Kaerus Bioscience Successfully Completes Phase 1 Trial and Demonstrates Proof of Mechanism with its Novel BK Channel Modulator KER-0193 being developed for Fragile X Syndrome
In the trial, KER-0193 was found to be safe and well-tolerated in both single ascending dose and multiple ascending dose cohorts involving 56 healthy volunteers. The drug also exhibited an excellent, dose-proportional pharmacokinetic profile across a wide range of doses.
A planned biomarker substudy profiling brain activity using electroencephalography (EEG) was also completed as part of the Phase 1 clinical trial. The results of this pharmaco-EEG study revealed significant pharmacodynamic effects of KER-0193 on multiple, translationally-relevant parameters of brain activity, providing clear clinical evidence of central target engagement for KER-0193.
Pharmaco-EEG also revealed a unique topography of KER-0193 effects on brain excitability that specifically maps to cortical regions commonly reported as abnormal by EEG in patients with FXS. This pattern of regional effects on brain excitability replicates observations from EEG profiling of KER-0193 in preclinical animal studies, demonstrating proof of mechanism.
'These results are a significant milestone for Kaerus,' said Dr. Robert Ring, CEO, Kaerus Bioscience. 'The data clearly demonstrate our first-in-class BK channel modulator is active in the CNS, and is both safe and well-tolerated. Taken together with the positive 'proof of mechanism' with EEG, we feel extremely excited and confident heading into Phase 2 in the target population.'
The company is currently finalizing preparations for a Phase 2 proof of concept study in FXS patients.
About Kaerus BioscienceKaerus Bioscience Ltd is a clinical-stage biotechnology company committed to turning scientific advances into treatment realities for patients with rare genetic syndromes of neurodevelopment. Kaerus has developed a pipeline of targeted, small-molecule therapeutics that address an underlying ion channel dysfunction in Fragile X syndrome, the most common inherited cause of intellectual disability and autism globally.
About KER-0193KER-0193 is a novel, proprietary, and orally-bioavailable small molecule modulator of BK channels discovered by Kaerus. KER-0193 specifically addresses abnormal function of BK channels linked to the genetic cause of Fragile X syndrome. KER-0193 has already demonstrated broad effects on improving syndrome-relevant behavioral, sensory and cognitive deficits observed in genetic animal models of Fragile X. Fragile X syndrome is the most common inherited cause of autism and intellectual disability globally. There are currently no approved treatments for Fragile X.
About MedicxiMedicxi is a healthcare-focused investment firm with the mission to create and invest in companies across the full drug development continuum. Leveraging deep expertise in drug development and company creation spanning over two decades, Medicxi invests in early and late-stage therapeutics with a product vision that can fulfil a clear unmet medical need. For more information, please visit: https://www.medicxi.com
ContactFor more information, please visit www.kaerusbio.com or contact info@kaerusbio.com
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Business Upturn
4 hours ago
- Business Upturn
AAPL LOSS ALERT: Apple Inc. Investors with Losses are Reminded of the August 19 Class Action Deadline – Contact BFA Law (NASDAQ:AAPL)
NEW YORK, Aug. 17, 2025 (GLOBE NEWSWIRE) — Leading securities law firm Bleichmar Fonti & Auld LLP announces that a lawsuit has been filed against Apple Inc. (NASDAQ: AAPL) and certain of the Company's senior executives for potential violations of the federal securities laws. If you invested in Apple, you are encouraged to obtain additional information by visiting: Investors have until August 19, 2025, to ask the Court to be appointed to lead the case. The complaint asserts claims under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 on behalf of investors who purchased Apple securities. The case is pending in the U.S. District Court for the Northern District of California and is captioned Tucker v. Apple Inc., et al. , No. 5:25-cv-05197. Why was Apple Sued for Securities Fraud? Apple is a multinational technology company that engages primarily in the businesses of smart-devices and artificial intelligence ('AI'). Apple's software includes a digital personal assistant called 'Siri,' which was first introduced in October 2011. The complaint alleges that Apple misrepresented Siri's advanced AI-based features as well as its ability to deliver them within the iPhone 16 product cycle. In truth, as alleged, Apple lacked a functional prototype of Siri's purported advanced AI-based features and misrepresented the time it would take to integrate such features into its devices. The Stock Declines as the Truth is Revealed On March 7, 2025, Apple announced it was indefinitely delaying several AI-based Siri features, citing development delays and pushing their release to sometime 'in the coming year.' On this news, the price of Apple stock declined $11.59 per share, or almost 5%, from $239.07 per share on March 7, 2025, to $227.48 per share on March 10, 2025, the following trading day. Then, on June 9, 2025, Apple hosted its Worldwide Developer Conference for 2025. Noticeably, Apple failed to announce any new updates regarding advanced Siri features. Analysts and media outlets described the WWDC as 'underwhelming' and 'disappointing,' with CNN stating that 'it's unlikely that any of the announcements made at Monday's event will change the perception that Apple is behind its competitors in AI.' On this news, the price of Apple stock declined $2.47 per share, or over 1%, from $203.92 on June 6, 2025, to $201.45 per share on June 9, 2025, the following trading day. Click here for more information: What Can You Do? If you invested in Apple you may have legal options and are encouraged to submit your information to the firm. All representation is on a contingency fee basis, there is no cost to you. Shareholders are not responsible for any court costs or expenses of litigation. The firm will seek court approval for any potential fees and expenses. Submit your information by visiting: Or contact:Ross Shikowitz [email protected] 212.789.3619
