A Phase III, Randomised, Double-blind, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Immunogenicity of SB17 (Proposed Ustekinumab Biosimilar) Compared to Stelara® in Subjects With Moderate to Severe Plaque Psoriasis

This is a randomised, double-blind, multicentre clinical study to evaluate the efficacy, safety, tolerability, PK, and immunogenicity of SB17 compared to Stelara® in subjects with moderate to severe plaque psoriasis.

Start Date06 Jul 2021

Sponsor / Collaborator

Samsung Bioepis Co., Ltd.

NCT04772274 / CompletedPhase 1

A Randomised, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Ustekinumab (SB17, EU Sourced Stelara®, and US Sourced Stelara®) in Healthy Subjects

This is a randomised, double-blind, three-arm, parallel group, single-dose study to evaluate the pharmacokinetics, safety, tolerability, and immunogenicity of SB17 compared to EU sourced Stelara® and US sourced Stelara® in healthy subjects

Start Date04 Feb 2021

Sponsor / Collaborator

Samsung Bioepis Co., Ltd.

100 Clinical Results associated with Ustekinumab-ttwe

100 Translational Medicine associated with Ustekinumab-ttwe

100 Patents (Medical) associated with Ustekinumab-ttwe

Literatures (Medical) associated with Ustekinumab-ttwe

01 Sep 2024·Journal of the American Academy of Dermatology

A randomized, double-blind, phase III study assessing clinical similarity of SB17 (proposed ustekinumab biosimilar) to reference ustekinumab in subjects with moderate-to-severe plaque psoriasis

Article

Author: Girolomoni, Giampiero ; Lee, Jiyoon ; Pulka, Grazyna ; Narbutt, Joanna ; Lee, Minkyung ; Dmowska-Stecewicz, Magdalena ; Feldman, Steven R. ; Zegadlo-Mylik, Maria Agnieszka ; Klujszo, Elzbieta ; Rajzer, Lidia ; Reznichenko, Nataliya ; Rho, Young Hee ; Brzezicki, Jan ; Rekalov, Dmytro

BACKGROUNDUstekinumab (UST) is a safe and effective treatment for moderate-to-severe psoriasis.OBJECTIVESTo compare efficacy, safety, pharmacokinetics (PK), and immunogenicity of the proposed UST biosimilar SB17 with reference UST in subjects with moderate-to-severe plaque psoriasis.METHODSIn this randomized double-blind study, subjects were randomized to receive 45 mg of SB17 or UST subcutaneously at week 0, 4, and every 12 weeks. The primary endpoint was the percent change from baseline in Psoriasis Area and Severity Index at week 12 with an equivalence margin of [-15%, 15%]. Other secondary efficacy, safety, PK, and immunogenicity endpoints were measured through week 28.RESULTSTwo hundred forty-nine subjects were randomized to SB17, 254 to UST. Adjusted difference of Psoriasis Area and Severity Index change from baseline at week 12 of -0.6% (95% confidence interval; -3.780, 2.579) was within the equivalence margin. Physician's Global Assessment and Dermatology Life Quality Index were also comparable. Overall treatment-emergent adverse events were comparable (SB17: 48.2%, UST: 48.8%). The overall incidence of antidrug antibodies up to Week 28 was 13.3% with SB17 and 39.4% with UST.LIMITATIONSData were only through week 28.CONCLUSIONSB17 was clinically biosimilar to UST up to week 28.

01 May 2024·Int. Journal of Clinical Pharmacology and Therapeutics

Comparison of SB17 and reference ustekinumab in healthy adults: A randomized, double-blind, single-dose, phase I study

