molee
2 weeks ago
Unicycive Therapeutics Announces Initial Positive Patient Satisfaction Findings from Pivotal Clinical Trial of Oxylanthanum Carbonate (OLC)
– Patients preferred OLC more than 4 to 1 over their prior phosphate binder therapy –
– Median daily pill burden reduced by half after switch to OLC –
LOS ALTOS, Calif., July 10, 2024 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company” or “Unicycive”), today announced the initial results from the patient reported outcome survey conducted during the UNI-OLC-201 pivotal clinical trial. The positive top-line results from the oxylanthanum carbonate (OLC) trial in patients with hyperphosphatemia who have chronic kidney disease on dialysis were reported on June 25, 2024.
The patient reported outcomes are being evaluated from a satisfaction questionnaire that was a pre-specified exploratory objective of the study. The questionnaire surveyed patients in the UNI-OLC-201 trial to assess characteristics of their current phosphate binder as compared to OLC after switching medications. The questions included patient satisfaction, ease of use, and preferred therapy and were taken at the start and conclusion of the study. In the survey, OLC consistently outperformed the other phosphate binders in all categories: 79% of patients preferred OLC while 18% preferred their prior therapy, 98% of patients said that OLC was easy to take compared to 55% for their prior therapy, 89% of patients said they were satisfied with OLC while 49% were satisfied with their prior therapy.
“We are gratified by the encouraging patient reported findings from our pivotal trial that mirror the better-than-expected topline clinical results that we reported last month,” said, Shalabh Gupta, MD, Chief Executive Officer of Unicycive. “In the design of our pivotal clinical trial for OLC, we believed that it was important to consider the patient perspective and the personal challenges that they face in managing their hyperphosphatemia. Importantly, the results showed that patients preferred OLC greater than 4 to 1 over their prior phosphate binder therapy. Our focus is now directed toward filing our New Drug Application and making OLC available to patients who may benefit from its potential best-in-class profile, if approved.”
Pablo Pergola, MD, PhD, Research Director, Clinical Advancement Center, Renal Associates, P.A., and principal investigator for the UNI-OLC-201 trial, commented, “In this clinical study, our patients stated a clear preference for OLC over their prior phosphate lowering therapies. This positive patient reported experience with OLC is encouraging because hyperphosphatemia outcomes are often negatively impacted by non-adherence to phosphate lowering prescriptions due to side effects and high pill burden. At the end of the study, several of my patients asked not to be put back on their prior phosphate binder.”
Background
Patients screened to enter the trial were taking the following phosphate binder therapies (n=128): 52% Renvela® (sevelamer carbonate), 19% PhosLo® (calcium acetate, 15% Auryxia® (ferric citrate), 13% Velphoro® (sucroferric oxyhydroxide, and 1% Other. Once patients were enrolled into the trial, they went through a washout period for two weeks to clear their current phosphate binder from the body.
Key Findings
Preferred Therapy: In response to the question: Based on your experience in this clinical trial, do you prefer your current phosphate binder or OLC, 79% preferred OLC, 18% preferred their prior phosphate binder, and 3% preferred neither.
https://ml.globenewswire.com/Resource/Download/9a233ce4-0844-4e63-b22e-650fa9d140b6/image3.png
Ease of Use: In the trial, the median patient pill burden on OLC was reduced by half compared to their prior phosphate binder therapy. The pill burden on prior therapy at screening was a median of 6 (mean 6.5) pills per day. On OLC, the pill burden at the end of the study was a median of 3 (mean 3.9) pills per day.
In response to the question: My current phosphate binding medication is easy to take, 55% of patients agreed, 41% disagreed, and 4% neither agreed nor disagreed. In response to the question: Oxylanthanum carbonate (OLC) is easy to take, 98% of patients agreed, 1% disagreed, and 1% neither agreed nor disagreed.
https://ml.globenewswire.com/Resource/Download/39ea3031-e96f-488a-9212-331b53aa376f/image4.png
Patient Satisfaction: At screening, less than half of the patients in the study agreed with the statement, I am satisfied with my current phosphate binder medication. At the end of the study and after switching to OLC, 89% of patients agreed with the statement, I am satisfied with oxylanthanum carbonate. Only 6% expressed dissatisfaction with OLC.
https://ml.globenewswire.com/Resource/Download/1f4d052e-09f9-4043-bc89-b34cdc87ddcc/image5.png
The initial findings from the Oxylanthanum carbonate (OLC) pivotal trial satisfaction questionnaire are preliminary and subject to change based on further detailed analysis. Full survey results are expected to be presented at a future medical conference.
molee
3 weeks ago
Since you mentioned it , I checked :
"Item 5.03 Amendments to Articles of Incorporation or Bylaws; Change in Fiscal Year.
