Shattuck Labs Announces Phase 2 Clinical Trial of SL-325 in Hidradenitis Suppurativa and Appointment of Shoba Ravichandran, M.D., as Senior Vice President, Clinical Development
HS becomes SL-325's second Phase 2 indication, while cash runway guidance remains unchanged into 2029.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Summary
Shattuck Labs (NASDAQ: STTK) plans to evaluate SL-325 in a Phase 2 trial for patients with moderate to severe hidradenitis suppurativa (HS). HS becomes SL-325's second Phase 2 indication, expanding development beyond inflammatory bowel disease. The company expects the RECEPTIVE-HS1 trial to begin in 2026, with an investigational new drug application submission in October 2026 and Week 16 results in the first half of 2028.
The randomized, double-blind trial will compare two SL-325 doses with placebo, with expected enrollment of approximately 150 patients. A 16-week placebo-controlled treatment period will precede an SL-325 extension through Week 52. The primary endpoint measures patients achieving at least a 50% reduction in abscesses and inflammatory nodules without increased abscess or draining tunnel counts. Shoba Ravichandran joins as clinical development head to lead the HS program. Shattuck still expects existing cash to fund operations into 2029.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Hollow bars mark forward-looking points. How the balance works
Positive
- Moderate pointSL-325 development expands beyond inflammatory bowel disease with HS as its second Phase 2 indication.
- Minor point. Forward-looking: it has not happened yet and may not happen.RECEPTIVE-HS1 is expected to begin in 2026, evaluating two SL-325 doses against placebo.
- Minor point. Forward-looking: it has not happened yet and may not happen.Investigational new drug application submission is expected in October 2026.
- Minor point. Forward-looking: it has not happened yet and may not happen.Week 16 primary and secondary endpoint data are expected in the first half of 2028.
- Minor point. Forward-looking: it has not happened yet and may not happen.Existing cash is expected to fund operations into 2029, with runway guidance unchanged.
Negative
- None.
Key Figures
- Expected trial initiation
- 2026
- RECEPTIVE-HS1 Phase 2 trial
- Expected enrollment
- Approximately 150 patients
- RECEPTIVE-HS1
- Randomization
- 1:1:1
- Low-dose SL-325, high-dose SL-325, or placebo
- Treatment and extension periods
- 16 weeks; extension through Week 52
- Placebo-controlled treatment followed by an SL-325 extension
- Primary endpoint
- HiSCR50 at Week 16; at least a 50% reduction in AN count
- No increase in abscess or draining tunnel counts relative to baseline
- Expected IND submission
- October 2026
- SL-325 in hidradenitis suppurativa
- Expected Week 16 data
- First half of 2028
- Primary and secondary endpoints
- Cash runway guidance
- Into 2029
- Guidance remains unchanged
Previous Clinical trial Reports
-
Phase 1 SL-325 results in healthy volunteers showed favorable safety and durable DR3 blockade.
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Key Terms
pharmacokinetics medical
immunogenicity medical
placebo-controlled medical
ind submission regulatory
AI-generated analysis. How Rhea-AI works. Not financial advice.
– RECEPTIVE-HS1 Phase 2 clinical trial in patients with moderate to severe hidradenitis suppurativa (HS) expected to initiate in 2026; data from the 16-week treatment period expected in the first half of 2028 –
– HS is the second Phase 2 indication for SL-325 and expands development beyond IBD –
– Announces appointment of Shoba Ravichandran, M.D., as Senior Vice President, Clinical Development; Dr. Ravichandran to lead the HS clinical development program –
– Cash runway guidance remains unchanged, with existing cash expected to fund operations into 2029 –
AUSTIN, TX and DURHAM, NC, Oct. 01, 2026 (GLOBE NEWSWIRE) -- Shattuck Labs, Inc. (Shattuck or the Company) (NASDAQ: STTK), a clinical-stage biotechnology company pioneering the development of potential first-in-class monoclonal and bispecific DR3 blocking antibodies for the treatment of patients with inflammatory and immune-mediated diseases, today announced its plans to evaluate SL-325 in a Phase 2 clinical trial in patients with moderate to severe hidradenitis suppurativa (HS).
