XOMA Corp. (XOMA), involved in the discovery and development of therapeutic antibodies, reported intermediate success in its ambitious XOMA 358 Phase 2 studies targeted towards treating patients who develop complications from abnormal functioning of insulin which include severe cases of hypoglycemia due to congenital hyperinsulinism (CHI) and post-bariatric surgery (PBS). (See also: Analysts Battle Over Mannkind—But Who's Right?)
XOMA’s first-in-class allosteric antibody demonstrated the desired mechanism-of-action by inhibiting upon insulin signaling. This indicates that the drug is effective in preventing hypoglycemic episodes for patients who have challenges in regulating their insulin levels or face severe attacks of hypoglycemia. These occurrences are observed in patients having congenital hyperinsulinism and with certain cases of post-bariatric surgery.
The ongoing CHI study uses progressive doses of XOMA 358 and gauges various parameters which include the safety measures and pharmacokinetic, pharmacodynamics and biological activities.
While the trial set is small, comprising a limited number of patients, encouraging results from the ongoing study will assist in defining a new set of parameters for improving drug efficiency, like the use of continuous glucose monitoring to track a patient's glycemic profile over days and weeks. The drug also fared well on safety and tolerance parameters without any reports of adverse events.
XOMA 358 has the potential to mitigate insulin-induced disorders safely and effectively. Considering the unmet medical need for treating insulin-related abnormalities which affect a wide variety of patients including infants and young children, XOMA’s offering can be a game-changer.
Providing the update, Chief Executive Officer of XOMA John Varian expressed confidence in the company's progress, and stated that “we believe XOMA 358 is ready for advancement into Phase 2b multi-dose studies” considering “the totality of preclinical and clinical evidence.”