Quince Therapeutics' Clinical Trial Fails to Meet Primary Endpoint
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 15h ago
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Source: Newsfilter
- Clinical Trial Results: Quince Therapeutics' NEAT trial failed to achieve statistical significance on its primary endpoint, with mean changes from baseline to six months of 0.94 in the active arm versus 2.24 in the placebo arm, resulting in a difference of -1.30 and a p-value of 0.0851, indicating limited treatment efficacy.
- Key Secondary Endpoint Failure: The trial also did not meet its key secondary endpoint for Clinical Global Impression of Severity (CGI-S), with a p-value of 0.522, further demonstrating that eDSP did not meet efficacy expectations.
- Development Plan Halted: In light of the disappointing results, the company has decided to cease clinical development of eDSP, aiming to preserve cash and explore available options, which may impact future R&D investments and market strategy.
- Patient Population Context: Ataxia-Telangiectasia (A-T) is a rare genetic neurodegenerative disorder, with approximately 4,600 diagnosed patients in the U.S.; the failure of Quince's eDSP treatment underscores the unmet therapeutic needs and market opportunities in this area.
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Analyst Views on QNCX
Wall Street analysts forecast QNCX stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for QNCX is 7.00 USD with a low forecast of 5.00 USD and a high forecast of 10.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
3 Analyst Rating
3 Buy
0 Hold
0 Sell
Strong Buy
Current: 3.180
Low
5.00
Averages
7.00
High
10.00
Current: 3.180
Low
5.00
Averages
7.00
High
10.00
About QNCX
Quince Therapeutics, Inc. is a late-stage biotechnology company. The Company is engaged in unlocking the patient’s own biology to deliver life-changing therapeutics to those living with rare diseases. Its proprietary autologous intracellular drug encapsulation (AIDE) technology platform is a drug/device combination that uses an automated process designed to encapsulate a drug into the patient’s own red blood cells. The Company’s Phase III lead asset, eDSP, leverages its AIDE technology to encapsulate dexamethasone sodium phosphate (DSP) into a patient’s own red blood cells, and is targeted to treat a rare pediatric neurodegenerative disease, Ataxia-Telangiectasia (A-T). Its AIDE technology is designed to allow for the chronic administration of drugs that have limitations due to toxicity, poor biodistribution, suboptimal pharmacokinetics, or immune response. The AIDE technology platform delivers a variety of therapeutics, ranging from small to large molecules drugs and biologics.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Quince's Clinical Trial Fails to Meet Key Endpoints
- Trial Results Disappoint: Quince's late-stage trial involving 105 patients with Ataxia-Telangiectasia failed to meet its primary endpoint, indicating a lack of statistical significance in treatment efficacy, prompting the company to cease clinical development of its lead asset.
- Stock Price Plummets: Following the announcement of the trial failure, shares of Quince Therapeutics, Inc. (QNCX) closed down 92% on Thursday, reflecting extreme investor pessimism regarding the company's future prospects.
- Market Reaction: Despite the significant drop in stock price, QNCX shares saw a slight 2% increase in after-hours trading, indicating some investor optimism, particularly as retail sentiment on Stocktwits shifted from 'neutral' to 'bullish' over the past 24 hours.
- Industry Context: Ataxia-Telangiectasia is a rare inherited neurodegenerative disorder with no approved therapies globally, despite approximately 4,600 diagnosed patients in the U.S., highlighting a significant unmet medical need in this area.
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Quince Therapeutics Reports Phase 3 Trial Results for A-T Treatment
- Trial Results: Quince Therapeutics announced topline results from its pivotal Phase 3 NEAT trial for Ataxia-Telangiectasia (A-T), where the active group showed a mean change of 0.94 compared to 2.24 in the placebo group among 105 participants, failing to achieve statistical significance (p=0.0851), indicating limited treatment efficacy.
- Safety Profile: While eDSP was generally well tolerated during the trial, common adverse events included pruritus and pyrexia, with no clinically meaningful safety concerns identified, providing a foundation for future therapeutic options.
- Patient Transition to OLE: Nearly all participants (except one) opted to transition to the company's open-label extension study after completing the treatment period, reflecting sustained interest and potential long-term efficacy expectations from patients.
- Market Potential: With approximately 4,600 diagnosed A-T patients in the U.S. and an estimated 5,000 in the U.K. and EU4 countries, the current lack of approved treatments highlights the potential demand for eDSP in the future market.
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