Spherix (NASDAQ:SPEX) surged nearly 64% premarket Thursday after the company said its treatment for Type 2 diabetes showed “statistically significant” clinical results.
In the phase III study, Spherix’s monotherapy D-tagatose significantly reduced levels of glycated hemoglobin, or HbA1c, a protein in red blood cells formed when blood sugar attaches to hemoglobin, at 10 months of treatment in relatively healthy people with diabetes.
While lower levels of HbA1c in the blood are considered normal, high levels often lead to a diabetes diagnosis.
Patients in the study had an average HbA1c of 7.5%, higher than the level considered normal of 6%. The American Diabetes Association recommends reducing HbA1c to 7% or below in people with diabetes.
The reduction shown in the NEET trial was even more pronounced among PP (per-protocol) patients treated in the US, the company said.
“These are promising results and we are pleased with the significant drop in HbA1c levels among patients treated with Dtagatose,” said Spherix CEO Dr. Claire Kruger. “As a monotherapy in a patient population with mild disease, this achievement is even more compelling.”
Tolerability data are still being analyzed, though the company said the number of patients with one or more adverse effects from the treatment were comparable to those reported in the placebo group.
Spherix said it plans to begin discussions with pharmaceutical companies and is participating in BioPartnering Europe this month in London and the Windhover Therapy Area conference next month in Boston.