Months after Eiger Biopharmaceuticals conceded ubenimex had no effect in pulmonary arterial hypertension, the drug has proven to be a flop again — this time in lower leg lymphedema.
When compared to placebo in a Phase II study, patients on ubenimex showed no improvement in the swelling on their limbs, whether measured by skin thickness (primary endpoint) nor limb volume and bioimpedance (secondary endpoint).
While investigators in the clinic may further analyze individual patient responses that “warrant further exploration,” the Palo Alto-based biotech says it is not planning any additional clinical work unless a partner comes along, preferring instead to focus on a second set of Phase II results also announced today.
Investors are apparently happy with the glass half full, sending shares $EIGR up 11%.
With avexitide, Eiger is targeting the dangerously low blood glucose levels that some patients experience after undergoing weight loss surgery, known as post-bariatric hypoglycemia (PBH). The drug is a glucagon-like peptide-1 antagonist — in the same class as the GLP-1 drugs making waves in diabetes — dosed subcutaneously, designed to be administered by patients themselves.
“We are very pleased by the results from PREVENT, our first outpatient study of avexitide in patients suffering from PBH,” said Lisa Porter, CMO of metabolic diseases at Eiger. “Avexitide treatment led to clinically meaningful improvements consistently throughout 28-days of treatment, reducing postprandial hyperinsulinemic hypoglycemia and associated signs and symptoms.”
The whole study lasted for 42 days for the 18 patients enrolled: After 14 days of placebo injections, the patients shifted to 30 mg avexitide twice daily for 14 days, and then received 60 mg daily injections for another 14 days. Both dosing regimens hit the primary endpoint of improving postprandial glucose nadir — the lowest blood sugar point after meals — at 57.1 mg/dL (p=0.001) and 59.2 mg/dL (p=0.0002) versus the placebo number of 47.1 mg/dL. The p values were a bit more shaky for the secondary endpoint of reduced postprandial insulin peak, though Eiger claims it’s also “statistically significant with avexitide 30 mg BID (349.5 vs 454.5 μIU/mL; p < 0.03) and 60 mg QD (357.2 vs 454.5 μIU/mL; p = 0.04).”
“Eiger is advancing only the most promising programs in our pipeline for rare diseases,” said David Cory, president and CEO. “The company is now focused on advancing plans for a new drug application (NDA) in Progeria, enrollment in the first-ever Phase 3 study in hepatitis delta virus (HDV) infection, and regulatory guidance in post-bariatric hypoglycemia (PBH) in 2019.”
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