Cingulate raises $3m for daily anxiety treatment development

Cingulate, a US-based biopharmaceutical firm, has secured a $3 million grant from a private foundation to accelerate the development of a novel anxiety treatment. This project focuses on CTx-2103, a once-daily buspirone tablet that leverages Cingulate's precision timed release (PTR) drug delivery system. This financial support is structured to be disbursed in three separate installments of $1 million each. The initial payment is slated for May 1, 2025, with subsequent payments dependent on meeting specific developmental milestones for CTx-2103.

In exchange for this financial backing, the foundation is set to receive royalties from the future sales of CTx-2103. These royalties will commence six months after the first commercial sale of the drug and are valued at $500,000 per quarter, with an overall cap of $3.5 million in cumulative royalties. The formulation is currently being evaluated for its effectiveness in treating anxiety and similar disorders.

The core ingredient of CTx-2103, buspirone, is an azapirone derivative that acts as a partial agonist at the 5-hydroxytryptamine receptor 1A (5-HT1A). Buspirone made its debut as the initial non-benzodiazepine anxiolytic designed for individuals suffering from generalized anxiety disorder. It is particularly noted for its potentially reduced side-effect profile, especially the decreased risks of physical dependence or withdrawal symptoms typically associated with other anxiolytic medications.

According to Shane Schaffer, CEO and chairman of Cingulate, the funding marks a significant milestone in the company's efforts to develop a once-daily medication for anxiety—a condition that affects millions globally and represents the most prevalent mental health issue both in the United States and worldwide. Schaffer expressed gratitude for the foundation's support, emphasizing that the grant furthers Cingulate’s research pipeline and showcases the potential of their PTR platform.

The company's PTR technology is a crucial component of this development. It features an erosion barrier layer (EBL) that meticulously controls the timing of drug release, ensuring the medication is delivered at predetermined intervals. This technology is not only being applied to anxiety treatments but is also being explored for other conditions such as attention deficit hyperactivity disorder (ADHD).

In a related development in 2023, Cingulate entered into a joint commercialisation agreement with Indegene, a company specializing in life sciences commercialisation. This collaboration centers on the development of CTx-1301 (dexmethylphenidate), another therapeutic product aimed at treating ADHD. This partnership underscores Cingulate’s commitment to leveraging its PTR platform across multiple therapeutic areas, potentially expanding the horizon of treatment options for anxiety and ADHD patients.

Overall, Cingulate's innovative approaches in drug formulation and delivery technology hold promise for advancing the treatment landscape for anxiety and other related disorders, with the ultimate aim of improving patient outcomes and quality of life.