Article

Author: Im, Seongsik ; Jeong, Hansol ; Lee, Jiyoon ; Kang, Taeseung

OBJECTIVEThis study compared the pharmacokinetic (PK) characteristics of SB17 (Samsung Bioepis, Incheon, Republic of Korea), a proposed biosimilar of ustekinumab (UST) against reference UST (Stelara, Janssen Biotech, Horsham, PA, USA).MATERIALS AND METHODSThis double-blind, three-arm, parallel-group, single-dose study randomized 201 healthy adult subjects 1 : 1 : 1 to receive 45 mg of SB17, European Union-sourced UST (EU-UST) or United States of America-sourced UST (US-UST) via subcutaneous (SC) injection. Primary endpoints were area under the concentration-time curve from time zero to infinity (AUC_inf) and maximum serum concentration (C_max). Safety, tolerability, and immunogenicity were investigated.RESULTSAll 90% confidence intervals (CIs) for the ratios of AUC_inf and C_max between groups were within the predefined bioequivalence margin of 0.8 - 1.25. The geometric LSMeans ratios of AUC_inf and C_max were 0.99 and 0.90 for SB17/EU-UST, 1.01 and 0.94 for SB17/US-UST, and 1.02 and 1.05 for EU-UST/US-UST, respectively. The proportion of subjects with treatment-emergent adverse events (TEAEs) was comparable between SB17, EU-UST, and US-UST (68.7, 58.2, and 65.7%). No deaths, serious adverse events (SAEs), or severe TEAEs were reported. The incidence of subjects testing positive for post-dose anti-drug antibodies (ADAs) was 26.9%, 34.3%, and 34.3% in the SB17, EU-UST, and US-UST groups, respectively. Among the subjects with a positive ADA result at day 99/end of study, 53.8% (SB17 n = 5, EU-UST n = 12, and US-UST n = 11) were positive for neutralizing antibodies (NAbs).CONCLUSIONThis study demonstrated bioequivalence of SB17, EU-UST, and US-UST in terms of PK. Safety, tolerability, and immunogenicity were also comparable between all groups.

