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Cingulate complete enrollment for study of treatment of anxiety disorders

Cingulate Inc., a clinical-stage biopharmaceutical company utilising its Precision Timed Release (PTR) drug delivery platform technology to build and advance a pipeline of pharmaceutical products, announced it has completed enrollment in its study to determine the appropriate formulation of its third asset, CTx-2103, for the management of anxiety-related disorders. This study was initiated in May 2022 with 12 enrollees. Results of the study are expected in July 2022.

Key highlights:

CTx-2103 contains the active pharmaceutical ingredient buspirone hydrochloride, a non-benzodiazepine medication, which has no evidence for the development or risk of dependency. However, due to its short half-life, buspirone is prescribed to be taken several times a day for management of anxiety, which can be challenging for patients and may lead to sub-optimal treatment outcomes. CTx-2103 will be designed as a once-daily, multi-dose tablet, which the company believes will offer clear differentiation and compelling advantages over currently available treatment options.

“We feel Cingulate’s Precision Timed Release drug delivery platform will allow us to design a single administration buspirone product that provides clinicians the ability to optimise treatment over the full course of the day,” said Shane J. Schaffer, chairman and chief executive officer, Cingulate.

“CTx-2103 represents the initial expansion of our clinical-stage pipeline into new therapeutic areas, which also includes two candidates for attention deficit/hyperactivity disorder (ADHD). This illustrates how our PTR platform technology can be applied to other therapeutic areas where current standard-of-care treatments require dosing several times a day, and in which a consistent, single-dose formulation may offer significant improvements for patients.”

Anxiety disorders are the most common mental health concern in the U.S. An estimated 31 percent of U.S. adults experience an anxiety disorder at some time in their lives. People may live with anxiety for years before they are diagnosed or treated.

“Our PTR technology has uniquely positioned us to create next-generation products that change the paradigm of oral drug delivery by combining multiple doses of drug into a single tablet,” said Matthew Brams, M.D., chief medical officer, Cingulate. “Nonadherence, which is a common issue with current anxiety medications, leads to suboptimal treatment outcomes for all stakeholders. CTx-2103 has the potential to be beneficial for patients, payors, and providers, and can be applied to markets beyond ADHD and anxiety, where once-daily dosing could make an important contribution to optimising treatment.”

Cingulate’s PTR platform incorporates a proprietary Erosion Barrier Layer (EBL) that provides control of drug release at precise, pre-defined times with no release of drug prior to the intended release. The EBL technology is enrobed around a drug-containing core to give a tablet-in-tablet dose form. It is designed to erode at a controlled rate until eventually the drug is released from the core tablet. The EBL formulation OralogiK is licensed from BDD Pharma.

“We are delighted to be partnering again with the Cingulate team to extend their pipeline of triple pulse products using BDD’s modified-release technology, OralogiK,” said Carol Thomson, chief executive officer, BDD Pharma. “CTx-2103 offers once-daily dosing and will be an exciting addition to the CNS market. This clinical formulation study utilises our SWIFT adaptive clinical trial platform to deliver rapid results and is the first significant step towards an accelerated route to market.”

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