Foghorn Therapeutics Announces Clinical Data from Phase 1 Study of FHD-286 in Metastatic Uveal Melanoma

- Clinical data support safety and tolerability profile of FHD-286, a highly potent,

- selective, allosteric, oral, small molecule inhibitor of BRG1/BRM

- Clinical activity observed in late-line metastatic uveal melanoma includes nine patients with stable disease and one patient with a confirmed partial response

- Foghorn does not plan to advance FHD-286 in uveal melanoma

- Foghorn anticipates initiating a FHD-286 combination study in relapsed/refractory AML during the third quarter of 2023

CAMBRIDGE, Mass., June 28, 2023 (GLOBE NEWSWIRE) -- Foghorn Therapeutics Inc. (Nasdaq: FHTX), a clinical-stage biotechnology company pioneering a new class of medicines that treat serious disease by correcting abnormal gene expression, today announced data from the Phase 1 dose escalation safety study of FHD-286 in metastatic uveal melanoma (mUM). These data reinforce the safety and tolerability profile of FHD-286. At this time, the company does not plan to advance FHD-286 in uveal melanoma.

“The clinical data further support the safety and tolerability of FHD-286 and build on the previously disclosed AML/MDS data. In the study, nine patients had stable disease and one patient had a durable partial response,” said Adrian Gottschalk, President and Chief Executive Officer of Foghorn. “However, Foghorn does not plan to pursue this indication on its own. We plan to initiate dosing the FHD-286 combination study in relapsed/refractory AML during the third quarter of 2023 and continue to invest in our promising pre-clinical programs such as Selective-BRM, CBP, EP300, and ARID1B.”

FHD-286 Phase 1 Dose Escalation Study Data in Metastatic Uveal Melanoma

The trial evaluated 73 metastatic uveal melanoma patients who had been treated with a median of two prior therapies across nine different cohorts. The doses evaluated included four continuous daily doses: 2.5mg (n=2), 5.0mg (n=12), 7.5mg (n=17), and 10.0mg (n=9); and five intermittent 1 week on/1 week off dose cohorts: 10.0mg (n=10), 15.0mg (n=9), 17.5mg (n=3), 20.0mg (n=5), and 22.5mg (n=6).

Clinical data seen in the Phase 1 dose escalation study reinforced the safety and tolerability profile of FHD-286. The most common treatment-related adverse events were dysgeusia, fatigue, AST increase, nausea/vomiting, dry mouth, and rash. The most common treatment-related grade 3 events or higher included anemia, asthenia, ALP increase, hypokalemia, muscular weakness, and rash.