Bristol Myers Squibb (NYSE:BMY) today announced positive results from the Phase 3b/4 PSORIATYK SCALP trial evaluating Sotyktu (deucravacitinib) for the treatment of patients with moderate-to-severe scalp psoriasis, including those with less extensive overall psoriasis. The primary endpoint was met, with a statistically significant improvement in the scalp-specific Physician’s Global Assessment (ss-PGA) response of 0 or 1 (clear/almost clear) at 16 weeks, with more than three times as many patients achieving ss-PGA 0/1 with Sotyktu treatment compared to those on placebo (48.5% versus 13.7%, respectively; p<0.0001).

The new PSORIATYK SCALP efficacy and safety results (oral presentation FC04.07, abstract #5627), patient-reported outcomes (oral presentation FC06.06, abstract #5390) and 23 additional abstracts are being presented at the European Academy of Dermatology and Venereology (EADV) Congress in Amsterdam, Netherlands taking place September 25-28, 2024.

“Approximately 80% of people living with plaque psoriasis have scalp involvement and typically experience itching, flaking, pain and bleeding, which greatly diminish their quality of life,” said Mark Lebwohl, MD, dean of Clinical Therapeutics at the Kimberly and Eric J. Waldman Department of Dermatology at the Icahn School of Medicine at Mount Sinai and an investigator and paid consultant for Bristol Myers Squibb. “These new results reinforce that oral Sotyktu is a safe and effective once-daily treatment for people living with moderate-to-severe psoriasis, with involvement of high impact areas such as the scalp.”

The trial also met key secondary endpoints at Week 16, with a significantly higher percentage of patients achieving at least a 90% improvement in Psoriasis Scalp Severity Index (PSSI) response and a change from baseline (CFB) in scalp-specific itch with Sotyktu treatment compared with placebo (PSSI 90: 38.8% versus 2.0%, respectively, p<0.0001; mean CFB in scalp-specific itch -3.2 versus -0.7, respectively, p<0.0001). In patients with Static Physician’s Global Assessment (sPGA) ≥3, a greater proportion achieved sPGA 0/1 with Sotyktu treatment versus placebo (51.0% versus 4.3%; p<0.0001).

Greater improvements were also reported by patients receiving Sotyktu versus placebo, respectively, in achieving the minimum clinically important difference (MCID) for scalp-specific itch (41.7% versus 9.8%; p<0.0001), pain (26.2% versus 11.8%; p=0.0372) and flaking (53.4% versus 19.6%; p<0.0001), as well as whole-body itch (39.8% versus 13.7%; p=0.0009) numeric rating scale (NRS) scores.

The safety profile of Sotyktu in PSORIATYK SCALP was consistent with findings in previously conducted clinical trials of Sotyktu in psoriasis. The most common adverse events associated with Sotyktu treatment in the PSORIATYK SCALP trial were nasopharyngitis (14.6%), upper respiratory tract infection (11.7%), acne (9.7%), headache (7.8%), COVID-19 (5.8%) and pustular acne (5.8%).

Real-world analysis demonstrates consistent effectiveness with Sotyktu

An interim analysis (poster #P3311, abstract #5500) of the Registry of Psoriasis Health Outcomes: A Longitudinal Real-World Collaboration Study (RePhlect) evaluated 118 patients, 108 of whom had moderate-to-severe plaque psoriasis. This analysis found that the effectiveness after six months of continuous Sotyktu treatment in real-world registry patients was consistent with efficacy outcomes observed in the POETYK PSO clinical studies in patients living with moderate-to-severe plaque psoriasis.

Findings showed that patients in the overall group achieved statistically significant mean decreases in measures of disease severity (67.9% achieved Psoriasis Area and Severity Index (PASI) scores ≤3; PASI mean baseline score 6.3, change from baseline -4.1, p<0.001), percentage of affected Body Surface Area (BSA) scores (64.1% of patients achieved a BSA ≤3%; BSA mean baseline score 9.3, change from baseline -5.8, p<0.001) and Investigator’s Global Assessment (IGA) scores (46.8% achieved IGA scores of 0/1; IGA mean baseline score 2.7, change from baseline -1.2, p<0.001) from baseline to follow-up. Similar results were observed in the subset of patients with moderate-to-severe plaque psoriasis.

