MIAMI - The U.S. Food and Drug Administration (FDA) has cleared SAB Biotherapeutics' investigational new drug (IND) application for a Phase 1 clinical trial of SAB-142, a potential therapy for type 1 diabetes (T1D), the company announced today.
The clinical-stage biopharmaceutical company, which specializes in novel immunotherapy platforms, is developing SAB-142 as a human anti-thymocyte immunoglobulin (hIgG) aimed at slowing the onset or progression of T1D.
This regulatory clearance paves the way for patient enrollment in the United States for the HUMAN trial. The trial is a first-in-man study designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenous SAB-142 in healthy volunteers and participants with T1D. The trial is a randomized, double-blind, placebo-controlled, single-ascending dose study with an adaptive design.
Samuel J. Reich, Chairman and CEO of SAB, expressed enthusiasm about the FDA's decision, stating that it represents a significant advancement in the company's efforts to develop disease-modifying therapies for T1D.
The Phase 1 trial aims to establish the safety profile of SAB-142 and validate its mechanism of action in humans. An update on April 16 indicated that the third cohort has been fully enrolled and dosed without observed serum sickness, a common adverse reaction associated with animal-derived ATG treatments.
SAB-142 differentiates itself as a human alternative to rabbit anti-thymocyte globulin (ATG), which has shown efficacy in slowing T1D progression by modulating the immune response to preserve insulin-producing beta cells. However, rabbit ATG often leads to serum sickness and anti-drug antibodies in humans. SAB-142 seeks to offer a human biologic treatment option that could potentially allow for safe, consistent re-dosing without these adverse immune reactions.
The company's DiversitAb™ platform, which utilizes Transchromosomic (Tc) Bovine™, facilitates the generation of targeted, high-potency human immunoglobulins without the need for human donors or convalescent plasma.
This article is based on a press release statement from SAB Biotherapeutics.
InvestingPro Insights
As SAB Biotherapeutics (SABS) advances with its clinical trials for SAB-142, the company's financial metrics and market performance provide a broader context for investors following its journey. According to real-time data from InvestingPro, SAB Biotherapeutics holds a market capitalization of $31.83 million, with a significant gross profit margin of 76.2% over the last twelve months as of Q1 2024. Despite a notable revenue decline of 79.48% in the same period, the company showed a substantial quarterly revenue growth of 62.55% in Q1 2024.
An InvestingPro Tip worth noting is that SAB Biotherapeutics holds more cash than debt on its balance sheet, which could be a sign of financial stability. Additionally, the company's stock is currently trading near its 52-week low and the RSI suggests it is in oversold territory, which could potentially interest value investors looking for entry points.
Investors considering SAB Biotherapeutics as an investment should be aware that analysts do not anticipate the company will be profitable this year, and the stock has experienced significant declines over the last week, month, and six months. However, the company’s liquid assets exceed short-term obligations, which may provide some level of reassurance regarding its short-term financial health.
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