William Blair Reiterates Outperform Rating on Entrada Therapeutics (TRDA)

William Blair analyst Myles Minter reiterated an Outperform rating on Entrada Therapeutics (NASDAQ: TRDA).

The analyst comments "Before the market open on Monday, March 24, Entrada announced the MHRA had cleared the Phase I/II multiple-ascending dose (MAD) study of ENTR-601-45, an EEV-conjugated DMD gene exon 45 skipping oligonucleotide, to initiate in the U.K. for patients with Duchenne muscular dystrophy (DMD) amenable to exon 45 skipping. Entrada is expected to commence the study in the third quarter of 2025, with ENTR-601-45 being the second asset leveraging the same EEV conjugate to enter clinical studies. The proposed study consists of two parts: part A is a MAD portion in approximately 24 DMD patients evaluating 3 dose cohorts (5-15 mg/kg) Q6W; part B is a dose optimization portion that will further assess functional outcomes and patient-reported quality-of-life scales prior to eligible patients entering an open-label extension study. ENTR-601-45 will be conducted in the U.K. and potentially EU clinical sites (under regulatory review) before sharing results with the FDA to potentially enable registrational studies in the U.S., which is a similar strategy being employed for ENTR-601-44. Importantly for Entrada, beyond Sarepta’s (SRPT $74.67; Outperform) Amondys 45, which is already FDA approved, ENTR-601-45 entering the clinic puts the asset as first-in-class for the next-gen exon skippers with what we believe is a best-in-class preclinical dataset (see here for latest MDA 2025 presentation). We followed up with the company, which believes the 5-15 mg/kg proposed dose range will be within the therapeutically and clinically relevant range and continue to target “double-digit” percent of normal dystrophin production for patients. For reference, the absolute and placebo-normalized change from baseline in percentage dystrophin of normal from muscle biopsy with 48 weeks of Amondys 45 (30 mg/kg/wk) was 0.81% and 0.59%, respectively (see the FDA label here). We note that the allowed 5-15 mg/kg dose range in the ELEVATE-45-201 study is slightly lower than the range being explored in the ELEVATE-44-201 study (6-18 mg/kg, Q6W) expected to initiate in the second quarter of 2025. In our follow-up with Entrada, the team suggested each EEV-conjugated oligo has differing PK/PD depending on sequence selection and that the proposed dose range was supported by the aforementioned preclinical data and projected modeling that supports the 5 mg/kg starting dose. Regardless, the range is well above the 0.16-1.28 mg/kg range proposed to be assessed in the ELEVATE-44-102 trial of ENTR-601-44 within the U.S., of which management still believes that two of those doses will be clinically effective."

For an analyst ratings summary and ratings history on Entrada Therapeutics click here. For more ratings news on Entrada Therapeutics click here.

Shares of Entrada Therapeutics closed at $10.80 yesterday.

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