ARTHEx hires a rare disease CMO as its DM1 drug moves through Phase I/IIa

ARTHEx is Christian Freitag's third chief medical officer job. On 4 November, Valencia-based ARTHEx Biotech named him as its new CMO, as its lead RNA drug for myotonic dystrophy type 1 moves through an early clinical trial.

Who he is

Freitag, a physician who earned his medical degree at Kiel University, has more than two decades in pharma and biotech across clinical development, medical strategy and rare diseases. He joins from Azafaros, where he was CMO, and before that held the same role at Dynacure.

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Earlier in his career he led clinical R&D at Debiopharm International, covering programmes from Phase 1 to Phase 3. He held senior roles at BTG plc, including in global clinical development, and was vice president of global clinical development and innovation at Shire. He started at Hoffmann-La Roche in pharmacovigilance and medical affairs.

"Chris is an accomplished physician and clinical development leader" Frédéric Legros, Ph.D., chief executive officer, ARTHEx Biotech

What he's walking into

ARTHEx is a clinical-stage company developing RNA-based drugs for neuromuscular disorders. Its BOOST-ON platform pairs selective oligonucleotides with better delivery to skeletal muscle, heart and brain, the tissues that are hardest to reach in diseases like DM1.

The lead programme, ATX-01, is in the Phase I/IIa ArthemiR trial in DM1 and has FDA Fast Track Designation. The company is also evaluating it in myotonic dystrophy type 2, and plans more BOOST-ON programmes in muscle, CNS and cardiac diseases. The release doesn't give dates for data or next-stage trials.

Why the timing fits

A Fast Track programme in an early trial is at the point where the next decisions get expensive: dose selection, endpoints for a registrational study, and how to run it across sites in Europe and the US. A CMO who has taken rare disease programmes from early to late stage at several companies is the kind of hire that usually comes just before those calls.

Freitag said he was excited to join ARTHEx at such an important stage in the company's development.

The pattern

Delivery to muscle, heart and brain is the hard part of RNA medicine for neuromuscular disease, and it's what BOOST-ON is built around. Our read is that ARTHEx has chosen experience in late-stage rare disease development over a specialist in a single modality.

What it means for hiring

New CMOs at Phase I/IIa rare disease companies often build out clinical operations, biostatistics and medical affairs within their first year. We'd expect follow-on hiring under this role as the company plans its next stage of development.
Fast Track status means more frequent FDA interaction. In our view, European rare disease biotechs at this stage need regulatory affairs leaders who know US processes as well as EMA ones.
Neuromuscular and DM1 clinical experience is scarce. Candidates who have run trials in muscle diseases are well placed as more oligonucleotide programmes reach the clinic.

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