2 study involving over 200 patients with schizophrenia which has received a preliminary go-ahead from the FDA.

Breakthrough In the Chemistry Of MDMA, Enantiomers & Analogs, New Salts & Polymorphs And PCT Application

On May 26, Terran announced the publication of an international patent application covering what could be the first comprehensive salt and polymorph screens of a list of empathogens including MDMA, (R)-MDMA, (S)-MDMA, MDEA (MDE), (S)-MDEA, (R)-MDEA, MDAI, MBDB, (S)-MBDB, (R)-MBDB and MEAI.

This is not the first time Terran hits the news with what could be historical discoveries related to “classical psychedelics,” as shown in a recent revision of psilocybin’s chemistry.

In the case of MDMA, the drug has only been developed as a single salt and the crystal structures of its enantiomers had not been characterized, in view of which Terran's researchers performed a comprehensive salt and polymorph screen that resulted in novel MDMA forms.

As an alternative to MDMA, the company is also developing its shorter-acting analog MDEA, with reported similar potency and empathogenic effects with fewer undesirable side effects, as well as MBDB, MDAI and MEAI, all three described as “very mild empathogens” potentially more suitable for at-home use in an outpatient basis. 

See also: Terran Biosciences' Four Patent Applications Cover Improved Versions Of Classic Empathogens

Dr. Clark says the discovery of the new forms of the empathogens MDMA, MDEA, MBDB, and other analogs “really changes the opportunity set for these molecules, enabling development programs for these new chemical entities” and that the advances “make available a broad set of therapeutic candidates with diverse use profiles customized for individual patient needs."

Terran says the newly-published PCT application contains work spanning multiple years and “is one of the most comprehensive novel empathogen development programs in the industry.”

Photo: Benzinga edit with photo by aiyoshi597, Gisele Yashar, Bacsica and Gorodenkoff on Shutterstock.