- Main endpoint met in section 2a POC trial in postpartum melancholy with a MADRS discount from baseline of –35.4 factors (p<0.0001, n=10) and 100% of sufferers in remission at Day 8
- Main endpoint met in section 2a POC trial in bipolar II dysfunction with a present main depressive episode with a MADRS discount from baseline of –16.8 factors (p=0.0099, n=6) and 33% of sufferers in remission at Day 8
- In each trials, GH001 was properly tolerated and no treatment-related severe adversarial occasions have been reported
- Inhalation toxicology examine in a non-rodent species was accomplished with no histology findings within the respiratory tract of any canines within the examine at any dose degree
- Extra inhalation toxicology examine in rats was accomplished supporting our place that respiratory tract histology findings are rat particular
- Our response to FDA’s request for added gadget design verification data is being ready
- Full response to the IND maintain deliberate to be submitted in mid-2025
- Prime-line knowledge from our randomized, double-blind, placebo-controlled Part 2b trial in TRD on observe to be introduced in Q1 2025
DUBLIN, Jan. 10, 2025 (GLOBE NEWSWIRE) — GH Analysis PLC GHRS, a clinical-stage biopharmaceutical firm devoted to reworking the therapy of psychiatric and neurological issues, as we speak offered updates on its enterprise and highlighted key upcoming milestones.
Main Endpoint Met in Part 2a Proof-of-Idea Trial in PPD
The first endpoint of the Part 2a proof-of-concept (POC) trial for GH001 in postpartum melancholy (PPD) was met with a major discount from baseline of –35.4 factors (96.3%) in Montgomery–Åsberg Despair Score Scale (MADRS) whole rating on Day 8 after administration of GH001 (p<0.0001). On Day 8, 100% of sufferers have been in remission (MADRS ≤ 10).
GH001 led to an ultra-rapid antidepressant impact with a major discount in MADRS rating at 2 hours after administration of –31.4 factors (p<0.0001) and on Day 2 of –36.0 factors (p<0.0001).
The trial recruited 10 sufferers with PPD. All sufferers have been administered an individualized dosing routine (IDR) of as much as three escalating doses of GH001. There was no psychotherapeutic intervention on this trial. The imply whole MADRS rating on Day 8 was 1.3 and all 10 sufferers have been in remission.
GH001 was properly tolerated and no treatment-related severe adversarial occasions have been reported. All treatment-emergent adversarial occasions (TEAEs) have been delicate or average.
Main Endpoint Met in Part 2a Proof-of-Idea Trial in BDII
The first endpoint of the Part 2a POC trial for GH001 in bipolar II dysfunction with a present main depressive episode (BDII) was met with a major discount from baseline of –16.8 factors (51.9%) in MADRS whole rating on Day 8 after administration of GH001 (p=0.0099). On Day 8, 33.3% of sufferers have been in remission (MADRS ≤ 10).
GH001 led to an ultra-rapid antidepressant impact with a discount in MADRS rating at 2 hours after administration of –16.3 factors (p=0.0006) and on Day 2 of -13.3 factors (p=0.0299).
The trial recruited 6 sufferers with BDII. All sufferers have been administered an IDR of as much as three escalating doses of GH001. There was no psychotherapeutic intervention on this trial.
GH001 was properly tolerated and no treatment-related severe adversarial occasions have been reported. Nearly all of TEAEs have been delicate or average and there have been no reported TEAEs of hypomania or mania.
Replace on IND for GH001
As beforehand introduced, our Investigational New Drug Software (IND) for GH001 administered utilizing our proprietary aerosol supply gadget has been positioned on medical maintain by the U.S. Meals and Drug Administration (FDA), with the FDA requesting that we offer (i) an inhalation toxicology examine in a non-rodent species and a further inhalation toxicology examine in rats, (ii) extra gadget design verification data and (iii) updates to our investigator brochure, to resolve the maintain.