Business Upturn
4 hours ago
- Business Upturn
LINE LOSS ALERT: Lineage, Inc. Investors with Losses are Reminded of the September 30 Class Action Deadline – Contact BFA Law (NASDAQ:LINE)
NEW YORK, Aug. 17, 2025 (GLOBE NEWSWIRE) — Leading securities law firm Bleichmar Fonti & Auld LLP announces that a lawsuit has been filed against Lineage, Inc. (NASDAQ: LINE) and certain of the Company's senior executives and directors for potential violations of the federal securities laws. If you invested in Lineage, you are encouraged to obtain additional information by visiting: Investors have until September 30, 2025, to ask the Court to be appointed to lead the case. The complaint asserts claims under Sections 11 and 15 of the Securities Act of 1933 on behalf of investors who purchased stock pursuant and/or traceable to Lineage's registration statement for its initial public offering held on or about July 25, 2024. The case is pending in the U.S. District Court for the Eastern District of Michigan and is captioned City of St. Clair Shores Police and Fire Retirement System v. Lineage, Inc., et al. , No. 2:25-cv-12383. Why Was Lineage Sued Under the Federal Securities Laws? Lineage is a cold storage focused real estate investment trust ('REIT'). Through its Global Warehousing Segment, Lineage owns and operates hundreds of temperature-controlled storage facilities used by companies to store food and other perishable products. As alleged, Lineage's IPO documents touted its 'consistent cold chain demand,' which purportedly provided Lineage 'with strong cash flows even during periods of broader economic stress.' The IPO documents also represented that the lingering effects of the COVID-19 pandemic had 'accelerated trends that . . . have the potential to be growth engines for the industry in coming years.' In truth, Lineage was allegedly in the midst of a sustained downturn, as its customers destocked excess inventory built up during the COVID-19 pandemic, and also shifted to leaner inventories on a go-forward basis and as more cold-storage supply came on line. Events Following the IPO On February 26, 2025, Lineage announced its fiscal Q4 2024 financial results, revealing that customers had been 'unwinding' previously 'overbuil[t]' levels of inventory, returning to a 'more normal seasonal pattern' that was expected to 'continue moving forward.' Lineage conducted its IPO at $78 per share. Since the IPO, the price of Lineage stock has fallen dramatically, to lows near $40 per share—approximately half the IPO price. Click here for more information: What Can You Do? If you invested in Lineage you may have legal options and are encouraged to submit your information to the firm. All representation is on a contingency fee basis, there is no cost to you. Shareholders are not responsible for any court costs or expenses of litigation. The firm will seek court approval for any potential fees and expenses. Submit your information by visiting: Or contact:Ross Shikowitz [email protected] 212.789.3619
Business Upturn
4 hours ago
- Business Upturn
CNC LOSS ALERT: Centene Corporation Investors with Losses are Reminded of the September 8 Class Action Deadline – Contact BFA Law (NYSE:CNC)
NEW YORK, Aug. 17, 2025 (GLOBE NEWSWIRE) — Leading securities law firm Bleichmar Fonti & Auld LLP announces that a lawsuit has been filed against Centene Corporation (NYSE: CNC) and certain of the Company's senior executives for potential violations of the federal securities laws. If you invested in Centene, you are encouraged to obtain additional information by visiting: Investors have until September 8, 2025, to ask the Court to be appointed to lead the case. The complaint asserts claims under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 on behalf of investors who purchased Centene securities. The case is pending in the U.S. District Court for the Southern District of New York and is captioned: Lunstrum v. Centene Corporation, et al. , No. 25-cv-05659. Why was Centene Sued for Securities Fraud? Centene is a healthcare company that focuses on providing services to consumers enrolled in government-sponsored healthcare programs like Medicaid and Medicare, as well as those that purchase insurance under the Affordable Care Act from the Health Insurance Marketplace. On December 12, 2024, Centene announced financial guidance for fiscal year 2025 which the company said reflected '[s]tability in earnings power in the face of unprecedented headwinds.' Next, on February 4, 2025, Centene increased its 2025 guidance due to enrollment 'overperformance.' Then, on April 25, 2025, Centene again increased 2025 guidance due to continued strong growth in enrollment and retention, while touting the 'progress we are making as an organization while navigating a dynamic policy landscape.' In truth, the majority of the market that Centene serves was experiencing lower than expected enrollment growth and increased morbidity rates, or frequency of disease and illness. The Stock Declines as the Truth is Revealed On July 1, 2025, Centene abruptly withdrew its previous guidance after reviewing an independent actuarial report from Wakely Consulting Group which showed that overall market growth in 22 of the 29 states Centene serves was lower than expected and that morbidity in those states was significantly higher than expected. On this news, the price of Centene stock fell $22.87 per share, or more than 40%, from $56.65 per share on July 1, 2025 to $33.78 per share on July 2, 2025. Click here for more information: What Can You Do? If you invested in Centene you may have legal options and are encouraged to submit your information to the firm. All representation is on a contingency fee basis, there is no cost to you. Shareholders are not responsible for any court costs or expenses of litigation. The firm will seek court approval for any potential fees and expenses. Submit your information by visiting: Or contact:Ross Shikowitz [email protected] 212.789.3619
