Ovid Therapeutics reported that its first‑ever KCC2 direct activator, OV350, completed a Phase 1 study in healthy volunteers and met all primary objectives for safety, tolerability and pharmacokinetics. The single‑ascending‑dose, randomized, placebo‑controlled trial enrolled 16 participants who received 50 mg or 100 mg of OV350 via intravenous infusion over ten minutes. No serious adverse events were observed, the safety profile was favorable, and drug exposure remained predictable up to 48 hours post‑dose.
The successful Phase 1 data de‑risk the KCC2 mechanism and provide a clinical proof‑point that will support the company’s next‑step oral candidates. Ovid’s lead oral KCC2 activator, OV4071, is slated for regulatory submission in the first quarter of 2026 and for the start of a Phase 1/1b study in the second quarter of 2026. The timing shift from the original Q1 2026 study start to Q2 2026 reflects the company’s updated development plan.
Ovid’s financial runway has been bolstered by a private placement announced in October 2025 that could raise up to $175 million. The capital is earmarked for ongoing clinical development and to support the upcoming OV4071 program. Management emphasized that the OV350 results give the company confidence in the new mechanistic class and reinforce the strategic focus on oral KCC2 activators.
The Phase 1 success positions Ovid as a potential leader in a niche therapeutic area that targets neurological and neuropsychiatric disorders characterized by neuronal hyperexcitability. By validating the KCC2 pathway, Ovid gains a competitive advantage over other companies pursuing indirect KCC2 modulation or alternative chloride transport targets.
Overall, the data strengthen Ovid’s pipeline, extend its financial runway into the second half of 2026, and provide a solid foundation for the next‑phase development of OV4071. The company’s focus on oral delivery aligns with market demand for patient‑friendly therapies and enhances the commercial potential of its KCC2 platform.
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