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358 update

358 update for CHI and hypoglycaemia post-op

Congenital Hyperinsulinism Phase 2 study completed and multi-dose study protocol approved in UK
Company initiates multi-dose study in hypoglycaemic post-bariatric surgery patients

Xoma has established proof-of-concept for its product candidate 358 in congenital hyperinsulinism (CHI) and hypoglycaemia post-bariatric surgery (PBS). The CHI acute studies have met their objectives of establishing initial safety and 358 proof-of-concept in CHI patients aged 12 and up across several dosing levels. The company is nearing the launch of a multi-dose study in children with CHI aged 2 and up that will be conducted in the UK. The PBS study has completed dosing in the single-dose cohorts and has also met its objectives; a multi-dose study has been initiated.

"With the large unmet clinical need in patients with CHI and PBS, 358 provides a first-in-class antibody with the potential to help paediatric and adult patients properly regulate their blood glucose concentrations and prevent hypoglycaemic episodes," said Dr Eric P Brass, Professor Emeritus of Medicine, David Geffen School of Medicine, University of California, Los Angeles. "These data clearly demonstrate that a single-dose of 358 results in predictable and reproducible pharmacokinetics and meaningful improvements in glucose concentrations. The Company can now assess, in follow-on studies, the consistency and magnitude of 358's effect through multi-dose protocols to yield sustained steady-state drug exposure in the target populations."

CHI is a rare disease that results in the sustained over production of insulin and usually presents early in life. Parents and children living with CHI are required to be hyper vigilant to ensure the child's blood glucose level does not fall below a critical threshold as they face the risk of seizures and long-term cognitive impairment.

358 is a fully human negative allosteric modulating insulin receptor antibody derived from the XMet platform. It is being investigated as a novel treatment for non-drug-induced, endogenous hyperinsulinemic hypoglycaemia (low blood glucose caused by excessive insulin production), as well as hypoglycaemia after bariatric surgery.

358 has been designated an orphan drug intended for the treatment of CHI in the US and European Union. Post-bariatric surgery patients are also at risk for debilitating episodes of hypoglycaemia. Of the nearly 67,000 patients each year that undergo the Roux-en-Y method of bariatric surgery, approximately five percent will develop severe hypoglycaemia. Severe hypoglycaemia can have a significant impact on a patient's health and ability to participate in the normal activities of daily life. 

"There are thousands of children and adults worldwide who are living with hyperinsulinemic hypoglycaemia," said Dr Jim R Neal, CEO of Xoma. "When we consider the totality of preclinical and clinical evidence, we are confident proof-of-concept has been established for 358. It inhibits insulin signalling by binding to the insulin receptor in an allosteric manner and the antibody appears to be safe and well tolerated. It is clear that 358 is ready to move into multi-dose studies."

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