XOMA Corp (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. (Original Source)
Shares of Xoma are down nearly 11% to $0.595 in after-hours trading. XOMA has a 1-year high of $2.03 and a 1-year low of $0.44. The stock’s 50-day moving average is $0.61 and its 200-day moving average is $0.68.
On the ratings front, XOMA stock has been the subject of a number of recent research reports. In a report issued on August 8, Cowen analyst Phil Nadeau reiterated a Hold rating on XOMA. Separately, on August 4, Jefferies’s Biren Amin reiterated a Hold rating on the stock .
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Phil Nadeau and Biren Amin have a total average return of 3.1% and 7.7% respectively. Nadeau has a success rate of 47% and is ranked #965 out of 4151 analysts, while Amin has a success rate of 57% and is ranked #343.
XOMA Corp. is a development stage biotechnology company. It engages in the provision of discovering and developing antibody-based therapeutics. The company was founded by Patrick J. Scannon in 1981 and is headquartered in Berkeley, CA.