Surrozen Abandons IBD Treatment SZN-1326

Surrozen finds itself at a crossroads in its pursuit of a treatment for inflammatory bowel disease (IBD), as challenges in determining a safe and effective dosage have compelled the biotech company to terminate further development of its IBD therapy SZN-1326. 

The intricacies of dose calibration, combined with the fiercely competitive landscape within the pharmaceutical market, prompted this strategic shift, marking a significant development for Surrozen and its pipeline geared toward tackling IBD.

The recent announcement comes in the wake of complications observed in the healthy volunteer trial of SZN-1326, involving 37 participants. Notably, a subset of subjects experienced asymptomatic yet notable elevations in liver enzymes, a potential signal of hepatic injury. 

Of particular concern were the four subjects exhibiting grade 3 increases in alanine aminotransferase (ALT) and aspartate aminotransferase (AST), with three of these cases having been previously disclosed by the company. The decision to halt the trial was made when Surrozen first identified these concerning side effects.

In the aftermath of the trial pause, diligent investigations by the company have revealed that no additional “clinically significant” abnormalities in laboratory parameters have surfaced. Intriguingly, the heightened liver enzymes spontaneously returned to baseline levels without necessitating any specific intervention, adding a layer of complexity to the understanding of the observed adverse effects.

The administered doses in the phase 1 trial encompassed a spectrum from 0.01 mg to 25 mg. While the lower doses demonstrated a commendable safety profile, Surrozen, exhibiting a cautious approach, expressed reservations about their potential efficacy in addressing the intricacies of IBD.

Shifting gears in its strategic approach, Surrozen is redirecting its immediate focus towards SZN-043, a promising alternative that has recently concluded its enrollment phase in a comprehensive phase 1a trial. 

This trial included both healthy volunteers and individuals afflicted with chronic liver disease, aiming to provide a broader understanding of the safety and pharmacodynamic profile of SZN-043. Anticipation is high as the company expects to unveil critical data in these domains during the initial quarter of this calendar year. 

Moreover, the impending initiation of the phase 1b segment, focusing on patients with alcohol-associated hepatitis, is poised to commence shortly, potentially yielding pivotal proof-of-concept data by the latter half of 2024.

Craig Parker, the President and CEO of Surrozen, emphasized the pivotal role of SZN-043 in the company’s evolving narrative. Distinguishing itself with a unique antibody technology and a distinctive approach to modulating Wnt signaling, SZN-043 represents a fresh perspective in Surrozen’s quest for innovative therapeutic solutions.

Looking ahead, Surrozen holds another promising asset in its collaborative venture with Boehringer Ingelheim—SZN-413. This collaborative effort, centered on addressing retinal damage, awaits its turn to formally request regulatory approval to initiate human trials. The company has not disclosed a specific timeline for this crucial step. 

The post Surrozen Abandons IBD Treatment SZN-1326 appeared first on LifeSci Voice.