On June 20, 2024, stockholders of Unicycive Therapeutics, Inc. (the “Company”) approved an increase to the number of authorized shares of the Company’s common stock from 200,000,000 shares to 400,000,000 shares as set forth in the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on June 20, 2024. On June 21, 2024, the Company filed a Certificate of Amendment (the “Amendment”) to its Amended and Restated Certificate of Incorporation with the Delaware Secretary of State to increase its authorized shares of common stock from 200,000,000 shares to 400,000,000 shares."
https://www.otcmarkets.com/filing/html?id=17645573&guid=jXO-knJPBAGaJth
rosemountbomber
4 weeks ago
Saw this on another board so can’t vouch for accuracy but no reason to not believe:
“Maxim Group analyst Jason McCarthy maintained a Buy rating on Unicycive Therapeutics) yesterday and set a price target of $4.00.
Jason McCarthy has given his Buy rating due to a combination of factors surrounding the performance and potential of Unicycive Therapeutics’ oxylanthanum carbonate (OLC). The positive results from the UNI-OLC-201 pivotal trial, demonstrating the safety and tolerability in patients with chronic kidney disease (CKD), exceeded expectations. Despite a recent drop in UNCY shares, which McCarthy attributes to profit-taking, the impressive trial outcomes suggest a strong case for FDA approval and subsequent filing in the third quarter of 2024. These developments, along with the drug’s potential to become a leading phosphate binder, provide a solid foundation for the Buy rating. Moreover, McCarthy’s optimism is bolstered by OLC’s performance in studies, notably outperforming fosrenol with a lower discontinuation rate due to adverse events. With approximately 90% phosphate control achieved in trial participants, OLC’s efficacy is evident. Additionally, the drug’s formulation as easy-to-swallow tablets positions it competitively in the market, potentially enabling it to capture significant market share from current treatments. McCarthy’s analysis suggests that OLC’s approval could disrupt the phosphate binder landscape, which underpins the positive outlook for Unicycive Therapeutics’ stock.”
Whalatane
4 weeks ago
Well there are reasons for warrant holders to short a stock after all
Warrant holders might short a stock for several strategic reasons:
Hedging: Warrant holders may short the underlying stock to hedge their position. This strategy can protect against potential losses if the stock price declines. By shorting the stock, they can offset the loss in the value of the warrants with gains from the short position.
Arbitrage Opportunities: If the warrants are deep in the money and the stock price is expected to remain stable or decline, warrant holders might short the stock to lock in a risk-free profit. This involves shorting the stock and using the proceeds to exercise the warrants, thereby covering the short position at a lower cost.
Leverage and Gearing: Warrants provide significant leverage, meaning small changes in the stock price can lead to larger percentage changes in the value of the warrants. By shorting the stock, warrant holders can take advantage of this leverage to amplify their returns, especially if they anticipate a decline in the stock price.
Market Sentiment: If warrant holders believe the stock is overvalued or expect negative news that could drive the stock price down, they might short the stock to profit from the anticipated decline. This speculative strategy can be risky but potentially lucrative if their market predictions are accurate.
Early Exercise and Forced Sales: In some cases, such as with Special Purpose Acquisition Companies (SPACs), warrants might be called for early exercise. If warrant holders expect this and believe the stock price will drop after the warrants are exercised, they might short the stock to benefit from the expected decline.
These strategies involve significant risk and require careful consideration of market conditions and the specific terms of the warrants.
Kiwi
rosemountbomber
4 weeks ago
Kiwi, does this information help:
"Demographics and Enrollment Summary
In the study, 106 patients were enrolled, of which 86 patients entered titration and were followed as the Safety Population. Of the 86, 78 entered the maintenance period. Of the 78 patients that entered maintenance, 7 patients did not have phosphate control, leaving an Evaluable Population of 71 patients, exceeding the planned enrollment number of 60. Of the 86 patients, the trial enrolled 47 males and 39 females with a mean age of 62. Renvela® was the most prescribed phosphate binder for patients entering the study.
Primary Endpoint - Tolerability:
The objective of the OLC-201 trial was to evaluate the tolerability of clinically effective doses of OLC in CKD patients on dialysis. A clinically effective dose was established when a patient achieved a serum phosphate level ≤5.5 mg/dL. Tolerability was assessed based on the incidence of treatment-related AEs leading to discontinuation from the study in the maintenance period. In the OLC-201 trial, there was only 1 discontinuation due to a treatment-related AE in the Evaluable Population, a rate of 1.4%. In the Safety Population of 86 patients there were only 3 treatment-related discontinuations, a rate of 3.5%. In total, 5 patients discontinued due to AEs in the Safety Population, 3 were related to OLC and 2 were deemed unrelated to OLC.
Secondary Endpoint - Safety:
The secondary endpoint assessing safety was reported as the treatment-related AEs occurring in ≥5% of patients. The safety analysis covered all 86 patients in the Safety Population. Consistent with the AEs observed with other phosphate binders, the AEs were gastrointestinal related with diarrhea and vomiting being the most common at 9% and 6% respectively. There were no treatment-related serious adverse events (SAEs). Six patients experienced SAEs but those were deemed not related to OLC treatment. Most treatment-related AEs were mild to moderate in severity with only 2 AEs reported as severe.
Unicycive continues to assess the pharmacokinetics from this trial and those final data will be included in the NDA package."
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ErnieBilco
2 weeks ago