News (Medical) associated with Ustekinumab-ttwe

30 Oct 2024

·www.globenewswire.com

Sandoz reports third-quarter and nine-month 2024 sales

Ad hoc announcement pursuant to art. 53 SIX Swiss Exchange Listing Rules MEDIA RELEASE Strong third-quarter biosimilars growth of 37% in constant currencies from existing portfolio and recent launchesGenerics growth acceleration driven by EuropeThird-quarter net sales¹ of USD 2.6 billion, up 12% in constant currencies (up 11% in USD)Nine-month net sales of USD 7.6 billion, up 9% in constant currencies (up 8% in USD)Net sales growth guidance increased to high-single digit in constant currencies (from mid- to high-single digit) and core EBITDA margin² guidance of around 20% confirmed Basel, October 30, 2024 – Sandoz (SIX:SDZ/OTCQX:SDZNY), the global leader in generic and biosimilar medicines, today announced net sales for the third quarter and nine months ended September 30, 2024. For the third quarter, net sales were USD 2.6 billion, an increase of 12% in constant currencies compared to the same quarter of the prior year. For the first nine months of 2024, net sales were USD 7.6 billion, an increase of 9% in constant currencies compared to the prior year. Richard Saynor, Chief Executive Officer of Sandoz, said: “We remain focused on execution, meeting key milestones in our biosimilars business and progressing on our journey as a standalone company. In recent months, we received approval for Pyzchiva® and Enzeevu™ in the US, launched Pyzchiva® in Europe and see continued strong uptake of Hyrimoz® in the US. “Net sales growth was achieved across generics and biosimilars, with generics accelerating in the third quarter and strong double-digit biosimilars growth in both the third quarter and first nine months. Additionally, all three regions contributed to this strong performance. We expect momentum in our business to continue, driving margin expansion through favorable product mix and leveraging our cost base. We have further advanced on our path to simplifying our business, including progression on the transformation program we launched earlier this year.” THIRD-QUARTER AND NINE-MONTH SALES Net sales for the third quarter were USD 2.6 billion, up 12% in constant currencies, compared to the third quarter of 2023. Volume contributed 13 percentage points of growth. This was partially offset by price erosion of 1 percentage point. Biosimilars were the key driver of growth in the quarter, while generics experienced solid demand. Growth accelerated in both businesses. Net sales for the first nine months of 2024 were USD 7.6 billion, up 9% in constant currencies compared to prior year. Volume contributed 11 percentage points of growth. This was partially offset by price erosion of 2 percentage points. The growth was primarily driven by biosimilars, with strong demand for both the base business and new in-market organic and acquired products in the US. Net sales by business Q3 2024Q3 2023 Change % 9M 20249M 2023 Change %USD millions unless indicated otherwise USDcc* USDcc*Generics 1 8541 794 34 5 5585 512 12Biosimilars 741 543 3637 2 0841 592 3132Net sales to third parties 2 5952 337 1112 7 6427 104 89 *constant currencies Generics overviewNet sales for the third quarter were USD 1.9 billion, up 4% in constant currencies, compared to the third quarter of 2023. Net sales for the first nine months were USD 5.6 billion, up 2% in constant currencies versus prior year. Growth in the Europe region accelerated in the third quarter, mainly driven by recent launches. The momentum continued in the International region, aided by demand for the antifungal agent Mycamine® and favorable pricing dynamics, partly offset by the divestment of the Chinese business. North America declined due to timing of new launches in the US. Biosimilars overviewNet sales for the third quarter were USD 741 million, up 37% in constant currencies, compared to the third quarter of 2023. Net sales for the first nine months were USD 2.1 billion, up 32% in constant currencies versus prior year. The strong double-digit biosimilars growth reflects the uptake of Hyrimoz® (adalimumab) in the US, the acquisition of Cimerli® (ranibizumab), the continued strong demand for our first-ever biosimilar, Omnitrope® (somatropin), and the launches of Tyruko® (natalizumab) and Pyzchiva® (ustekinumab) in Europe. Net sales by region Q3 2024Q3 2023 Change % 9M 20249M 2023 Change %USD millions unless indicated otherwise USDcc USDccEurope 1 3621 204 1312 3 9963 751 76North America 598 510 1718 1 7421 514 1515International 635 623 28 1 9041 839 49Net sales to third parties 2 5952 337 1112 7 6427 104 89 Europe overviewNet sales for the third quarter were USD 1.4 billion, up 12% in constant currencies, compared to the third quarter of 2023. Net sales for the first nine months were USD 4.0 billion, up 6% in constant currencies versus prior year. Strong growth in biosimilars continues, led by demand for Omnitrope® and the contribution from the recent launches of Tyruko® and Pyzchiva®. Generics momentum accelerated in the third quarter, driven by recent launches and the lapping of the strong prior-year comparison in the first half. North America overviewNet sales for the third quarter were USD 598 million, up 18% in constant currencies, compared to the third quarter of 2023. Net sales for the first nine months were USD 1.7 billion, up 15% in constant currencies versus prior year. Growth was driven by the ongoing uptake of Hyrimoz® in the US, the acquisition of Cimerli®, share gain of Omnitrope® in the US and the launch of Wyost®/Jubbonti® in Canada. This was partly offset by a decline in generics sales due to the timing of new