Northstrive Biosciences (NSTB) Plans Phase 2 Study After Positive FDA Feedback | ELAB Stock News

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Apr 24, 2025

Northstrive Biosciences has received encouraging preliminary feedback from the U.S. Food and Drug Administration (FDA) concerning its upcoming Type B pre-Investigational New Drug (IND) meeting, originally intended to discuss the company’s clinical development strategy for EL-22. The discussions centered on the drug's nonclinical studies and its combination with GLP-1 receptor agonists. Following the FDA's preliminary response, Northstrive is confident in proceeding with an IND application for a Phase 2 clinical trial.

The FDA's preliminary assessment suggests that the pharmacology studies sufficiently demonstrate the activity of EL-22, and the nonclinical studies seem adequate to ensure its safety and effectiveness for overweight and obese populations. Additionally, data from Northstrive's Phase 1 study and completed nonclinical trials provide a strong foundation for moving forward with the proposed Phase 2 trial.

As a result of the positive preliminary feedback, Northstrive Biosciences (NSTB) plans to bypass the pre-IND meeting, given that the responses were deemed sufficient. The company is preparing to submit the IND application by 2025, with the goal of initiating the Phase 2 clinical trial soon after. This trial will focus on assessing the efficacy of EL-22 in combination with GLP-1 receptor agonists for obesity treatment.

Currently, Northstrive is actively collaborating with Current Good Manufacturing Practices (CGMP) partners to ensure the production readiness of EL-22, underscoring the company's commitment to advancing this promising treatment option.

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I/We may personally own shares in some of the companies mentioned above. However, those positions are not material to either the company or to my/our portfolios.