Actuate Therapeutics Reports Positive Phase 2 | U.S. Finance News
Actuate’s Phase 2 trial reveals elraglusib/GnP improves total survival in mPDAC sufferers, with a 37% decrease death risk.Quiver AI AbstractActuate Therapeutics introduced promising outcomes from its Phase 2 trial (Actuate-1801 Part 3B) of elraglusib mixed with gemcitabine/nab-paclitaxel (GnP) for beforehand untreated sufferers with metastatic pancreatic ductal adenocarcinoma (mPDAC) on the ASCO Annual Meeting. The trial achieved its major endpoint, exhibiting a median total survival of 10.1 months in comparison with 7.2 months for GnP alone, demonstrating a 37% discount within the risk of death. Notably, the one-year survival price doubled for sufferers receiving the mix remedy. The company plans to have interaction with the FDA by the tip of 2025 to debate product registration and can host a KOL occasion to additional focus on the trial findings. Additionally, the protection profile of elraglusib was deemed favorable, with primarily Grade 1-2 treatment-related hostile occasions reported. The examine reinforces the potential of elraglusib as a transformative remedy for mPDAC sufferers.
Potential Positives
Potential Negatives
FAQWhat had been the outcomes of the Actuate-1801 Part 3B trial?The trial confirmed a median total survival increase to 10.1 months from 7.2 months for sufferers receiving elraglusib and GnP.How did elraglusib impression survival charges in mPDAC sufferers?Patients receiving elraglusib with GnP had a 37% decreased risk of death and a 12-month survival price of 44.1%.When will Actuate Therapeutics have interaction with the FDA?The company plans to have interaction with the FDA within the second half of 2025 for product registration alignment.What security profile did elraglusib exhibit within the trial?The elraglusib/GnP mixture confirmed a manageable security profile, with treatment-emergent hostile occasions just like the GnP arm.Where can I discover more details about the trial?Additional data may be discovered on Actuate Therapeutics’ web site and during their KOL occasion held on May 31, 2025.
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CHICAGO and FORT WORTH, Texas, May 31, 2025 (GLOBE NEWSWIRE) — Actuate Therapeutics, Inc. (NASDAQ: ACTU) (“Actuate” or the “Company”), a clinical-stage biopharmaceutical company centered on developing therapies for the remedy of high-impact, difficult-to-treat cancers via the inhibition of glycogen synthase kinase-3 beta (GSK-3β), right now introduced topline outcomes from the Phase 2 (Actuate-1801 Part 3B) trial of elraglusib together with gemcitabine/nab-paclitaxel (GnP) in beforehand untreated sufferers with metastatic pancreatic ductal adenocarcinoma (mPDAC) on the American Society of Clinical Oncology (ASCO) Annual Meeting.
Abstract Title:
Preliminary outcomes from the randomized part 2 examine (1801 Part 3B) of elraglusib together with gemcitabine/nab-paclitaxel (GnP) versus GnP alone in sufferers with beforehand untreated metastatic pancreatic ductal adenocarcinoma (mPDAC).
Abstract Number
: 4006
Session Title
: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary
Presenter:
Devalingam Mahalingam, MD, PhD
Oral Presentation Date and Time
: Saturday, May 31, 2025, 4:48 PM CDT
The trial met its major endpoint of improved median total survival. Median total survival (mOS) elevated by virtually three months (10.1 months vs 7.2 months, HR=0.63, log-rank p=0.01) with a 37% discount within the risk of death and robust statistical significance, representing a clinically significant advance within the potential remedy of mPDAC. Patients receiving elraglusib with GnP achieved a 12-month survival price in 44.1% of sufferers handled—double that of GnP alone (22.3%).
Dr. Deva Mahalingam, MD, PhD, Northwestern University Feinberg School of Medicine, and lead principal investigator of the 1801 Part 3B trial commented, (*2*)
Daniel Schmitt, President & Chief Executive Officer of Actuate added, “We significantly improved mOS, cut the risk of death by 37%, and doubled the 12-month survival rate. Combined with a manageable safety profile and strong emerging mechanistic insights, these results reinforce the transformative potential of our GSK-3β inhibitor program. Based on the clear clinical benefit and well-tolerated safety profile, we intend to engage with the FDA and EMA in the second half of this year to align on a path to registration. We believe this enables us to move rapidly towards commercialization and delivery of this first-in-class therapy to patients with an urgent unmet need.”
Efficacy
Figure 1:
Actuate-1801 Part 3B: Kaplan-Meier Estimate for mOS as of March 27, 2025 (Topline information cut-off).
Safety and Biomarker Findings
KOL Event
Actuate will host a KOL occasion for the investment neighborhood right now, May 31, 2025, at 6:30 PM CDT to review the info. The webinar will function a fireplace dialogue moderated by Daniel Schmitt, President & Chief Executive Officer of Actuate, and can embody 4 distinguished KOLs: Tanios Bekaii-Saab, MD, FACP, Mayo Clinic College of Medicine and Science; Devalingam Mahalingam, MD, Northwestern University Feinberg School of Medicine; Rachna Shroff, MD, MS, FASCO, University of Arizona Cancer Center; and Colin Weekes, MD, PhD, Massachusetts General Hospital.
