Phase 2 Study to Examine Novel Combination Hepatitis B Treatment

Selective oral immunomodulator plus tenofovir alafenamide (Vemlidy) seeks functional cure in chronic HBV.

A phase 2 clinical trial is underway to examine the combination treatment of the novel, selective oral immunomodulator SB 9200 plus tenofovir alafenamide (Vemlidy) in patients with chronic hepatitis B virus (HBV).

Despite the availability of vaccinations against HBV, an estimated 257 million individuals are living with the virus worldwide. Now, Spring Bank Pharmaceuticals is collaborating with Gilead Sciences to launch a trial aimed at finding a functional cure in the treatment of chronic HBV, according to a press release.

SB 9200 is designed to activate hepatic retinoic acid-inducible gene 1 (RIG-I) to treat chronic HBV.

“We are excited to be starting a new phase 2 trial, which will be funded and implemented by Gilead Sciences and has the potential to accelerate the development program of SB 9200 as a potential backbone therapy for treatments focusing on functional cure in HBV,” Nezam Afdhal, MD, DSc, chief medical officer of Spring Bank, said in the release.

Spring Bank released top-line results from the initial cohort of the Phase 2a segment of the ACHIEVE trial in May 2017. The findings suggest that a 25 mg dose of SB 9200 alone may reduce hepatitis B surface antigen (HBsAg) levels in patients with chronic HBV.

“We hope the combination of SB 9200 with Vemlidy will be synergistic in reducing HBsAg,” Dr Afdhal said. “This clinical trial partnership with Gilead is a continuation of our strategic efforts to engage in collaborations involving the study of SB 9200 in combination with other compounds against chronic HBV, and is an important step in defining the most rapid path to potential phase 3 development of new combination strategies for functional cure of HBV.”

Many nations are beginning to explore targeted HBV-vaccination programs for individuals who are at high-risk for HBV. One study found that HBV vaccination programs are cost-effective in certain high-risk populations. Furthermore, research suggests that many countries would save health care dollars if they vaccinated earlier.

Current treatment options for HBV include entecavir (Barraclude) and tenofovir (Viread), direct-acting antivirals that suppress viral replication. Global revenues for these drugs were approximately $2.6 billion in 2016, according to Spring Bank.