AGLE - Aeglea slumps ~25% as trial results trigger strategic options workforce reduction

2023-04-12 08:03:23 ET

Aeglea BioTherapeutics ( NASDAQ: AGLE ) said it is exploring strategic alternatives and reducing its workforce, including departure of chief business and medical officers, following interim results from an ongoing phase 1/2 trial of pegtarviliase to treat Classical Homocystinuria (CH).

CH is a rare inherited disorder in which the body is unable to fully break down an amino acid methionine which results in elevated levels of a chemical called homocysteine.

Phase 1/2 trial :

In the ongoing study, people received pegtarviliase — a novel recombinant human enzyme — once a week for four weeks to check safety and efficacy; 11 participants completed dosing and were considered evaluable. One person withdrew from the study due to personal reasons.

The company said data from the first two groups (0.15 mg/kg and 0.45 mg/kg, respectively) showed that pegtarviliase lowered total homocysteine levels, compared to baseline values.

However, data from the third group (1.35 mg/kg) did not show a consistent reduction in total homocysteine levels compared to baseline.

The company noted that further analysis suggested that people in the third group developed anti-drug antibodies (ADAs), which may have impacted the pharmacokinetics and reduced the effect of pegtarviliase in reducing total homocysteine levels.

The data suggests that exploring higher doses or dosing of longer duration may be required to determine the potential efficacy of pegtarviliase in lowering total homocysteine, the company added.

"We have produced valuable information in our clinical program for pegtarviliase that we believe ultimately benefits the Homocystinuria community but, unfortunately, we do not believe the data we currently have support immediate dialogue with regulators on a pivotal trial design," said Aeglea President and CEO Jeffrey Goldberg.

Pegtarviliase was well tolerated with the majority of adverse events being grade 1 or grade 2 injection site reactions and hypersensitivity reactions. There was one serious adverse event which was assessed as unrelated to therapy, according to the company.

Strategic Alternatives :

Aeglea said it has engaged Wedbush Securities as the exclusive financial advisor to help explore strategic alternatives.

These may include, acquisition, merger, reverse merger, other business combination, sales of assets or other strategic transactions, the company noted.

However, there were no assurance that it will lead to any agreements or transactions.

Workforce reduction :

As part of the process, Aeglea is reducing its workforce and will retain about 10 employees to support the process and continue value-creating activities.

The company announced the departure of Chief Business Officer Michael Hanley and Chief Medical Officer Linda Neuman.

"Our other clinical program, pegzilarginase for the treatment of patients with Arginase 1 Deficiency which is partnered in Europe and certain countries in the Middle East with Immedica Pharma AB, currently has a Marketing Authorization Application under review with the European Medicines Agency with a potential decision on approval in late 2023," said Chief Product Officer Cortney Caudill.

AGLE -23.88% to $0.20 premarket April 12

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