Kamada Ltd. (Nasdaq: KMDA); TASE: KMDA) has reported positive results in the extension study of a Phase I/II clinical trial with its lead product Glassia for the treatment of pediatric patients with a recently diagnosed type 1 diabetes.In type 1 diabetes, the ability of pancreatic cells to produce insulin is compromised, and, with time, progressive deterioration of beta-cell reserve occurs due to the continuous autoimmune attack. New interim data from the ongoing extension study showed that 20 months from diagnosis of type 1 diabetes and 10 months following the last Glassia infusion, 60% of study subjects who participated (12/20) in the extension portion of the Phase I/II trial had peak C-peptide levels greater than 0.2 pmol/ml (average >0.4 pmol/ml), which indicates a functioning beta cell capacity, and is a higher percentage than expected without intervention.
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In addition, patients continued to attain International Society for Pediatric and Adolescent Diabetes (ISPAD) treatment targets with an average hemoglobin sugar level (HbA1C) of 7.5%, and the majority of patients (75%) presented HbA1C levels even lower than 7.5%, which is the clinically desired level for glycemic control in pediatric diabetic patients who usually demonstrate a more severe or volatile form of T1D disease compared with adults.
No safety issues were reported
Kamada CEO David Tsur said, “We are delighted that these interim data from the extension study continue to demonstrate the positive signals seen in our analysis of study results. These positive data may potentially represent a breakthrough in the treatment of this disease, and encourage us to actively move forward with plans to advance the clinical development of Glassia in this indication.
“Importantly, the preservation of beta cells may allow patients to reduce dependence on external insulin and eventually decrease disease complications such as cardiovascular disease, kidney failure, eye disease, severe wounds and more. These complications remain an unmet need that is still inadequately answered with existing therapies, which include insulin, diet and behavioral treatment.”
Kamada plans to initiate a Phase II/III trial with Glassia with newly diagnosed type one diabetes pediatric and young adult patients in Israel by the end of the year to test Glassia’s efficacy in stopping the progression on the disease and maintaining the pancreas’s ability to produce insulin. The company may expand the study to other countries.