On 17 June, Amylyx acquired the rights to Eiger Biopharmaceutical’s experimental glucagon-like peptide-1 (GLP-1) receptor antagonist, avexitide, for $35.1m. Avexitide was previously developed for post-bariatric hypoglycemia (PBH) and congenital hyperinsulinism (HI). Amylyx will now own all development, manufacturing, and commercialisation rights for avexitide. Unlike key, highly publicised therapies that address hyperglycemia, diabetes, and obesity, such as Novo Nordisk’s Ozempic (semaglutide) and Eli Lilly’s Mounjaro (tirzepatide), avexitide is intended to treat patients with low blood sugar. The acquisition is a notable action by Amylyx following the failure of its lead amyotrophic lateral sclerosis (ALS) therapy, Relyvrio (sodium phenylbutyrate and taurursodiol), formerly known as AMX0035.

ALS is a rapidly progressive, fatal neurodegenerative condition characterised by muscle weakness, atrophy, and spasticity arising from the gradual degeneration of both upper and lower motor neurons. The high failure rate observed in ALS clinical trials is often attributed to the disease’s unclear aetiology and complex pathophysiology. Amylyx’s Relyvrio, a neuroprotective agent, received conditional approval in September 2022 for the treatment of ALS in the US and Canada based on data from a Phase II study, CENTAUR (NCT03127514).

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As a condition of Relyvrio’s approval, Amylyx conducted a Phase III PHOENIX (NCT05021536) trial in ALS. On 8 March, Amylyx Pharmaceuticals announced that Relyvrio failed to meet the study’s primary endpoint of improved function in ALS patients (Amylyx Pharmaceuticals, press release, 8 March 2024). Following this monumental setback, the company announced the discontinuation of Relyvrio and the planned reduction of the company’s workforce by approximately 70%. Additionally, shares of Amylyx Pharmaceutical have since plummeted (Amylyx Pharmaceuticals, press release, 4 April 2024). Amylyx’s acquisition of avexitide is a clear signal from the company of its new commitment to re-enter the metabolic space following the failure of Relyvrio.

Prior to acquiring avexitide, Amylyx was not completely unfamiliar with the metabolic space, as AMX0035 was also being investigated for Wolfram syndrome. Wolfram syndrome is an inherited condition that generally includes childhood-onset, insulin-dependent diabetes mellitus. The majority of patients with Wolfram syndrome progressively develop diabetes insipidus, sensorineural hearing loss, and autonomic nervous system degeneration (Rigoli et al., 2022).

On 10 April, Amylyx released interim results from its ongoing HELIOS (NCT05676034) trial, which is a 12-participant, open-label, Phase II study investigating the safety and tolerability of AMX0035 for endocrinological function. Preliminary data indicated that AMX0035 administration enhanced total C-peptide response, a validated objective laboratory measure of pancreatic beta cell function and glycemic regulation. Moreover, AMX0035 demonstrated favourable outcomes across multiple key parameters in the HELIOS trial, including a mean reduction of 0.26% in haemoglobin A1C levels following 24 weeks of treatment. Continuous glucose monitoring revealed an average improvement of 7.1% in the absolute time spent within the target glycemic range. Additionally, all patients achieved either stabilisation or improvement of their condition by week 24 of treatment (Amylyx Pharmaceuticals, press release, 11 April 2024).

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