NEW YORK - Ovid Therapeutics Inc . (NASDAQ: NASDAQ:OVID) and Graviton Bioscience Corporation have announced positive results from a Phase 1 study of OV888/GV101 capsule, a potential treatment for cerebral cavernous malformations (CCM). The study met its primary objective, showing a favorable safety and tolerability profile with no serious adverse events reported.
The trial, which was a randomized, placebo-controlled study involving multiple ascending doses, indicated that the pharmacokinetic profile of OV888/GV101 supports once-daily dosing. The capsule was also found to be biologically active, eliciting dose-dependent pharmacodynamic effects within the planned therapeutic dose range.
Secondary endpoint results revealed that the target pharmacokinetic profile was achieved at the targeted clinical dose. The most commonly reported clinical adverse event was headache, occurring in 23% of participants, all of whom experienced transient cases that resolved without intervention.
Laboratory findings during the study period showed two asymptomatic laboratory findings rated Grade 2 or higher, which occurred in at least 5% of treated subjects relative to placebo. These included increases in total bilirubin and creatine phosphokinase, both of which were deemed clinically insignificant and resolved during the study period.
The companies plan to advance to a Phase 2 clinical study in the second half of 2024, which will further investigate OV888/GV101's efficacy in treating CCM—a condition that currently has no FDA-approved pharmacologic treatments and is often managed by "watchful waiting" or high-risk brain surgery.
Dr. Jeremy Levin, Chairman and CEO of Ovid Therapeutics, expressed optimism about the potential of the capsule to become the first oral treatment for CCM. Dr. Samuel Waksal, CEO of Graviton, highlighted the capsule's potential three-pronged effect on CCM, aiming to restore brain endothelial cell barrier function, reduce inflammation, and stop fibrosis in lesions.
CCMs are vascular malformations in the central nervous system that can lead to headaches, seizures, and other neurological deficits. OV888/GV101 capsule, a selective ROCK2 inhibitor, has shown promise in preclinical studies for its ability to penetrate the blood-brain barrier and selectively target ROCK2, a pathway important for vascular endothelial function.
This news is based on a press release statement and has not been independently verified. The companies are continuing to explore the therapeutic potential of inhibiting ROCK2 in various neurovascular and neuro-inflammatory conditions.
In other recent news, Ovid Therapeutics Inc. has encountered a series of financial adjustments following the results of clinical trials for its investigational drug, Soticlestat. Despite the trials not meeting primary endpoints for Dravet syndrome and Lennox-Gastaut syndrome, significant effects were observed in secondary endpoints.
TD (TSX:TD) Cowen, maintaining its Buy rating on the company, noted these effects. In response to the trial results, Ovid has committed to prioritizing its programs strategically to extend its cash runway into the first half of 2026.
Analyst firms have made various adjustments in their outlooks on Ovid. H.C. Wainwright reduced its price target to $3.00, while BTIG and B.Riley also lowered their share target prices, all maintaining Buy ratings. Oppenheimer, however, downgraded the stock from Outperform to Perform.
The company, together with its partner Takeda, is currently assessing the next steps for Soticlestat's development. The detailed findings from these recent studies are expected to be presented at the American Epilepsy Society meeting in December.
Despite the challenges faced in the trials, Ovid reported surpassing earnings per share estimates, a key financial indicator closely watched by investors. These recent developments highlight the ongoing efforts of Ovid Therapeutics in advancing its drug development pipeline and securing its financial position.
InvestingPro Insights
As Ovid Therapeutics Inc. (NASDAQ: OVID) announces promising results from its Phase 1 study, the financial metrics and market sentiment around the company provide additional context for investors.
With a market capitalization of $54.57 million, Ovid Therapeutics is navigating the biotech space with significant revenue growth over the last twelve months as of Q1 2024, boasting an impressive 283.93%. This growth is further underscored by a quarterly revenue increase of 124.24% in Q1 2024, signaling strong performance in the company's operations.
Still, the company's current financial health shows a P/E ratio of -1.04, aligning with the fact that Ovid has not been profitable over the last twelve months. While the company holds more cash than debt on its balance sheet, an InvestingPro Tip highlights that Ovid is quickly burning through cash, which could be a concern for long-term sustainability. Moreover, analysts have revised their earnings upwards for the upcoming period, reflecting a potential positive shift in the company's financial trajectory.
InvestingPro Tips also reveal that the stock has experienced high price volatility and has seen a significant price decline over the past year, with a 76.55% drop in the one-year price total return as of mid-2024. The stock is currently trading at 18.58% of its 52-week high, and the relative strength index (RSI) suggests that the stock is in oversold territory, which could interest investors looking for potential entry points.
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