BHV-7000 for Depression

Recruiting at 67 trial locations

Overseen By Chief Medical Officer

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Biohaven Therapeutics Ltd.

Disqualifiers: Medical condition, Non-compliance, Risk to others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

480 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new medication called BHV-7000 to see if it is safe and well-tolerated over several months in people with Major Depressive Disorder. The goal is to help those who suffer from severe depression by potentially offering a new treatment option.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the study team for guidance.

Is BHV-7000 safe for humans?

The safety data for AVN-101, a similar 5-HT7 receptor antagonist, shows it is well tolerated in humans at doses up to 20 mg daily, with low toxicity and no significant side effects in early clinical trials. ^{1 2 3 4 5}

Eligibility Criteria

This trial is for individuals who have completed the initial phase of parent studies on Major Depressive Disorder (MDD). Women of childbearing potential must not be pregnant, breastfeeding, or lactating and should test negative for pregnancy to participate.

Inclusion Criteria

I have finished the initial phase of a previous study.

I am a woman of childbearing potential and my pregnancy test before starting the trial is negative.

I am not breastfeeding or planning to during the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BHV-7000 to evaluate long-term safety and tolerability

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• BHV-7000

Trial Overview The study is focused on assessing the long-term safety and tolerability of a medication called BHV-7000 in people with MDD. It aims to understand how well patients can handle this treatment over an extended period.

Participant Groups

Group I: BHV-7000 Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Biohaven Therapeutics Ltd.

Lead Sponsor

Trials

13

Recruited

4,800+

Findings from Research

AVN-101 is a multi-targeted drug candidate that acts primarily as a potent 5-HT7 receptor antagonist, showing good oral bioavailability and the ability to cross the blood-brain barrier, making it a promising treatment for CNS disorders.

In Phase I clinical trials, AVN-101 was well tolerated at doses up to 20 mg daily, with low toxicity and no significant effects on plasma biochemistry or heart rhythm, indicating a favorable safety profile for further testing in conditions like Alzheimer's disease and anxiety disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

AVN-101: A Multi-Target Drug Candidate for the Treatment of CNS Disorders. Ivachtchenko, AV., Lavrovsky, Y., Okun, I.[2019]

The compound N-2'-chlorobiphenylylmethyl 2-methoxyphenylpiperazinylpentanamide (1-8) was identified as a highly selective antagonist of the 5-HT7 receptor, showing a strong binding affinity and potential for treating depression and neuropathic pain.

In animal tests, this novel antagonist demonstrated antidepressant effects at a dose of 25 mg/kg, exhibiting a U-shaped dose-response curve typical of effective 5-HT7R antagonists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel N-biphenyl-2-ylmethyl 2-methoxyphenylpiperazinylalkanamides as 5-HT7R antagonists for the treatment of depression. Kim, Y., Tae, J., Lee, K., et al.[2014]

The selective 5-HT7 receptor antagonist SB 269970 demonstrated specific antianxiety effects in multiple behavioral tests in rats and mice, indicating its potential as an anxiolytic treatment.

SB 269970 also showed antidepressant-like activity in mice without affecting their locomotor activity, suggesting it may be a safer option with fewer side effects compared to standard drugs like diazepam and imipramine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of the selective 5-HT7 receptor antagonist SB 269970 in animal models of anxiety and depression. Wesołowska, A., Nikiforuk, A., Stachowicz, K., et al.[2019]

HBK-15, a novel 5-HT1A and 5-HT7 receptor antagonist, demonstrated antidepressant and anxiolytic effects in a mouse model of chronic stress, showing potential to alleviate depressive and anxiety-like behaviors while enhancing memory.

The pharmacokinetic profile of HBK-15 revealed rapid absorption and significant brain penetration, suggesting its effectiveness in targeting the central nervous system, which may be beneficial for treating depression with cognitive dysfunction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HBK-15 protects mice from stress-induced behavioral disturbances and changes in corticosterone, BDNF, and NGF levels. Pytka, K., Głuch-Lutwin, M., Kotańska, M., et al.[2018]

Chemical modifications of compound 1 (DR4004) led to the development of new compounds (7-10) that maintained high affinity and selectivity for the 5-HT(7) receptor while improving metabolic stability.

Compound 10 (DR4485) demonstrated oral bioavailability, making it a promising candidate for further research into the therapeutic potential of 5-HT(7) antagonists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New tetrahydrobenzindoles as potent and selective 5-HT(7) antagonists with increased In vitro metabolic stability. Kikuchi, C., Suzuki, H., Hiranuma, T., et al.[2019]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

AVN-101: A Multi-Target Drug Candidate for the Treatment of CNS Disorders. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Novel N-biphenyl-2-ylmethyl 2-methoxyphenylpiperazinylalkanamides as 5-HT7R antagonists for the treatment of depression. [2014]

3. England pubmed.ncbi.nlm.nih.gov

Effect of the selective 5-HT7 receptor antagonist SB 269970 in animal models of anxiety and depression. [2019]

4. Netherlands pubmed.ncbi.nlm.nih.gov

HBK-15 protects mice from stress-induced behavioral disturbances and changes in corticosterone, BDNF, and NGF levels. [2018]

5. England pubmed.ncbi.nlm.nih.gov

New tetrahydrobenzindoles as potent and selective 5-HT(7) antagonists with increased In vitro metabolic stability. [2019]