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Our initial focus is on developing our novel and proprietary mebufotenin (5-methoxy-N,N-dimethyltryptamine, 5-MeO-DMT) product candidates for the treatment of patients with difficult-to-treat depression. With these programs, we are aiming to achieve increased remission rates and faster onset of action than current therapies, with durable effects, a favorable tolerability profile, and a convenient administration paradigm.

Our existing clinical programs with our lead product candidate, GH001, are targeted for the indications of treatment-resistant depression (TRD), bipolar II disorder (BDII), and postpartum depression (PPD) with the hope of addressing significant unmet needs in the treatment of these conditions.

Treatment-Resistant Depression 

Major depressive disorder (MDD) is a serious mental health condition affecting more than 320 million people worldwide, where patients experience symptoms including feelings of sadness, loss of interest, and other negative emotions. It is a leading cause of disability and ill health worldwide and is a major contributor to the overall global burden of disease. 

TRD refers to patients with MDD who have not responded to at least two different first-line antidepressants. Approximately a third of patients who are diagnosed with MDD have TRD and it is estimated that there are over 9 million patients living with TRD in the United States and Europe.

Although there are several antidepressant treatment options on the market, depression in general, and TRD in particular, comes with very high unmet medical needs. Therefore, there is a high need for effective, fast-acting, and well-tolerated treatments.

Bipolar II Disorder 

Bipolar disorder (BD) is a disorder that causes changes in a person’s mood, energy, and ability to function. People with BD experience recurrent episodes of depressed or elevated mood (called mania or hypomania).

BD can disrupt a person’s day-to-day life and relationships and can significantly reduce a person’s quality of life. BDII is diagnosed when a person experiences at least one episode of hypomania and one episode of major depression. It is estimated that more than 10 million people in the United States and Europe are affected by BDII. Although patients with BDII experience a milder form of mania called hypomania, compared to other types of BD, the burden of disease is still significant, and BDII patients spend more time with depressive symptoms.

Due to the high disease burden of depressive symptoms in BDII, and the fact that many patients do not respond adequately to or do not tolerate current treatment options, there is a high need for effective, fast-acting, and well-tolerated treatments.

Postpartum Depression

While more than 50% of women experience some form of low mood after childbirth, more than 15% suffer from PPD, a debilitating disorder defined as a major depressive episode occurring during pregnancy or after giving birth. In addition to the symptoms commonly associated with major depression, PPD may also lead to a wide range of negative consequences for the affected mother, her infant(s) and her family, including disruptions to the mother-child relationship.

PPD is primarily treated by psychological therapies and/or antidepressants. However, some women may be reluctant to take antidepressants during pregnancy and breastfeeding, due to factors such as concerns about harming the infant, or the stigma of taking antidepressants. As such, the treatment of PPD is uniquely challenging, and there is a need for novel treatments for this condition.