By David Bautz, PhD

NASDAQ:NRBO

READ THE FULL NRBO RESEARCH REPORT

On September 30, 2024, NeuroBo Pharmaceuticals, Inc. (NASDAQ:NRBO) announced positive topline results for the single ascending dose (SAD) Part 1 of the ongoing Phase 1 clinical trial of DA-1726 for the treatment of obesity. A total of 45 obese but otherwise healthy individuals were randomized in a double blind, 6:3 ratio to receive DA-1726 or placebo. The results showed that DA-1726 was safe, well tolerated, and had linear pharmacokinetics (PK). In regards to safety, only five subjects in the DA-1726 group reported adverse events (AEs) compared to three subjects in the placebo group. Due to the strong safety profile, at least one additional dosing cohort is being added to evaluate the maximum tolerated dose.

The multiple ascending dose (MAD) Part 2 of the trial is ongoing, with the first patient enrolled in June 2024. A total of 36 individuals are expected to be enrolled in Part 2 of the trial in a 6:3 ratio across four dosing cohorts. Each participant will receive four weekly administrations of DA-1726 or placebo. Topline results from Part 2 are expected in the first quarter of 2025.

The company continues planning for Part 3 of the trial, which we anticipate initiating in the third quarter of 2025, with an interim data readout in mid-2026 and topline results being reported in the second half of 2026. The following slide provides an overview of Part 3 of the trial, which will evaluate early proof of concept and maximum titratable dose of DA-1726.

Conclusion

As expected, the results from the SAD Part 1 of the Phase 1 trial of DA-1726 showed that the drug is well tolerated and exhibits linear PK. The fact that the company will be adding at least one additional dosing cohort is very good news as it looks to find the maximum tolerated dose. Tolerability is a key differentiating factor amongst the many obesity therapies in development, with many having been discontinued due to a high level of AEs. Thus, a highly tolerable drug could warrant considerable interest from potential commercialization partners. We look forward to the MAD results in the first quarter of 2025 as the company moves toward the initiation of Part 3 of the trial in the third quarter of 2025. With no changes to our model our valuation remains at $22 per share.

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