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Biotech to Advance New Type 1 Diabetes Drug Into Clinic

Source: Edward White


October 24, 2023 ( Newswire) Dosing of the first patient is expected in Q4/23 in this Phase 1 trial to be done in Australia, noted an H.C. Wainwright & Co. report.

SAB Biotherapeutics Inc. (SABS:NASDAQ) got a greenlight from the Australian Human Research Ethics Committee to conduct a Phase 1 clinical trial of SAB-142, an immunotherapy targeting type 1 diabetes, reported H.C. Wainwright & Co. analyst Edward White in an October 19 research note.

"SAB-142 is a first-in-class, fully human, anti-thymocyte globulin being developed for delaying the onset of type 1 diabetes," White wrote.

223% Possible Return

Given the news, H.C. Wainwright reiterated its US$2 per share target price on the South Dakota-based biotech, trading now at about US$0.62 per share.

The difference between the current share price and the target price reflects a significant possible gain for investors of 223%.

SAB remains a Buy.

About the Study

The Phase 1 trial, to be conducted in Australia, will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of SAB-142.

The study will be double-blind and placebo-controlled. It will enroll about 40 healthy adult volunteers who will be randomized into five cohorts, eight people per group. Cohort 1 will be randomized at a 2:1 ratio, while the other groups will be randomized on a 3:1 basis.

The study will evaluate five doses of SAB-142 in ascending fashion: 0.03 milligrams per kilogram (0.03 mg/kg), 0.1m/kg, 0.5mg/kg, 1.5mg/kg, and 2.5mg/kg.

The time commitment for each participant is a maximum of 232 days. This period will include a 45-day screening component, a seven-day confinement, and a 173-day follow-up.

Adaptive Arm Included

White reported that the Phase 1 study includes an adaptive arm. This means that if the protocol-defined, adaptive criteria are met among the healthy volunteers, as determined by the safety review committee after examining clinical lab results, adverse events, and other data, then the trial will transition to patients with type 1 diabetes.

During this shift, the dosing of healthy volunteers will cease. In their place, type 1 diabetes patients will be enrolled, six per cohort, in a randomized fashion on a 2:1 basis and dosed.

Dates of Milestones

White outlined the anticipated timing of events up to and beyond regulatory approval.

Soon, SAB plans to file an investigative new drug application (IND) with the U.S. Food and Drug Administration for SAB-142.

IND approval, followed by the first dosing of a human patient, is expected to happen in Q4/23.

Looking further ahead, H.C. Wainwright forecasts a commercial launch of SAB-142 in 2029 and US$75 million (US$75M) in sales that year, increasing to US$200M in 2030.

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