On track to dose first participant in ENTR-601-44 Phase 1 clinical trial in the United Kingdom in September 2023 –
– $377 million in cash, cash equivalents and marketable securities as of June 30, 2023 –
– Cash runway through 2025 –
Entrada Therapeutics, Inc. TRDA, a biopharmaceutical company aiming to transform the lives of patients by establishing intracellular Endosomal Escape Vehicle (EEV™)-therapeutics as a new class of medicines, today reported financial results for the second quarter ending June 30, 2023, and highlighted recent business updates.
"We are excited to transition into a clinical stage company with the initiation of our planned Phase 1 trial for our lead Duchenne product candidate, ENTR-601-44. There is a profound need for people living with Duchenne who are exon 44 skipping amenable and we look forward to dosing the first participant in the United Kingdom this September," said Dipal Doshi, President and Chief Executive Officer of Entrada Therapeutics. "Our fundamentals are strong and with the extension of our cash runway through the end of 2025, we believe we are well-positioned to advance our Duchenne franchise and introduce new indications outside of neuromuscular diseases, creating value for patients and shareholders alike."
Recent Corporate Highlights
Entrada received authorization from the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) and Research Ethics Committee (REC) for its Clinical Trial of an Investigational Medicinal Product (CTIMP) for a Phase 1 clinical trial in healthy volunteers for ENTR-601-44, the Company's lead product candidate within its Duchenne franchise. This trial is an important part of the overall global clinical development of ENTR-601-44 and the Company believes it will provide clinical data to support the program's next steps, which include a global multiple ascending dose trial in patients with Duchenne who are exon 44 skipping amenable.
The Phase 1 clinical trial's primary objective is to evaluate the safety of a single dose of ENTR-601-44 in healthy volunteers, with a target enrollment of approximately 40 participants. It will also evaluate tolerability, pharmacokinetics and target engagement as measured by exon skipping in the skeletal muscle. The first participant is expected to be dosed in September of this year with data anticipated in the second half of 2024.
In parallel, Entrada is committed to resolving the clinical hold on its Investigational New Drug (IND) application for ENTR-601-44 with the U.S. Food and Drug Administration (FDA) and expects to provide an update in the fourth quarter of 2023.
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