Spring Bank Pharmaceuticals has discontinued development of inarigivir soproxil, which was in Phase 2 development for the treatment of chronic hepatitis B virus (HBV). This decision was made in the interest of patient safety based on the occurrence of unexpected serious adverse events, including one patient death, in Spring Bank’s Phase 2b CATALYST trial.
“We are deeply saddened by the death of a patient in our CATALYST 2 trial. Because we are guided by an overriding interest in protecting patients, we have made the difficult decision to discontinue the further development of inarigivir for the treatment of HBV at Spring Bank,” said Martin Driscoll, President and CEO of Spring Bank. “We will continue to work in close collaboration with external experts and our clinical study investigators to provide the care necessary for all study patients and will continue to conduct a series of investigative actions to better understand the unexpected serious adverse events observed in our Phase 2b program.”
Spring Bank will not pursue further research and development efforts in HBV but will continue to focus on new treatments for diseases with high unmet needs in the therapeutic fields of immuno-oncology and inflammation. These efforts will primarily include the advancement of the lead product candidate from the company’s novel STING agonist platform, the intravenously (IV)-administered SB 11285, which is currently in a Phase 1a/1b trial.
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“We will devote our resources to advancing multiple programs in our STING product portfolio, including our SB 11285 IV STING agonist clinical program in oncology, our STING antagonist compounds for inflammatory diseases, and our STING agonist ADC program,” Driscoll said. “By the end of 2020, we plan to generate sufficient data from our Phase 1a/1b IV STING agonist program to enable advancement into a Phase 2 clinical trial, initiate IND-enabling activities for an orally-available STING antagonist and progress our pipeline of STING agonist ADCs.”
In accordance with the decision to discontinue the further development of inarigivir and all HBV drug development, Spring Bank will not invest further resources towards the company’s chimeric oligonucleotide antisense (CASO) program for HBV, and has initiated discussions with external parties for licensing of this program. As a result of the elimination of costs related to its HBV program, the company believes that its cash position of $54.5 million as of December 31, 2019 (unaudited) will fund the company’s new operating plan into late 2022.