“We are excited to see the recent clinical validation of the TL1A/DR3 axis in patients with moderate to severe HS. We expect, by targeting DR3 instead of TL1A, SL-325 may provide potentially best-in-mechanism efficacy in indications where the TL1A/DR3 axis is proven active. Only a few biologic therapies are available to patients with moderate to severe HS, and the emerging data support the potential for TL1A/DR3 blockade to provide best-in-disease efficacy,” said Taylor Schreiber, M.D., Ph.D., Chief Executive Officer of Shattuck. “We are also very pleased to welcome Dr. Shoba Ravichandran to the team as Senior Vice President, Clinical Development. Dr. Ravichandran’s deep clinical development experience, including leading Cosentyx to approval in HS, will be important in driving toward Phase 2b data for the RECEPTIVE-HS1 study in the first half of 2028.”
RECEPTIVE-HS1 Phase 2 Trial of SL-325 in Hidradenitis Suppurativa
The RECEPTIVE-HS1 study is designed as a randomized, double-blind, placebo-controlled Phase 2 clinical trial to evaluate the efficacy and safety of two dose levels of SL-325 versus placebo in patients with moderate to severe HS. The trial will include a 16-week placebo-controlled treatment period followed by an extension period with SL-325 through Week 52.
- RECEPTIVE-HS1 is expected to enroll approximately 150 patients, randomized 1:1:1 to receive low dose SL-325, high dose SL-325, or placebo.
- The trial is expected to enroll patients with moderate to severe HS who have five or more abscesses and inflammatory nodules (AN count), no more than 20 draining tunnels, and Hurley stage II or III disease.
- The primary endpoint is the proportion of patients achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) at Week 16, defined as at least a
50% reduction in AN count, with no increase in abscess or draining tunnel counts relative to baseline. - Key secondary endpoints include the proportion of patients achieving HiSCR75 at Week 16, as well as safety and tolerability.
- Patients randomized to the placebo arm for the initial 16-week treatment period may elect to receive SL-325 during the extension period.
- In addition to efficacy, the RECEPTIVE-HS1 study will further characterize the pharmacokinetics and immunogenicity of SL-325 in patients with HS.
- IND submission is expected in October 2026.
- Week 16 data for the primary and secondary endpoints are expected to be disclosed in the first half of 2028.
Appointment of Shoba Ravichandran, M.D., as Senior Vice President, Clinical Development
Dr. Shoba Ravichandran joins Shattuck Labs as Senior Vice President, Clinical Development, and brings more than 20 years of drug development experience, including five successful major U.S. and global regulatory filings. She spent over a decade at Novartis, and in her most recent role as Senior Global Program Clinical Head, led the global approval of Cosentyx in HS and Phase 3 start-up activities for remibrutinib in HS.
Dr. Ravichandran commented, “I am delighted to join the Shattuck team and lead development of SL-325 in HS, a disease with very high unmet need and one where I believe SL-325 can be a differentiated and exciting future treatment option for patients.”
About Hidradenitis Suppurativa
Hidradenitis suppurativa (HS) is a chronic inflammatory skin disease characterized by recurrent painful nodules, abscesses and draining tunnels. The pathogenesis of HS is multifactorial and involves dysregulation of both innate and adaptive immune responses, including Th1- and Th17-associated inflammatory pathways. HS is estimated to affect approximately
About SL-325
SL-325 is a potentially first-in-class Death Receptor 3 (DR3) blocking antibody designed to achieve a complete and durable blockade of the clinically validated DR3/TL1A pathway. Shattuck’s preclinical studies demonstrated high affinity binding and superior activity over TL1A antibodies, and provided a data-driven rationale for targeting the TNF receptor, DR3, versus its ligand, TL1A. SL-325 is a fully Fc-silenced, fully human immunoglobulin G monoclonal antibody. In a Phase 1 clinical trial, SL-325 demonstrated a favorable safety profile, a potentially best-in-mechanism immunogenicity profile, no evidence of residual DR3 agonism, and provided durable blockade of TL1A binding to DR3 at low doses. SL-325 is being evaluated in a Phase 2 clinical trial in patients with Crohn’s disease, with data expected in the first half of 2028.
About Shattuck Labs, Inc.
