XOMA (XOMA) Updates on XOMA 358 Phase 2; PBS Study Showed Some Effect on Glucose, Insulin

September 16, 2016 6:05 AM EDT

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XOMA Corporation (Nasdaq: XOMA) provided an update on its ongoing XOMA 358 Phase 2 studies in patients with severe hypoglycemia due to congenital hyperinsulinism (CHI) and post-bariatric surgery (PBS), two rare conditions resulting from abnormal insulin function. The following is a summary of its clinical progress related to XOMA 358 as reported in a webcast and conference call held earlier today.

“The initial data from the XOMA 358 Phase 2 clinical studies confirms that our first-in-class allosteric antibody is exhibiting an inhibition on insulin signaling, the desired mechanism-of-action. This means that for patients who are not able to properly regulate their high insulin levels and experience severe bouts of hypoglycemia, such as those diagnosed with congenital hyperinsulinism and certain post-bariatric surgery patients, XOMA 358 could provide benefit in preventing hypoglycemic episodes,” stated John Varian, Chief Executive Officer of XOMA. “When we consider the totality of preclinical and clinical evidence, which demonstrates that XOMA 358 down-regulates insulin signaling by binding to the insulin receptor in an allosteric manner, we believe XOMA 358 is ready for advancement into Phase 2b multi-dose studies.

“I want to thank these patients for their willingness to participate in these studies,” Mr. Varian concluded.

XOMA 358 Initial Combined Phase 2 Clinical Data

Patients act as their own control. To confirm their baseline status and participate in the ongoing Phase 2 studies, each patient must have two documented hypoglycemic events, captured by continuous glucose monitoring (CGM) or by supervised provocation by fast, protein challenge or meal test.

The ongoing CHI study is designed to evaluate the safety, pharmacokinetic, pharmacodynamics and biological activity of escalating doses of XOMA 358. Preliminary data from seven patients showed reduced duration and number of hypoglycemic episodes with increasing dose.

In the Phase 2 PBS study, XOMA 358 showed some effect on glucose and insulin tolerance in the face of a meal challenge at the initial dose of 3 mg/kg in two patients.

“We believe the most relevant efficacy measures are the duration of hypoglycemia and the number of hypoglycemic episodes. Although the number of patients dosed with XOMA 358 is small, both time spent in a hypoglycemic state, and number of hypoglycemic episodes decreased in a dose-dependent manner. We will continue to further confirm this type of drug effect in additional patients,” commented Paul Rubin, MD, Senior Vice President Research and Development and Chief Medical Officer of XOMA. “The data from our ongoing Phase 2 study is helping us define the parameters that will give us the best opportunity for demonstrating efficacy in future studies, such as the use of continuous glucose monitoring to track glycemic profile on a continuous basis over days and weeks.”

The update presented by the Company represents data from twenty-two healthy volunteers, seven CHI patients and two PBS patients receiving XOMA 358. XOMA 358 appears to be safe and well tolerated. Reported Treatment-Emergent Adverse Events were mostly mild and primarily related to insulin administration from the Insulin Tolerant Test in the Phase 1 trial. No Serious Adverse Events have been reported.

The Company anticipates enrolling a total of 12 to 15 CHI patients and up to 20 PBS patients with the majority tested at an active dose of XOMA 358.

A replay of the webcast, along with the slide presentation, can be accessed via the Investors and Media section of XOMA's website at http://investors.xoma.com/events.cfm and will be available for replay until close of business on December 15, 2016.

About XOMA Phase 2 Proof-of-Concept Studies

The open-label, single-administration studies evaluate XOMA 358 in patients with congenital hyperinsulinism (CHI) and patients with hypoglycemia post-bariatric surgery (PBS). The CHI study is open for patient enrollment at the Children's Hospital of Philadelphia (CHOP), and clinical sites located in London, England and in Magdeburg, Germany. The PBS study is open for enrollment at Johns Hopkins University in Baltimore, the Joslin Clinic in Boston and the Mayo Clinic in Rochester, MN. Additional sites are expected to open in the coming months.

In addition to monitoring safety throughout the studies, serial blood samples are being collected for pharmacokinetic and pharmacodynamic assessments. Various markers of drug activity are being assessed, including changes in glucose, ketones, insulin, C-peptide and free fatty acid levels. Controlled tests include monitored fasts, protein challenges, and oral glucose tolerance.

About XOMA 358

Insulin is the major physiologic hormone for controlling blood glucose levels. Abnormal increases in insulin secretion can lead to profound hypoglycemia (low blood sugar), a state that can result in significant morbidities, including brain damage, seizures and epilepsy. XOMA, leveraging its scientific expertise in allosteric monoclonal antibodies, developed the XMet platform, consisting of separate classes of selective insulin receptor modulators (SIRMs) that could have a major effect on treating patients with abnormal metabolic states.

XOMA 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 hypoglycemia (low blood glucose caused by excessive insulin production), as well as hypoglycemia after bariatric surgery and other related disorders. XOMA is conducting Phase 2 development activities for XOMA 358 in patients with congenital hyperinsulinism (CHI) and in patients with hypoglycemia post-bariatric surgery (PBS). A therapy that safely and effectively mitigates insulin-induced hypoglycemia has the potential to address a significant unmet therapeutic need for certain rare medical conditions associated with hyperinsulinism. More information on the XOMA 358 clinical trial may be found at www.clinicaltrials.gov and www.clinicaltrialsregister.eu.

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