Breakthrough Clinical Results
GH Research PLC provided updates on its clinical-stage biopharmaceutical programs. The company announced a response from the FDA regarding its Investigational New Drug Application (IND) for GH001, with only one hold remaining related to respiratory tract histology findings in rats. Final data from the Phase 2b trial of GH001 in treatment-resistant depression (TRD) showed a 73% remission rate at 6 months. GH001 was well-tolerated with no treatment-related serious adverse events. The company also announced the completion of a Phase 1 trial for GH002, and plans to submit an IND in Q4 2025. A global pivotal program for GH001 is expected to initiate in 2026.
Key Highlights
- FDA response to GH001 IND received with one hold remaining.
- Final Phase 2b data for GH001 shows 73% remission rate at 6 months in TRD.
- Phase 1 trial of GH002 completed successfully.
- Global pivotal program for GH001 planned for initiation in 2026.
Incidence and Prevalence
Latest Estimates of Incidence and Prevalence of Treatment-Resistant Depression
Treatment-resistant depression (TRD) represents one of the most challenging outcomes of depression, characterized by functional impairment, suicidal thoughts, and decline in physical health. According to current research, TRD is defined as a lack of response to at least two adequate antidepressant treatments.
Prevalence Estimates
Recent epidemiological data indicates that treatment-resistant depression affects approximately 12%-20% of all depressed patients according to a 2015 literature review. More specifically, a 2014 primary care study found the overall prevalence of TRD was 21.7%, with no significant differences observed between genders or among different ethnicities.
Clinical Characteristics
Patients with TRD typically experience: - 3.8±2.1 prior depressive episodes - Illness duration of 4.4±3.3 years - 4.7±2.7 unsuccessful drug trials involving 2.1±.3 drug classes - Response rates of only 36%±1% - 17%±6% had prior suicide attempts (1.1±.2 attempts per patient)
Risk Factors
The most frequently reported risk factors for developing TRD include:
Mental factors: - Greater symptom severity (9 studies) - Suicidality (8 studies) - Recurrent depression (6 studies)
Physical factors: - Cardiovascular disease (4 studies) - Pain (3 studies) - Thyroid dysfunction (3 studies) - Obesity and being overweight
Demographic factors: - Younger age (7 studies) - Female gender (6 studies)
Psychological factors: - Higher levels of neuroticism
Recent genetic research involving 1,148 patients with major depressive disorder found associations between TRD and gene sets involved in cyclic adenosine monophosphate mediated signal and chromatin silencing.
Economic Impact
The economic burden of TRD is substantial: - Annual costs for health care and lost productivity were $5,481 and $4,048 higher, respectively, for TRD patients versus treatment-responsive depression - TRD may present an annual added societal cost of $29-$48 billion - This pushes the total societal costs of major depression to as much as $106-$118 billion - In Malaysia, the average healthcare cost per TRD patient (RM1,845) was 55% higher than that of MDD patients (RM839)
TRD patients exhibit significantly higher health-care utilization, including a fivefold increase in the likelihood of attending more than 10 consultations.
Given its complex nature and significant burden, early identification of contributing factors and appropriate intervention are crucial to prevent TRD development or improve treatment outcomes.
Economic Burden
Economic Burden of Treatment-Resistant Depression in USA and Europe
United States Economic Burden
The economic burden of Treatment-resistant depression (TRD) is substantial in both direct medical costs and productivity losses. According to 2020 studies using Medicare data, TRD patients had significantly higher total per-patient-per-year (PPPY) healthcare costs than non-TRD MDD patients ($25,517 vs. $20,425, adjusted cost difference = $3,385) and non-MDD patients ($25,517 vs. $14,542, adjusted cost difference = $4,015, all P<0.001).
A comprehensive 2020 study across multiple payer types (Medicaid, Medicare, and commercial) found that patients with TRD incurred $4,093 to $8,054 higher annual costs compared to those with treatment-responsive depression. These patients also experienced higher healthcare resource utilization (HRU) with higher hospitalization rates (odds ratios=1.32-1.76), more emergency department visits (odds ratios=1.38-1.45), and more outpatient visits (incident rate ratio=1.29-1.54).
A 2021 study using the Optum Clinformatics™ claims database compared commercially insured TRD patients to non-TRD MDD patients and found that TRD patients had: - More emergency department visits (odds ratio=1.39) - More inpatient hospitalizations (odds ratio=1.73) - Longer hospital stays (mean difference=2.86 days) - Higher total healthcare costs (mean difference=US$3,846)
Earlier studies showed that total depression-related and general medical health care expenditures increased significantly as treatment-resistant depression increased in severity. Patients in the hospitalized treatment-resistant group had over 6 times the mean total medical costs of non-treatment-resistant depressed patients ($42,344 vs. $6512) (p<.001), with total depression-related costs being 19 times greater ($28,001 vs. $1455) (p<.001).
European Economic Burden
In the United Kingdom, a 2015 study found that the mean cost of Cognitive Behavioral Therapy (CBT) per TRD participant was £910, with an incremental cost-effectiveness ratio of £14,911 (representing a 74% probability of being cost-effective at the NICE threshold of £20,000 per QALY). The difference in QALY gain between CBT plus usual care versus usual care alone was 0.057, equivalent to 21 days a year of good health.
A 2015 Japanese study reported that medical costs per patient during treatment intervals were 1.01 million JPY (0.540 million JPY per patient-year) in the TRD population compared to 0.643 million JPY (0.645 million JPY per patient-year) in the pharmaceutically-treated depression population who did not convert into TRD.
General Impact
Between 29% and 46% of depressed patients fail to respond adequately to antidepressant medication, contributing to the substantial economic burden of depression treatment. TRD patients are at least twice as likely to be hospitalized (general medical and depression related) and have at least 12% more outpatient visits (p<.02). They also use 1.4 to 3 times more psychotropic medications (including antidepressants) than non-treatment-resistant patients (p<.001).
Drug used in other indications
GH001 Clinical Trials Beyond Treatment-Resistant Depression
I cannot provide information about clinical trials of GH001 for indications other than treatment-resistant depression, as there is no data available about this compound in the provided materials. Without specific information about GH001 clinical trials, intervention models, dosing regimens, or administration methods, I'm unable to detail which other indications this compound might be investigated for.
If you're interested in learning about GH001 clinical trials for conditions beyond treatment-resistant depression, I would recommend consulting:
- Clinical trial registries such as ClinicalTrials.gov
- Scientific literature databases like PubMed
- The manufacturer's website or published research
- Regulatory agency documents from FDA or EMA
These sources would provide accurate and up-to-date information about any ongoing or completed clinical trials involving GH001 for various indications.