launches in the US. International overviewNet sales for the third quarter were USD 635 million, up 8% in constant currencies, compared to the third quarter of 2023. Net sales for the first nine months were USD 1.9 billion, up 9% in constant currencies versus prior year. This was primarily a result of strong volume growth across both generics and biosimilars, contribution from the acquisition of Mycamine® in the prior year, favorable price dynamics and recent launches, partly offset by the divestment of the Chinese business in the second quarter. GUIDANCE 2024 On the back of strong momentum in its biosimilars business and solid generics demand, the company is increasing its full-year 2024 net sales guidance to high-single digit growth in constant currencies versus prior year (from mid- to high-single digit) and is confirming its core EBITDA margin guidance of around 20%. THIRD-QUARTER STRATEGIC MILESTONES Sandoz continued to execute on its strategy and passed additional milestones in its biosimilars portfolio. On July 1, the company announced the US FDA approval of biosimilar Pyzchiva® for all indications of the reference medicine. The company intends to launch Pyzchiva® in the US among the first wave of ustekinumab biosimilars in February 2025. On July 25, Sandoz announced the launch of biosimilar Pyzchiva® across Europe to treat chronic inflammatory diseases. Pyzchiva® was the first biosimilar to launch in Europe with all reference medicine strengths, including an initiation dose for Crohn’s disease. On August 12, Sandoz received FDA approval for Enzeevu™ to treat neovascular age-related macular degeneration. This approval further enhances the company’s leading US ophthalmology portfolio and increases access for patients. Launch timing will be dependent on several factors, including the progress and outcome of pending or potential litigation or any potential settlements. KEY LINKS Webcast – Live at 9am CET Analyst call presentationAnalyst consensus DISCLAIMER This media release contains forward-looking statements, which offer no guarantee with regard to future performance. These statements are made on the basis of management’s views and assumptions regarding future events and business performance at the time the statements are made. They are subject to risks and uncertainties including, but not confined to, future global economic conditions, exchange rates, legal provisions, market conditions, activities by competitors and other factors outside of the control of Sandoz. Should one or more of these risks or uncertainties materialize or should underlying assumptions prove incorrect, actual outcomes may vary materially from those forecasted or expected. Each forward-looking statement speaks only as of the date of the particular statement, and Sandoz undertakes no obligation to publicly update or revise any forward-looking statements, except as required by law.This media release includes non-IFRS financial measures as defined by Sandoz. An explanation of non-IFRS measures can be found in the Supplementary financial information of the Half-Year Report 2024. ABOUT SANDOZ Sandoz (SIX: SDZ; OTCQX: SDZNY) is the global leader in generic and biosimilar medicines, with a growth strategy driven by its Purpose: pioneering access for patients. More than 20,000 people of 100 nationalities work together to ensure 800 million patient treatments are provided by Sandoz, generating substantial global healthcare savings and an even larger social impact. Its leading portfolio of approximately 1,500 products addresses diseases from the common cold to cancer. Headquartered in Basel, Switzerland, Sandoz traces its heritage back to 1886. Its history of breakthroughs includes Calcium Sandoz in 1929, the world’s first oral penicillin in 1951, and the world’s first biosimilar in 2006. In 2023, Sandoz recorded net sales of USD 9.6 billion. CONTACTS Global Media Relations contacts Investor Relations contactsGlobal.MediaRelations@sandoz.comInvestor.Relations@sandoz.comSteffen Kurzawa+41 79 800 8501Laurent de Weck+41 79 795 7364Joerg E. Allgaeuer+49 171 838 4838Tamara Hackl+41 79 790 5217 SUPPORTING FINANCIAL INFORMATION Quarterly net sales 2024 Q1 2024Change % Q2 2024Change % Q3 2024Change %USD millions unless indicated otherwise USDcc USDcc USDccGenerics 1 86901 1 835-11 1 85434Biosimilars 6232121 7203537 7413637Net sales to third parties 2 49256 2 55579 2 5951112 Q1 2024Change % Q2 2024Change % Q3 2024Change %USD millions unless indicated otherwise USDcc USDcc USDcc Europe 1 32642 1 30823 1 3621312North America 52466 6202223 5981718International 642412 62759 63528Net sales to third parties 2 49256 2 55579 2 5951112 2023 Q1 2023Change % Q2 2023Change % Q3 2023Change % Q4 2023Change %USD millions unless indicated otherwise USDcc* USDcc* USDcc* USDcc* Generics 1 86826 1 85046 1 79454 1 92066Biosimilars 5161117 5331314 54374 6232926Net sales to third parties 2 38449 2 38358 2 33764 2 5431110 Q1 2023Change % Q2 2023Change % Q3 2023Change % Q4 2023Change %USD millions unless indicated otherwise USDcc* USDcc* USDcc* USDcc* Europe 1 2701016 1 2771412 1 204113 1 272104North America 496-5-3 508-4-2 510-4-3 6152020International 618-14 598-38 623312 656414Net sales to third parties 2 38449 2 38358 2 33764 2 5431110 ¹ Net sales in this document refer systematically to net sales to third parties. In the first nine months of 2023, third-party sales excluded sales to our former parent. Post spin-off, sales to our former parent are reported as third-party sales.² An explanation of non-IFRS measures can be found in the Supplementary financial information of the Half-Year Report 2024 Attachment 241030_Q3 and 9M Sales 2024_ Media Release.pdf

