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news.Islet Sciences, a development stage biotechnology company, has signed a binding letter of intent to acquire Brighthaven Ventures d/b/a BHV Pharma.
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BHV is a privately held pharmaceutical company developing the SGLT2 inhibitor remogliflozin etabonate (remogliflozin) for type 2 diabetes and non-alcoholic steatohepatitis (NASH). Remogliflozin is currently in Phase II clinical development.
Islet Sciences CEO James Green the acquisition of BHV is the first step in transitioning Islet into a clinical-stage growth company.
"SGLT2 inhibitors are an important new class of drugs for the treatment of type 2 diabetes, and we see remogliflozin emerging as the most positively differentiated molecule in the class. As an anti-diabetic, remogliflozin is very compelling, but we are also very excited about the NASH indication where remo’s chemistry gives us a unique advantage," Green added.
In exchange for 100% ownership of BHV, Islet Sciences will issue 30 million shares of Islet Sciences common stock to holders of BHV units. Additional shares of Islet common stock will be issued upon successful completion of development, regulatory and commercial milestones associated with the remogliflozin program.
SGLT2 inhibitors (sodium-glucose co-transporter 2 inhibitors) control glucose levels in patients with diabetes by blocking reabsorption of glucose in the kidney resulting in reduced blood sugar and A1c levels.
They are the only oral anti-diabetics that provide significant HbA1c lowering with clinically relevant weight loss through an insulin-independent, beta-cell sparing mechanism of action. SGLT2 inhibitors control glucose levels in patients with diabetes.
Remogliflozin is a highly selective SGLT2 inhibitor in Phase II clinical development for type 2 diabetes and NASH. It has been dosed in over 800 subjects in more than 20 clinical trials. In 12-week phase 2b clinical studies, remogliflozin demonstrated HbA1c lowering greater than 1% with no significant adverse events and low incidence rates of genitourinary infections, a common side effect associated with SLGT2 inhibitors.
Remogliflozin also demonstrated strong postprandial glucose disposal and improvements in both insulin sensitivity and beta cell function. In patients with impaired renal function, remogliflozin pharmacokinetics and pharmacodynamics were not affected and, therefore, no dose adjustment is expected for this large (> 35%) segment of the diabetic population.