Shares of clinical-stage biopharmaceutical company Spring Bank Pharmaceuticals, Inc. (SBPH - Free Report) plummeted 66.8% after it stopped dosing and enrolling patients in its mid-stage studies on lead product candidate, inarigivir.
The phase IIb CATALYST studies are evaluating inarigivir soproxil 400mg for the treatment of chronic hepatitis B virus (HBV). The candidate is designed to activate within hepatic cells retinoic acid-inducible gene 1 (RIG-I), which has been shown to inhibit HBV viral replication and induce the intracellular interferon signaling pathways for antiviral defense.
However, the company decided to stop the dosing of inarigivir 400mg in the CATALYST studies after observing clinical findings from the CATALYST 2 study of virally-suppressed chronic HBV patients. Three subjects participating in this study showed evidence of hepatocellular dysfunction and an elevation of alanine transaminase (ALT), potentially consistent with liver injury rather than immune flares. Spring Bank is evaluating and analyzing the data. The company is further evaluating safety data across almost 100 patients who have received inarigivir at this dose.
Additionally, the company has stopped dosing and enrollment in all other studies of inarigivir in subjects with chronic HBV.
The news disappointed investors as inarigivir is the company’s lead candidate and the successful development of the same would have boosted its growth prospects. Spring Bank’s stock has plunged 88.5% in the year so far compared with the industry's growth of 10.3%.
We note that the company has entered into a clinical trial supply and collaboration agreement with Gilead Sciences, Inc. (GILD - Free Report) that has been subsequently amended. Per the deal, Gilead is funding and conducting a phase II study evaluating inarigivir (50mg, 200mg and 400mg) co-administered with Vemlidy 25 mg (tenofovir alafenamide) in patients infected with chronic HBV. Interim top-line results were positive.
Other FDA-approved treatments for patients with chronic HBV include Bristol-Myers Squibb Company’s (BMY - Free Report) Baraclude. In October, Arbutus Biopharma Corporation (ABUS - Free Report) discontinued the clinical development of AB-506, an oral capsid inhibitor for the treatment of chronic hepatitis B.
Apart from inarigivir, Spring Bank is developing its lead STING agonist product candidate, SB 11285, an immunotherapeutic agent for the treatment of selected cancers.
Spring Bank currently carries a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
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