Drug ApprovalBiosimilarAcquisition

15 Oct 2024

·www.biospace.com

Lilly’s Omvoh Beats J&J’s Stelara in Head-to-Head Phase III Crohn’s Disease Trial

iStock, JHVEPhoto At 52 weeks of follow-up, more patients on Eli Lilly’s monoclonal antibody Omvoh demonstrated histologic response, suggesting better long-term outcomes than Johnson & Johnson’s blockbuster therapy Stelara. Eli Lilly on Monday revealed long-term data from the Phase III VIVID-1 study, demonstrating that its anti-inflammatory antibody Omvoh elicited better histologic response at 1 year versus Johnson & Johnson’s Stelara in patients with Crohn’s disease. After 52 weeks of follow-up, more patients in the overall sturdy population treated with Omvoh achieved histologic response, as defined according to the European Crohn’s and Colitis Organization’s (ECCO) criteria on mucosal histopathology. Omvoh retained the advantage even when focusing on the subgroup of patients with active histologic disease at baseline and with at least one prior biologic failure. According to Lilly, these effects were “nominally statistically significant.” In terms of safety, Omvoh’s adverse events in VIVID-1 were consistent with its known pro ulcerative colitis. Most common side effects included anemia, arthralgia and upper respiratory tract infections. Serious adverse events occurred more commonly in the placebo group. Mark Genovese, senior vice president of development at Lilly Immunology, in a statement said that with these findings from VIVID-1, the company “is setting a higher bar for the evaluation of long-term treatment response in inflammatory bowel disease,” one that employs “more ambitious targets of mucosal healing.” Omvoh is a humanized IgG4 monoclonal antibody that selectively targets and inhibits the IL-23 cytokine, thereby preventing its interaction with its corresponding receptor. Through this mechanism of action, Omvoh modulates the differentiation, proliferation and survival of several T cells and innate immune cells, exerting an overall suppressive effect on mucosal inflammation. Omvoh is approved for the treatment of moderately to severely active ulcerative colitis, for which it won the FDA’s nod in October 2023 . Lilly is working toward the expansion of Omvoh’s label, using Monday’s data from VIVID-1 to support its regulatory submission with the FDA and other global health authorities. Lilly is also continuing to expand its understanding of the therapeutic potential of Omvoh in inflammatory bowel diseases, with ongoing trials in Crohn’s disease and ulcerative colitis in children. If Lilly succeeds in pushing Omvoh into Crohn’s disease, it will compete with J&J’s blockbuster drug Stelara, a deeply entrenched treatment option in the inflammatory diseases space. In 2023, Stelara sales jumped 11.7% to nearly $10.9 billion . Aside from the potential threat of Omvoh, Stelara is currently contending with mounting biosimilar competition due to the expiration of its crucial patent protections. In April 2024, Teva and Alvotech won the FDA’s approval for Selarsdi, their Stelara copycat for psoriatic arthritis and plaque psoriasis. Selarsdi, however, is not approved for Crohn’s disease and ulcerative colitis. In July 2024, Samsung Bioepis got regulatory approval for its biosimilar Pyzchiva, which will compete with Stelara in psoriatic arthritis, Crohn’s disease and ulcerative colitis.

Clinical ResultPhase 3Drug ApprovalImmunotherapyBiosimilar

11 Oct 2024

·www.pharmaceutical-technology.com

South Korean company Dong-A ST wins FDA approval for Stelara biosimilar

Stelara is indicated for use in patients with active psoriatic arthritis as well as moderate to severe Crohn’s disease, plaque psoriasis, and active ulcerative colitis. Credits: Tada Images/Shutterstock.com South Korea-based Dong-A ST has received a US Food and Drug Administration (FDA) approval for Imuldosa (ustekinumab-srlf/DMB-3115), a biosimilar that references Johnson & Johnson ’s (J&J) blockbuster therapy Stelara (ustekinumab). As per an 11 October press announcement, the company will launch Imuldosa in the US. However, it did not specify the product’s launch date. While Stelara’s composition of matter patent expired in September 2023, none of the approved biosimilars have been launched yet, and Imuldosa will face an increasingly crowded biosimilar market when it can be made available. The list of already approved biosimilars includes Amgen ’s interchangeable biosimilar Wezlana (ustekinumab-auub), which became the first approved Stelara biosimilar when it gained FDA approval in November 2023. However, Amgen’s copycat therapy will not enter the market until 1 January 2025 after settling a patent lawsuit with J&J. Similarly, Samsung Bioepis’s Pyzchiva (ustekinumab-ttwe), another interchangeable biosimilar, which gained approval in July 2024, will not gain its “interchangeable” designation until the exclusivity period for Wezlana ends, and will be launched in February 2025. Additional approved biosimilars include Alvotech and Teva Pharmaceuticals’ Selarsdi (ustekinumab-aekn) and Fresenius Kabi and Formycon’s Otulfi (ustekinumab-aauz). The latter became the fourth approved biosimilar earlier this month and is expected to launch on the market a month after Wezlana. See Also: Activist investor Starboard cries foul play in exec U-turn at Pfizer Activist investor Starboard forges $1bn stake in Pfizer to swing profits In accordance with the 2023 patent expiry, which tends to weaken sales of a brand name product, GlobalData’s consensus forecasts project a steady drop in the total sales of Stelara starting in 2024. While Stelara generated $10.9bn in sales in 2023 in a market without any biosimilars, the forecast predicts Stelara’s revenue to slip to $10bn in 2024, $7.1bn in 2025, and $5.2bn in 2026. GlobalData is the parent company of Pharmaceutical Technology. Stelara is a human IgG1 kappa monoclonal antibody designed to bind with high affinity and specificity to the IL-12 subunit beta used by the interleukin (IL)-12 and IL-23 cytokines, which are implicated to play a role in inflammation. Stelara is indicated for use in patients with active psoriatic arthritis as well as moderate to severe Crohn’s disease, plaque psoriasis, and active ulcerative colitis. Other Stelara biosimilars in development include Accord BioPharma’s DMB-3115, Celltrion ’s CT-P43, and Biocon ’s BMAB-1200. Earlier in February 2024, Rani Therapeutics announced positive topline data from its Phase I study (NCT05890118) of RT-111, a non-injectable Stelara biosimilar version that contains CT-P43.