“These data further demonstrate the safety and efficacy of Sotyktu for the treatment of psoriasis in high-impact areas, such as the scalp, and include the first analysis from our RePhlect registry providing evidence highlighting the real-world benefit of Sotyktu for the treatment of moderate-to-severe plaque psoriasis,” said Daniel Quirk, MD, MPH, MBA, senior vice president, worldwide Immunology and Neuroscience medical affairs, Bristol Myers Squibb. “We believe Sotyktu has the potential to be the systemic therapy that healthcare providers turn to when treating adult patients with moderate-to-severe psoriasis, especially those with scalp involvement. Overall, these promising results reinforce once-daily Sotyktu as a potential oral standard of care as we continue to lead in TYK2 innovation.”

Sotyktu is also being studied in clinical trials across multiple immune-mediated diseases.

Bristol Myers Squibb thanks the patients and investigators involved in the ongoing PSORIATYK SCALP trial and RePhlect study.

About the PSORIATYK SCALP Trial

PSORIATYK SCALP (NCT05478499) is an ongoing, 52-week, Phase 3b/4 multicenter, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of Sotyktu in patients with moderate-to-severe scalp psoriasis, as defined by scalp-specific Physician’s Global Assessment (ss-PGA) ≥3, Psoriasis Scalp Severity Index (PSSI) ≥12 and Scalp Surface Area (SSA) ≥20%, who also had body surface area involvement ≥3%.

The Week 16 efficacy and safety analysis included 154 patients (Sotyktu, n=103; placebo, n=51).

The primary endpoint was the percentage of patients who achieved a ss-PGA score of 0 or 1 (clear/almost clear) at Week 16. Key secondary endpoints were the percentage of patients who achieved a PSSI response 90, defined as at least a 90% improvement in PSSI, change from baseline in scalp-specific itch and static Physician’s Global Assessment (sPGA) 0/1 at Week 16. Endpoints were evaluated for the overall population and the subpopulation with global sPGA score ≥3.

About the Registry of Psoriasis Health Outcomes: A Longitudinal Real-World Collaboration Study (RePhlect)

RePhlect (NCT05744466) is a prospective, observational, real-world study of adult patients with dermatologist-diagnosed psoriasis, with a targeted sample size of 2,500 Sotyktu patients in six countries (United States, Canada, United Kingdom, Germany, Japan and France). The enrollment of the study began in September 2023.

RePhlect North American cohort (United States and Canada) data are collected through the CorEvitas Psoriasis Registry, currently enrolling patients across 263 private and academic clinical sites from 596 physicians in 40 states in the United States and seven Canadian provinces.

The design and conduct of the RePhlect North American cohort study was a collaborative effort between CorEvitas and Bristol Myers Squibb, with financial support for the research provided by Bristol Myers Squibb. The CorEvitas Psoriasis Registry was developed in collaboration with the National Psoriasis Foundation.

About Psoriasis

Psoriasis is a widely prevalent, chronic, systemic immune-mediated disease that substantially impairs patients’ physical health, quality of life and work productivity. Psoriasis is a serious global problem, with at least 100 million people worldwide impacted by some form of the disease, including around 14 million people in Europe and approximately 7.5 million people in the United States. Nearly one-quarter of people with psoriasis have cases that are considered moderate-to-severe. Up to 90 percent of patients with psoriasis have psoriasis vulgaris, or plaque psoriasis, which is characterized by distinct round or oval plaques typically covered by silvery-white scales. Despite the availability of effective systemic therapy, many patients with moderate-to-severe plaque psoriasis remain undertreated or even untreated and are dissatisfied with current treatments. People with psoriasis report an impact on their emotional well-being, straining both personal and professional relationships and causing a reduced quality of life. Psoriasis is associated with multiple comorbidities that may impact patients’ well-being, including psoriatic arthritis, cardiovascular disease, metabolic syndrome, obesity, diabetes, inflammatory bowel disease and depression.

Scalp psoriasis, which occurs in approximately 80% of patients with plaque psoriasis, is associated with itching, flaking, pain and bleeding and disproportionately reduces health-related quality of life. Scalp psoriasis can be challenging to treat with topical agents and there are limited available published data about the efficacy of systemic agents in the treatment of moderate-to-severe scalp disease.