The requested extra inhalation toxicology examine in a non-rodent species has now been accomplished. The pathology report concludes that there are not any histology findings within the respiratory tract of any canines at any dose degree evaluated within the examine.
The requested extra inhalation toxicology examine in rats has now been accomplished which confirmed histology findings in step with our beforehand accomplished examine in rats. This helps our place that these findings are rat particular.
Primarily based on beforehand introduced FDA interactions, the response to their request for added gadget design verification data is being ready and, along with the completion of the inhalation toxicology research, offers the ultimate piece of knowledge requested by the company.
We’re making ready to interact with the FDA prematurely of offering a full response to the IND maintain which we plan to submit in mid-2025.
Enterprise Updates
GH001 in Sufferers with TRD
As beforehand introduced, we accomplished enrolment of the double-blind section of our randomized, double-blind, placebo-controlled Part 2b trial in 80 treatment-resistant melancholy (TRD) sufferers within the third quarter of 2024, with top-line knowledge on observe to be introduced within the first quarter of 2025. This trial additionally features a 6-month open-label extension which is on observe for completion of final affected person go to within the first quarter of 2025.
Money Place
Money, money equivalents, different monetary belongings and marketable securities have been $182.6 million as of December 31, 2024, in comparison with money, money equivalents, different monetary belongings and marketable securities of $222.7 million as of December 31, 2023.
About GH Analysis PLC
GH Analysis PLC is a clinical-stage biopharmaceutical firm devoted to reworking the therapy of psychiatric and neurological issues. GH Analysis PLC’s preliminary focus is on growing its novel and proprietary mebufotenin therapies for the therapy of sufferers with treatment-resistant melancholy (TRD).
About GH001
Our lead product candidate, GH001, is formulated for mebufotenin administration through a proprietary inhalation method. Primarily based on the noticed medical exercise in our accomplished section 1/2 GH001-TRD-102 trial, the place 87.5% of sufferers with TRD achieved ultra-rapid remission with our GH001 individualized single-day dosing routine within the Part 2 a part of the trial, we consider that GH001 has the potential to alter the way in which TRD is handled as we speak.
About Notation for Trial Timepoints
In relation to our medical trials we’ve got beforehand referred to the day of dosing as Day 0 (D0), the day after dosing as Day 1 (D1), and the seventh day after dosing as Day 7 (D7). On this press launch, and going ahead, we will seek advice from the day of dosing as Day 1 (D1), the day after dosing as Day 2 (D2) and the seventh day after dosing as Day 8 (D8).
Ahead-Trying Statements
This press launch incorporates statements which are, or could deemed to be, forward-looking statements. All statements apart from statements of historic truth included on this press launch, together with statements relating to our future outcomes of operations and monetary place, enterprise technique, product candidates, analysis pipeline, ongoing and at the moment deliberate preclinical research and medical trials, regulatory submissions and approvals, analysis and improvement prices, timing and probability of success, in addition to plans and aims of administration for future operations are forward-looking statements. Ahead-looking statements seem in various locations on this press launch and embody, however aren’t restricted to, statements relating to our intent, perception or present expectations. Ahead-looking statements are primarily based on our administration’s beliefs and assumptions and on data at the moment obtainable to our administration. Such statements are topic to dangers and uncertainties, and precise outcomes could differ materially from these expressed or implied within the forward-looking statements because of numerous components, together with, however not restricted to, these described in our filings with the U.S. Securities and Change Fee. No assurance may be provided that such future outcomes might be achieved. Such forward-looking statements contained on this doc communicate solely as of the date of this press launch. We expressly disclaim any obligation or enterprise to replace these forward-looking statements contained on this press launch to mirror any change in our expectations or any change in occasions, situations, or circumstances on which such statements are primarily based until required to take action by relevant regulation. No representations or warranties (expressed or implied) are made in regards to the accuracy of any such forward-looking statements.
Investor Relations
Julie Ryan
GH Analysis PLC
[email protected]
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