Shattuck Labs, Inc. is a clinical-stage biotechnology company pioneering the development of potentially first-in-class monoclonal and bispecific DR3 blocking antibodies for the treatment of patients with inflammatory and immune-mediated diseases. Shattuck’s expertise in protein engineering and the development of novel TNF receptor therapeutics come together in its lead program, SL-325, a potentially first-in-class DR3 antagonist antibody designed to achieve a more complete blockade of the clinically validated DR3/TL1A pathway. The Company has offices in both Austin, Texas and Durham, North Carolina. For more information, please visit: www.ShattuckLabs.com.
Forward-Looking Statements
Certain statements in this press release may constitute “forward-looking statements” within the meaning of the federal securities laws, including, but not limited to, Shattuck’s expectations regarding: plans for its preclinical studies, clinical trials and research and development programs, particularly with respect to SL-325; the anticipated timing of initiation and expected enrollment of a Phase 2 clinical trial of SL-325 in patients with Crohn’s disease; the anticipated timing of initiation and expected enrollment of a Phase 2 clinical trial of SL-325 in patients with hidradenitis suppurativa; the clinical benefit, safety and tolerability of SL-325; anticipated development of additional preclinical pipeline candidates; the anticipated timing of initiation of a Phase 1 clinical trial of SL-846; the clinical benefit, safety and tolerability of SL-846; the anticipated release of data from SL-846; the potential clinical significance of clinical and preclinical data and expectations regarding the time period over which the Company’s capital resources will be sufficient to fund its anticipated operations. Words such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “develop,” “plan,” “anticipate” or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to it on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties (including, without limitation, those set forth in Shattuck’s filings with the U.S. Securities and Exchange Commission (SEC)), many of which are beyond its control and subject to change. Actual results or outcomes, or the timing of actual results or outcomes, could be materially different. Risks and uncertainties include: global macroeconomic conditions and related volatility; expectations regarding the initiation, progress, and expected results of the Company’s preclinical studies, clinical trials and research and development programs, including the timing and costs thereof; the Company’s ability to enroll patients in its clinical trials; the unpredictable relationship between preclinical study results and clinical study results; the Company’s ability to advance product candidates into, and successfully complete, nonclinical studies and clinical trials; the timing or likelihood of regulatory filings and approvals; the implementation of the Company’s business model, strategic plans for its business and product candidates; the scope of protection the Company is able to establish and maintain for intellectual property rights covering its technology; liquidity and capital resources, including the time period over which current capital resources are expected to the fund the Company’s operations; and other risks and uncertainties identified in Shattuck’s Annual Report on Form 10-K for the year ended December 31, 2025, and subsequent filings with the SEC. Shattuck claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. The Company expressly disclaims any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law.
The Company intends to use the investor relations portion of its website as a means of disclosing material non-public information and for complying with disclosure obligations under Regulation FD.
Investor & Media Contact:
Andrew R. Neill
Chief Financial Officer
Shattuck Labs, Inc.
InvestorRelations@shattucklabs.com
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
When does Shattuck Labs expect to start the SL-325 HS trial and report results?
Shattuck expects RECEPTIVE-HS1 to begin in 2026 and disclose Week 16 primary and secondary endpoint data in the first half of 2028. Submission of the investigational new drug application is expected in October 2026.
Which patients will qualify for Shattuck Labs' RECEPTIVE-HS1 trial?
The trial is expected to enroll patients with moderate to severe HS who have five or more abscesses and inflammatory nodules, no more than 20 draining tunnels, and Hurley stage II or III disease. Approximately 150 patients are expected to be randomized 1:1:1 to low-dose SL-325, high-dose SL-325, or placebo.
What additional outcomes will Shattuck Labs measure in the SL-325 HS trial?
Secondary endpoints include the proportion of patients achieving HiSCR75 at Week 16, along with safety and tolerability. The study will also characterize pharmacokinetics, how the body processes SL-325, and immunogenicity, the immune response to the drug.
Can placebo patients receive SL-325 in Shattuck Labs' RECEPTIVE-HS1 trial?
Patients assigned to placebo during the initial 16-week treatment period may elect to receive SL-325 during the extension period. The extension continues through Week 52.