About Sotyktu (deucravacitinib)

Sotyktu (deucravacitinib) is an oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor with a unique mechanism of action, representing a new class of small molecules. It is the first selective TYK2 inhibitor in clinical studies across multiple immune-mediated diseases. Bristol Myers Squibb scientists designed Sotyktu to selectively target TYK2, thereby inhibiting signaling of interleukin (IL)-23, IL-12 and Type 1 interferons (IFN), key cytokines involved in the pathogenesis of multiple immune-mediated diseases. Sotyktu achieves a high degree of selectivity by binding to the regulatory domain of TYK2, resulting in allosteric inhibition of TYK2 and its downstream functions. Sotyktu selectively inhibits TYK2 at physiologically relevant concentrations. At therapeutic doses, Sotyktu does not inhibit JAK1, JAK2 or JAK3.

Bristol Myers Squibb: Pioneering Paths Forward in Immunology to Transform Patients’ Lives

Bristol Myers Squibb is inspired by a single vision – transforming patients’ lives through science. For people living with immune-mediated diseases, the debilitating reality of enduring chronic symptoms and disease progression can take a toll on their physical, emotional and social well-being, making simple tasks and daily life a challenge. Driven by our deep understanding of the immune system that spans over 20 years of experience, and our passion to help patients, the company continues to pursue pathbreaking science with the goal of delivering meaningful solutions that address unmet needs in rheumatology, gastroenterology, dermatology and pulmonology. We follow the science, aiming to tailor therapies to individual needs, improve outcomes and expand treatment options by working to identify mechanisms with the potential to achieve long-term remission – and perhaps even cures – in the future. By building partnerships with researchers, patients and caregivers to deliver innovative treatments, Bristol Myers Squibb strives to elevate patient care to new standards and deliver what matters most – the promise of living a better life.

SOTYKTU U.S. INDICATION

SOTYKTU^® (deucravacitinib) is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

Limitations of Use:

SOTYKTU is not recommended for use in combination with other potent immunosuppressants.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

SOTYKTU is contraindicated in patients with a history of hypersensitivity reaction to deucravacitinib or to any of the excipients in SOTYKTU.

WARNINGS AND PRECAUTIONS

Hypersensitivity: Hypersensitivity reactions such as angioedema have been reported. If a clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue SOTYKTU.

Infections: SOTYKTU may increase the risk of infections. Serious infections have been reported in patients with psoriasis who received SOTYKTU. The most common serious infections reported with SOTYKTU included pneumonia and COVID-19. Avoid use of SOTYKTU in patients with an active or serious infection. Consider the risks and benefits of treatment prior to initiating SOTYKTU in patients:

• with chronic or recurrent infection
• who have been exposed to tuberculosis
• with a history of a serious or an opportunistic infection
• with underlying conditions that may predispose them to infection.

Closely monitor patients for the development of signs and symptoms of infection during and after treatment. A patient who develops a new infection during treatment should undergo prompt and complete diagnostic testing, have appropriate antimicrobial therapy initiated and be closely monitored. Interrupt SOTYKTU if a patient develops a serious infection. Do not resume SOTYKTU until the infection resolves or is adequately treated.

Viral Reactivation

Herpes virus reactivation (e.g., herpes zoster, herpes simplex) was reported in clinical trials with SOTYKTU. Through Week 16, herpes simplex infections were reported in 17 patients (6.8 per 100 patient-years) treated with SOTYKTU, and 1 patient (0.8 per 100 patient-years) treated with placebo. Multidermatomal herpes zoster was reported in an immunocompetent patient. During PSO-1, PSO-2, and the open-label extension trial, the majority of patients who reported events of herpes zoster while receiving SOTYKTU were under 50 years of age. The impact of SOTYKTU on chronic viral hepatitis reactivation is unknown. Consider viral hepatitis screening and monitoring for reactivation in accordance with clinical guidelines before starting and during therapy with SOTYKTU. If signs of reactivation occur, consult a hepatitis specialist. SOTYKTU is not recommended for use in patients with active hepatitis B or hepatitis C.