Phase 1Drug ApprovalBreakthrough TherapyClinical Result

100 Deals associated with Ustekinumab-ttwe

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Approved

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Indication	Country/Location	Organization	Date
Arthritis, Psoriatic	LI	Samsung Bioepis Co., Ltd.	19 Apr 2024
Arthritis, Psoriatic	IS	Samsung Bioepis Co., Ltd.	19 Apr 2024
Arthritis, Psoriatic	EU	Samsung Bioepis Co., Ltd.	19 Apr 2024
Arthritis, Psoriatic	NO	Samsung Bioepis Co., Ltd.	19 Apr 2024
Crohn's disease, active moderate	LI	Samsung Bioepis Co., Ltd.	19 Apr 2024
Crohn's disease, active moderate	IS	Samsung Bioepis Co., Ltd.	19 Apr 2024
Crohn's disease, active moderate	NO	Samsung Bioepis Co., Ltd.	19 Apr 2024
Crohn's disease, active moderate	EU	Samsung Bioepis Co., Ltd.	19 Apr 2024
Plaque psoriasis	EU	Samsung Bioepis Co., Ltd.	19 Apr 2024
Plaque psoriasis	IS	Samsung Bioepis Co., Ltd.	19 Apr 2024
Plaque psoriasis	NO	Samsung Bioepis Co., Ltd.	19 Apr 2024
Plaque psoriasis	LI	Samsung Bioepis Co., Ltd.	19 Apr 2024
Ulcerative colitis, active moderate	EU	Samsung Bioepis Co., Ltd.	19 Apr 2024
Ulcerative colitis, active moderate	LI	Samsung Bioepis Co., Ltd.	19 Apr 2024
Ulcerative colitis, active moderate	IS	Samsung Bioepis Co., Ltd.	19 Apr 2024
Ulcerative colitis, active moderate	NO	Samsung Bioepis Co., Ltd.	19 Apr 2024
Ulcerative colitis, active severe	IS	Samsung Bioepis Co., Ltd.	19 Apr 2024
Ulcerative colitis, active severe	EU	Samsung Bioepis Co., Ltd.	19 Apr 2024
Colitis, Ulcerative	KR	Samsung Bioepis Co., Ltd.	11 Apr 2024
Crohn Disease	KR	Samsung Bioepis Co., Ltd.	11 Apr 2024

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Plaque psoriasis	Phase 3	KR	Samsung Bioepis Co., Ltd.	06 Jul 2021
Plaque psoriasis	Phase 3	UA	Samsung Bioepis Co., Ltd.	06 Jul 2021

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


GlobeNewswire Manual	Phase 3	Plaque psoriasis	-	SB17	(rjnhrmkpvm): Difference = -0.6 (95% CI, −3.780 - 2.579) Met	Positive	11 Oct 2023
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