Entrada Therapeutics Inc（TRDA）のニュースとイベントTRDAEntrada Therapeutics Inc

Entrada Therapeutics Reports Q3 Revenue of $905,000

Reports Q3 revenue $905,000, consensus $5.87M. "The October Cohort 1 data from ELEVATE-45-201 marked our third consecutive readout demonstrating encouraging safety and tolerability across our clinical programs," said Dipal Doshi, Chief Executive Officer of Entrada Therapeutics. "With these initial dose cohorts supporting the safety profile of our lead Duchenne programs, our attention now turns to the next set of readouts designed to further define the potential of our investigational medicines. We expect the ELEVATE-44-201 Cohort 1 open-label data to provide important insights into the underlying biology and the durability of the early functional improvements observed to date. The ELEVATE-44-201 Cohort 1 open-label data readout will also include additional functional measures, reflecting nearly a year of treatment. Cohort 2 data from ELEVATE-44-201 and ELEVATE-45-201 will then further characterize the relationship between dose, exon skipping, dystrophin production and functional outcomes at both higher doses and exposure levels."

Entrada Therapeutics Appoints Linea Aspesi as Chief People Officer

Entrada Therapeutics announced the appointment of Linea Aspesi as chief people officer. Prior to Entrada, Aspesi served as chief people officer at KalVista Pharmaceuticals.

Entrada Therapeutics Releases Topline Data for ENTR-601-45 Clinical Trial

Entrada Therapeutics announced topline data from Cohort 1 of the double-blind, placebo-controlled, multiple ascending dose, or MAD, portion of the Phase 1/2 ELEVATE-45-201 clinical study of ENTR-601-45 in ambulatory participants with a confirmed mutation in the DMD gene amenable to exon 45 skipping. Study participants in Cohort 1 received three doses of 5 mg/kg of ENTR-601-45 or placebo. Topline results met the primary objectives of favorable safety and tolerability. The secondary objectives also met company expectations and demonstrated a 0.10% mean increase in dystrophin and a 0.15% mean increase in exon skipping compared with baseline levels in treated participants. All study participants in Cohort 1 have now progressed to the open-label, Phase 2 portion of the study, where they will receive six doses of 5 mg/kg of ENTR-601-45. Dystrophin measured by western blot and normalized to MHC; Dystrophin values are actual observed values, including values less thanLLOQ; Two participants in the ENTR-601-45 group had baseline dystrophin levels less thanLLOQ and greater thanLOD; LLOQ for dystrophin was 0.25%; LOD for dystrophin was 0.1%; Biopsy performed at baseline; LLOQ: Lower limit of quantification; LOD: Limit of detection; MHC: Myosin heavy chain. Favorable safety and tolerability with ENTR-601-45 at the 5 mg/kg dose. Headache was the most common treatment-emergent adverse event, or TEAE. One participant experienced 2 serious TEAEs of vomiting and pyrexia which subsequently resolved. There were no study discontinuations due to any cause, and all participants enrolled in the open-label extension. No hypomagnesemia or renal safety concerns were noted. Renal markers, including eGFR and cystatin C, were within normal ranges in treated participants. Magnesium levels were also within the normal range. Plasma ENTR-601-45 exposures were consistent with those predicted by juvenile non-human primate, or NHP, data. Modeled plasma exposures provide confidence in a significant increase in dystrophin expression at higher doses in Cohort 2 and Cohort 3. A mean increase of 0.10% from baseline in dystrophin production was observed in study participants who received ENTR-601-45 versus a 0.02% mean decrease from baseline in study participants who received placebo. A mean increase of 0.15% from baseline in exon skipping was observed in study participants who received ENTR-601-45 versus a 0.04% mean decrease from baseline in study participants who received placebo. Based on the age of Cohort 1 participants and baseline levels of function, no observable functional benefit was expected or observed after three doses of ENTR-601-45. Functional impact will be assessed with higher doses and over longer dosing periods via future cohorts and the open-label studies.