Tuberculosis (TB): In clinical trials, of 4 patients with latent TB who were treated with SOTYKTU and received appropriate TB prophylaxis, no patients developed active TB (during the mean follow-up of 34 weeks). One patient, who did not have latent TB, developed active TB after receiving 54 weeks of SOTYKTU. Evaluate patients for latent and active TB infection prior to initiating treatment with SOTYKTU. Do not administer SOTYKTU to patients with active TB. Initiate treatment of latent TB prior to administering SOTYKTU. Consider anti-TB therapy prior to initiation of SOTYKTU in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Monitor patients for signs and symptoms of active TB during treatment.

Malignancy including Lymphomas: Malignancies, including lymphomas, were observed in clinical trials with SOTYKTU. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with SOTYKTU, particularly in patients with a known malignancy (other than a successfully treated non-melanoma skin cancer) and patients who develop a malignancy when on treatment with SOTYKTU.

Rhabdomyolysis and Elevated CPK: Treatment with SOTYKTU was associated with an increased incidence of asymptomatic creatine phosphokinase (CPK) elevation and rhabdomyolysis compared to placebo.

Discontinue SOTYKTU if markedly elevated CPK levels occur or myopathy is diagnosed or suspected. Instruct patients to promptly report unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever.

Laboratory Abnormalities: Treatment with SOTYKTU was associated with increases in triglyceride levels. Periodically evaluate serum triglycerides according to clinical guidelines during treatment. SOTYKTU treatment was associated with an increase in the incidence of liver enzyme elevation compared to placebo. Evaluate liver enzymes at baseline and thereafter in patients with known or suspected liver disease according to routine management. If treatment-related increases in liver enzymes occur and drug-induced liver injury is suspected, interrupt SOTYKTU until a diagnosis of liver injury is excluded.

Immunizations: Prior to initiating therapy with SOTYKTU, consider completion of all age-appropriate immunizations according to current immunization guidelines including prophylactic herpes zoster vaccination. Avoid use of live vaccines in patients treated with SOTYKTU. The response to live or non-live vaccines has not been evaluated.

Potential Risks Related to JAK Inhibition: It is not known whether tyrosine kinase 2 (TYK2) inhibition may be associated with the observed or potential adverse reactions of Janus Kinase (JAK) inhibition. In a large, randomized, postmarketing safety trial of a JAK inhibitor in rheumatoid arthritis (RA), patients 50 years of age and older with at least one cardiovascular risk factor, higher rates of all-cause mortality, including sudden cardiovascular death, major adverse cardiovascular events, overall thrombosis, deep venous thrombosis, pulmonary embolism, and malignancies (excluding non-melanoma skin cancer) were observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. SOTYKTU is not approved for use in RA.

ADVERSE REACTIONS

Most common adverse reactions (≥1% of patients on SOTYKTU and more frequently than with placebo) include upper respiratory infections, blood creatine phosphokinase increased, herpes simplex, mouth ulcers, folliculitis and acne.

SPECIFIC POPULATIONS

Pregnancy: Available data from case reports on SOTYKTU use during pregnancy are insufficient to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Report pregnancies to the Bristol-Myers Squibb Company’s Adverse Event reporting line at 1-800-721-5072.

Lactation: There are no data on the presence of SOTYKTU in human milk, the effects on the breastfed infant, or the effects on milk production. SOTYKTU is present in rat milk. When a drug is present in animal milk, it is likely that the drug will be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for SOTYKTU and any potential adverse effects on the breastfed infant from SOTYKTU or from the underlying maternal condition.

Hepatic Impairment: SOTYKTU is not recommended for use in patients with severe hepatic impairment.

SOTYKTU is available in 6 mg tablets.

Please see U.S. Full Prescribing Information, including Medication Guide, for SOTYKTU.

About Bristol Myers Squibb

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, that results of future post-marketing studies will be consistent with the results of these studies, that Sotyktu (deucravacitinib) for the indication described in this release may not be commercially successful, any marketing approvals, if granted, may have significant limitations on their use, and that continued approval of Sotyktu for such indication may be contingent upon verification and description of clinical benefit in additional confirmatory trials. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2023, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.

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