Phase 1 single- and multiple-ascending dose study in healthy volunteers evaluating the pharmacokinetics and safety of SLTE-1009; Topline safety and pharmacokinetic data expected mid-2027
RALEIGH, N.C., Aug. 27, 2026 (GLOBE NEWSWIRE) — Slate Medicines Inc. (“Slate”), a clinical stage biotechnology company that is committed to the advancement of innovative new therapies that may broaden the treatment paradigm and potentially improve outcomes for people with migraine and other headache disorders, today announced that the first participant has been dosed in the company’s Phase 1 clinical study evaluating SLTE-1009, Slate’s subcutaneous anti pituitary adenylate cyclase-activating peptide (“PACAP”)/vasoactive intestinal peptide (“VIP”) monoclonal antibody candidate for the prevention of migraine.
The Phase 1 single- and multiple-ascending dose study is a healthy volunteer study being conducted in Australia to assess the pharmacokinetics (“PK”) and safety of SLTE-1009. Slate expects to report topline safety and PK data from the study in mid-2027.
“PACAP and VIP play a foundational role in migraine pathophysiology, and we believe SLTE-1009’s differentiated blockade of these pathways has the potential to be a best-in-class therapy for migraine prevention,” said Roger Cady, MD, Chief Medical Officer of Slate Medicines. “As a clinician who has spent my career treating migraine patients, I’ve seen firsthand how much unmet need remains. Our team is committed to advancing SLTE-1009 through clinical development and bringing meaningful change to patients living with migraine.”
“We believe dosing our first participant is a meaningful step toward our goal of advancing new preventative treatment options for patients living with migraine,” said Gregory Oakes, MBA, Chief Executive Officer of Slate Medicines. “Migraine remains a debilitating disease for millions of patients who continue to be underserved by the current standard of care, including CGRP inhibitors. We expect the data from this study to confirm SLTE-1009’s initial clinical safety profile and differentiated pharmacokinetics, which we believe can enable infrequent, subcutaneous dosing.”
About SLTE-1009
SLTE-1009 is a potential best-in-class monoclonal antibody in development for the preventative treatment of migraine. SLTE-1009 is designed to bind both PACAP and VIP, two neuropeptides with foundational roles in migraine pathophysiology, that may offer the potential for enhanced efficacy relative to PACAP-only targeting therapeutics through more complete neutralization of the PACAP/VIP pathway. SLTE-1009 was engineered with half-life extension to enable subcutaneous dosing and potential for quarterly administration.
About Slate Medicines, Inc.
Slate Medicines a clinical stage biotechnology company that is committed to the advancement of innovative new therapies that may broaden the treatment paradigm and potentially improve outcomes for people with migraine and other headache. Slate is advancing a portfolio of potentially best-in-class therapeutics, led by SLTE-1009, a clinical stage anti-PACAP/VIP monoclonal antibody designed to enable subcutaneous, infrequent dosing. For more information, please visit www.slatemedicines.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “anticipates,” “believes,” “expects,” “intends,” “projects,” “plans,” and “future” or similar expressions are intended to identify forward-looking statements. Forward-looking statements include statements concerning the potential of SLTE-1009 and Slate’s other product candidates to expand treatment options for migraine and other headache disorders and Slate’s research, development and regulatory plans for its product candidates. Forward-looking statements are based on management’s current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation, risks with respect to: the ability of Slate to retain, attract and hire key personnel; the potential failure to identify additional product candidates and develop or commercialize marketable products; the early stage of Slate’s development efforts; potential unforeseen events during clinical trials could cause delays or other adverse consequences; risks relating to the regulatory approval process; interim, topline and preliminary data may change as more patient data become available, and are subject to audit and verification procedures that could result in material changes in the final data; Slate’s product candidates may cause serious adverse side effects; inability to maintain existing or future collaborations, or the failure of these collaborations; Slate’s reliance on third parties, including for the manufacture of materials for research programs, preclinical and clinical studies; failure to obtain U.S. or international marketing approval; ongoing regulatory obligations; effects of significant competition; unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives; product liability lawsuits; securities class action litigation; the impact of general economic conditions on their respective business and operations, including Slate’s preclinical studies and clinical trials; the possibility of system failures or security breaches; and risks relating to intellectual property. These forward-looking statements speak only as of the date hereof, and Slate disclaims any obligation to update these statements except as may be required by law.
Media and Investor Contacts
ICR Healthcare
slate@icrhealthcare.com
