LOS ALTOS, Calif. - Unicycive Therapeutics, Inc. (NASDAQ: UNCY), a biotech firm focusing on kidney disease treatments, today announced the completion of its UNI-494 Phase 1 study. The trial, which involved healthy volunteers, aimed to evaluate the safety, tolerability, and pharmacokinetics of the drug, potentially paving the way for a Phase 2 trial in patients with acute kidney injury.
The study comprised two parts: a single ascending dose phase with 40 participants and a multiple ascending dose phase with 19 participants. In the single dose phase, 30 participants received UNI-494 with doses ranging from 10 mg to 160 mg, and 10 received a placebo. No serious adverse events or withdrawals due to adverse events were reported, with headache being the most common side effect.
In the multiple dose phase, participants received 40 mg or 80 mg twice daily for 5 days. The 40 mg dose was well-tolerated, but the 80 mg dose led to four participants withdrawing due to adverse events, including headache, nausea, and vomiting. The study found that UNI-494 was rapidly metabolized, releasing nicorandil and the linker as expected, with plasma concentration of nicorandil increasing slightly more than proportionally with the dose.
These results will inform the dosage and scheduling for a potential Phase 2 clinical trial. Unicycive plans to discuss these findings with the FDA before the year's end and will present further details at an upcoming scientific conference.
UNI-494 is a novel nicotinamide ester derivative designed to activate ATP-sensitive mitochondrial potassium channels. Mitochondrial dysfunction is a key factor in the progression of acute kidney injury and chronic kidney disease, and UNI-494's mechanism aims to restore mitochondrial function. The drug has been granted orphan drug designation by the FDA for preventing Delayed Graft Function in kidney transplant patients.
Acute kidney injury is a critical condition characterized by a rapid loss of kidney function, affecting a significant portion of hospital and intensive care unit patients and associated with high morbidity and mortality rates.
Unicycive Therapeutics is also developing other treatments for kidney diseases, including a phosphate binding agent for hyperphosphatemia in chronic kidney disease patients on dialysis. This news is based on a press release statement from the company.
In other recent news, Unicycive Therapeutics has made significant strides in its clinical trials. The company has submitted a New Drug Application (NDA) for Oxylanthanum Carbonate (OLC), a treatment for hyperphosphatemia in chronic kidney disease patients on dialysis. This submission has been backed by data from three clinical studies and additional preclinical data. Benchmark has maintained a Speculative Buy rating on Unicycive, while H.C. Wainwright adjusted its stock price target to $2.50.
Unicycive has also secured a U.S. patent for UNI-494, a compound aimed at treating acute kidney injury. Despite these advancements, Unicycive faces potential delisting from the Nasdaq Market due to non-compliance with the exchange's listing rules. Noble Capital and Piper Sandler have maintained their positive ratings for Unicycive. These are the recent developments in Unicycive Therapeutics' journey.
InvestingPro Insights
As Unicycive Therapeutics (NASDAQ: UNCY) advances its kidney disease treatments, investors should consider some key financial metrics and expert insights. According to InvestingPro data, the company's market capitalization stands at $34.25 million, reflecting its current position in the biotech sector.
InvestingPro Tips highlight that Unicycive holds more cash than debt on its balance sheet, which could be crucial for funding further clinical trials and research. This financial stability is particularly important given that the company is "quickly burning through cash" as it progresses its drug development pipeline.
The company's stock has taken a significant hit over the last six months, with a price total return of -72.73%. This volatility aligns with another InvestingPro Tip noting that "stock price movements are quite volatile," which is not uncommon for early-stage biotech companies with products in development.
It's worth noting that analysts do not anticipate the company will be profitable this year, which is consistent with Unicycive's current stage of drug development and clinical trials. The negative EBITDA of -$28.84 million for the last twelve months underscores the substantial investments being made in research and development.
For investors seeking a more comprehensive analysis, InvestingPro offers additional tips and insights. There are 5 more InvestingPro Tips available for Unicycive Therapeutics, providing a deeper understanding of the company's financial health and market position.
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