Event Details:
Date and Time:
Saturday, May 31, 2025, at 6:30 pm CDT
Format:
In-person and by way of dwell webcast
Registration:
Click right here
A replay of the occasion can be accessible on the Investor Relations part of the Actuate web site.
About Actuate-1801 Part 3B Study
The Actuate-1801 Part 3B examine (
NCT03678883
) is a randomized, managed Phase 2 trial of elraglusib with GnP versus GnP alone in first-line mPDAC. The trial enrolled 286 mPDAC sufferers with no prior systemic remedy for metastatic illness, who had been randomized 2:1 to the elraglusib remedy arm (elraglusib + GnP) or the control arm (GnP alone). Elraglusib is run at a dose of 9.3 mg/kg by IV infusion on Day 1 of every week of a 28-day cycle. The major endpoint for this examine is median total survival, with OS summarized all through the examine by estimates of 1-year survival. Secondary endpoints are DCR, ORR, PFS, and AE.Inhibition of GSK-3β might inhibit tumor growth and improve survival via a number of complimentary mechanisms that embody enhancement of chemotherapy exercise, activation of innate anti-tumor immunity, and regulation of gene expression, resulting in alterations in tumor metabolism and Epithelial-to-Mesenchymal Transition (EMT).
About Actuate Therapeutics, Inc.
Actuate is a clinical-stage biopharmaceutical company centered on developing therapies for the remedy of high-impact, difficult-to-treat cancers. Actuate’s lead investigational drug, elraglusib (a novel GSK-3β inhibitor), targets molecular pathways in most cancers which are concerned in selling tumor growth and resistance to standard most cancers medication akin to chemotherapy via the inhibition of nuclear issue kappa-light-chain-enhancer of activated B cells (NF-kB) and DNA Damage Response (DDR). Elraglusib may additionally mediate anti-tumor immunity via the regulation of a number of immune checkpoints and immune cell operate. For further data, please go to the Company’s web site at
http://www.actuatetherapeutics.com
.
Forward-Looking Statements
This press release comprises forward-looking statements about us, together with our and different events’ scientific trials and development plans, and our industry. The phrases “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would,” or the detrimental of these phrases or different comparable terminology are supposed to establish forward-looking statements, though not all forward-looking statements comprise these figuring out phrases. All statements, different than statements associated to current info or present circumstances or of historic info, contained on this press release are forward-looking statements. Accordingly, these statements contain estimates, assumptions, substantial dangers and uncertainties which might trigger precise outcomes to vary materially from these expressed in them, together with however not restricted to that preliminary and unpublished information could also be subject to change and additional interpretation following the provision of more information or following a more complete review of the info and shouldn’t be relied upon as a closing evaluation; the risk that scientific trial information are subject to differing interpretations and assessments by regulatory authorities and within the medical neighborhood; scientific and preclinical drug development includes a prolonged and costly course of with unsure timelines and outcomes, outcomes of prior preclinical research and early scientific trials usually are not essentially predictive of future outcomes, and elraglusib might not obtain optimistic scientific outcomes or favorable preclinical outcomes, and we might not be capable to make regulatory submissions or obtain regulatory approval on a well timed foundation, if in any respect; that we might not efficiently enroll further sufferers or set up or advance plans for additional development, together with via conversations with the FDA or EMA and the requirements such our bodies might impose for such development; that elraglusib may very well be related to negative effects, hostile occasions or different properties or security dangers, which might delay or preclude regulatory approval, trigger us to droop or discontinue scientific trials or lead to different detrimental penalties; our reliance on third events to conduct our non-clinical research and our scientific trials; our reliance on third-party licensors and skill to protect and defend our mental property rights; that we face important competitors from different biotechnology and pharmaceutical firms; our capability to fund development actions, together with as a result of our financial situation raises substantial doubt as to our capability to proceed as a going concern and we require further capital to finance our operations past the second quarter of fiscal 12 months 2025, and a failure to acquire this crucial capital within the close to time period on acceptable phrases, or in any respect, might pressure us to delay, restrict, scale back or terminate our development applications, commercialization efforts or different operations. In addition, any forward-looking statements are certified of their entirety by reference to the components mentioned underneath the heading “Item 1A. Risk Factors” in our Annual Report on Form 10-Okay for the 12 months ended December 31, 2024, filed with the SEC on March 13, 2025, our Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, filed with the SEC on May 15, 2025, and different filings with the SEC. Because the risk components referred to above might trigger precise outcomes or outcomes to vary materially from these expressed in any forward-looking statements made by us or on our behalf, you shouldn’t place undue reliance on any forward-looking statements. Further, any forward-looking assertion speaks solely as of the date on which it’s made. New components emerge from time to time, and it’s not attainable for us to foretell which components will come up. In addition, we can’t assess the impression of every issue on our business or the extent to which any issue, or mixture of components, might trigger precise outcomes to vary materially from these contained in any forward-looking statements. Unless legally required, we don’t undertake any obligation to release publicly any revisions to such forward-looking statements to mirror occasions or circumstances after the date of this press release or to mirror the prevalence of unanticipated occasions.
Investor Contact
Mike MoyerManaging DirectorLifeSci Advisors, LLC
[email protected]
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