GHRS - GH Research Reports Positive Phase 2 Study Results For TRD
Psychedelic biotech company GH Research PLC (Nasdaq: GHRS) reported financial results for the third quarter ended September 30, 2021, and gave updates on its business. R&D expenses were $2.6 million for the quarter ended September 30, 2021, compared to $55 thousand for the same quarter in 2020. The increase was primarily due to increased activities relating to the company’s technical developments and clinical trials and increases in employee expenses to support these activities. the company has no revenue to report at this time.
G&A expenses were $2.1 million for the quarter versus $5 thousand for the same quarter in 2020. GH Research said the increase was primarily due to higher professional and compliance fees associated with being a public company, as well as increased employee expenses. The company also reported a net loss of $1.8 million, or $0.035 loss per share versus $60 thousand, or $0.002 loss per share, for the same quarter in 2020. Cash was $280.7 million as of September 2021 versus $5.9 million as of December 31, 2020.
GH Research lead product is GH001, which is an inhalable 5-MeO-DMT. The company also reported the successful outcome of the Phase 2 part of its Phase 1/2 clinical trial of GH001 in treatment-resistant depression (TRD), where the primary endpoint was met with 7 of 8 patients (87.5%) in remission (Montgomery–Åsberg Depression Rating Scale (MADRS) ?10) at day 7 after dosing (p<0.0001). According to the FDA Guidance for Industry, a 7-day endpoint is an appropriate primary efficacy endpoint for rapid-acting antidepressants.
GH Research said it plans to request a pre-IND meeting with the FDA and a Scientific Advice meeting with the EMA in the first quarter of 2022 and, pending the outcome of these meetings, it plans to initiate a multi-center, randomized, controlled Phase 2b trial of GH001 in TRD. The company also stated that it has recently initiated the development in two undisclosed psychiatric disorders which are expected to be announced in the first quarter of 2022.
In addition, the company also reported positive preliminary safety results from a Phase 1 clinical pharmacology trial in healthy volunteers (GH001-HV-103). This trial enrolled 46 healthy volunteers with 30-day safety follow-up. The trial investigated three different single doses of GH001 in a double-blind, placebo-controlled design (6 mg (n=8), 12 mg (n=8), 18 mg (n=8), placebo (n=2 in each dose group)) and a proprietary GH001 individualized dosing regimen with intra-subject dose escalation within a single day in an open-label, non-randomized design in two groups with two different intervals between doses (1 hour (n=8), 2 hours (n=8)).