At the ObesityWeek 2024, AstraZeneca Plc AZN shared data abstracts highlighting early data from AZD5004/ECC5004.
In November 2023, AstraZeneca announced an exclusive license agreement with Eccogene for potential obesity treatment, ECC5004, an investigational oral once-daily glucagon-like peptide 1 receptor agonist.
Eccogene received an initial upfront payment of $185 million. In addition, Eccogene will also receive up to an additional $1.825 billion in future milestone payments.
The company shared data from a double-blind, randomized, placebo-controlled study of ECC5004 in healthy participants in single doses (SAD) and participants with type 2 diabetes (T2DM) on metformin only and in multiple doses (MAD). The primary objective was to evaluate safety and tolerability.
In the SAD, 19 randomized participants received eight doses ranging from 1mg to 300mg.There were no serious adverse events (AEs), and gastrointestinal (GI) AEs were most common in doses ≥ 50mg.
Pharmacokinetic (PK) profiles demonstrated a linear profile and geometric mean half-life of between 11.06h (CV 14.2%) to 24.48h (CV 9.3%) and Tmax of 7.6h (CV 36.68) to 16.7 h (CV 101).
The researchers note that this first-in-human study demonstrated that ECC5004 has a safety and tolerability profile consistent with that observed for other small molecule GLP-1RAs and a PK profile compatible with once-daily dosing.
Changes in glucose levels and body weight suggest ECC5004 achieved target engagement of the GLP-1R.
Data from an open-label, randomized, single-dose cross-over study in 14 healthy participants under fasted/fed conditions showed that AZD5004/ECC5004 may be administered orally in the fasted or fed state as overall exposure and T1/2 are unaffected by food, suggesting that AZD5004/ECC5004 has the potential to be a more convenient, oral, once-daily therapy for patients.
The researchers added that prolonged Tmax, and lower Cmax observed in the fed state have the potential to confer better tolerability, but this will need to be evaluated in larger and longer studies, which are currently in progress.
Price Action: AZN stock is up 0.04% at $71.45 at the last check on Monday.
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