pegcantratinib (SNA-120) / Sienna - LARVOL DELTA

Mortality and Neurological Complications Associated with Rapid vs. Slow Correction of Moderate Hyponatremia (KIDNEY WEEK 2025) - "Information is lacking for moderate hyponatremia (SNa 120 - 130 mEq/L)...ODS was present in 6 pts, (0.05%) with a similar incidence between rapid and slow correction (2/1,695 vs. 4/10,384, p = 0.20; Fisher’s exact test). Conclusion Rapid correction (≥8 mEq/L/24hr) of moderate hyponatremia is associated with decreased adjusted in-hospital mortality without an increased incidence of ODS."

Alzheimer's Disease • Cardiovascular • Chronic Obstructive Pulmonary Disease • CNS Disorders • Dementia • Fibrosis • Heart Failure • Hepatology • Immunology • Respiratory Diseases

Latent Profile Analysis for Patient Activation in Patients with Essential Hypertension. (PubMed, Patient Prefer Adherence) - "A convenience sampling method was employed to select 301 patients with essential hypertension from an outpatient clinic in a tertiary care hospital located in Shanghai for a cross-sectional study...Increased income, health literacy and self-efficacy facilitate activation. Interventions must improve self-efficacy and refine health education to enhance patient engagement and self-management."

Journal • Cardiovascular • Hypertension

Lymphoproliferative Disorder Of The Vulva - A Rare Case Report (ESGO 2025) - "The patient underwent R-COP chemotherapy (rituximab 600mg i.v. day 1, Fosaprepitant 150 mg i.v. day 2, Mesna 1200 mg i.v. day 2, Vincristine 2mg and Cyclophosphamide 1200 mg from day 2 to day 6 every 14 days for 4 cycles) without consolidation radiotherapy considering the fast achievement of complete response after 2 cycles of treatment. Our patient achieved complete remission after 2 cycles of R-COP regimen. Conclusion Primary non-Hodgkin's malignant lymphoma of the vulva remains undiagnosed due to its uncommon presentation; thus gynecologic oncologists, and onco-pathologists should be aware of this clinical entity."

Case report • Clinical • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Gynecologic Cancers • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

The E3 ligase OsPUB33 controls rice grain size and weight by regulating the OsNAC120-BG1 module. (PubMed, Plant Cell) - "Additionally, OsNAC120 transcriptionally activates BIG GRAIN1 (BG1), a prominent modulator of grain size, whereas OsPUB33 impairs the OsNAC120-mediated regulation of BG1. Collectively, our findings uncover an important molecular framework for the control of grain size and weight by the OsPUB33-OsNAC120-BG1 regulatory module and provide promising targets for improving crop yield."

Journal • Targeted Protein Degradation

OsNAC120 balances plant growth and drought tolerance by integrating the GA and ABA signaling in rice. (PubMed, Plant Commun) - "Together, our findings provide the evidence that OsNAC120 plays critical roles in balancing GA-mediated growth and ABA-induced drought tolerance in rice. The research will help us understand the mechanisms underlying the "trade-off" between plant growth and stress tolerance, and engineer stress-resistant and high-yielding crops."

Journal

Laccase-Based Self-Amplifying Catalytic System Enables Efficient Antibiotic Degradation for Sustainable Environmental Remediation. (PubMed, Adv Sci (Weinh)) - "In SACS, a natural mediator-regenerating koji with high-activity LAC, derived from lignocellulosic waste, initiates the chlortetracycline (CTC) degradation. Subsequently, an intermediate product, CTC327, identified as an active mediator for LAC via molecular docking, is formed and then starts a renewable reaction cycle, including CTC327-LAC interaction, stimulated CTC bioconversion, and self-amplifying CTC327 release, thus enabling highly efficient antibiotic bioremediation...The resulting CTC degradation rate is 93.43%, with a straw mass loss of up to 58.35% in a coupled process. This mediator regeneration and waste-to-resource conversion in SACS provides a promising route for environmental remediation and sustainable agricultural practices."

Journal

[VIRTUAL] Hyponatremia Is Common After Indwelling Catheter Drainage of Malignant Ascites (KIDNEY WEEK 2020) - " The overall incidence of hyponatremia post-IPC placement was 85%, of whom 8% had severe hyponatremia with a serum sodium (sNa) sNa<120 mEq/L... Though IPC placement is often a palliative measure, hyponatremia is common, and severe hyponatremia may be associated with shorter survival. These patients may warrant closer monitoring post-catheter placement. Funding: Other NIH Support"

Biliary Cancer • Cardiovascular • Heart Failure • Oncology • Pancreatic Cancer

Creabilis Announces Positive Phase IIa Results for TrkA Kinase Inhibitor CT327 in Psoriasis Vulgaris (Creabilis) -

P2, N=48; In the PGA analysis, 33% of pts had “controlled disease” at the end of the 8 weeks treatment period compared to 8% at the start of the study & the number of ‘severe or very severe’ pts was reduced by 50% over the same period

Psoriasis

Tropomyosin Receptor Antagonism in Cylindromatosis (TRAC), an early phase trial of a topical tropomyosin kinase inhibitor as a treatment for inherited CYLD defective skin tumours: study protocol for a randomised controlled trial. (PubMed) - Trials - "Interventions for rare genetic skin diseases are often difficult to assess in an unbiased way due to small patient numbers and the challenges of incorporating adequate controls into trial design. Here we present a single-centre, randomised, placebo-controlled trial design that leverages the multiplicity of tumours seen in an inherited skin tumour syndrome that may inform the design of other studies in similar genetic diseases."

Journal • Biosimilar • Pain

Creabilis to present CT327 phase 2b data at American Academy of Dermatology (AAD) annual meeting (Creabilis Press Release) - P2b, N=160; Sponsor:Creabilis; NCT01465282; "The reduction from baseline in pruritus VAS reached 60% for patients treated with CT327 compared to 20% for patient treated with vehicle (p<0.05). Up to 62% of patients treated with CT327 achieved at least a 50% reduction in pruritus VAS compared to 32% of patients on vehicle (p<0.05). At baseline, 69% of patients reported at least moderate pruritus (VAS > 40mm). CT327 was safe and well tolerated, with no application site reactions."; Anticipated topline P2b data for Pruritus in mid-2014.

Anticipated P2b data • Conference • P2b data • Psoriasis

Topical TrkA Kinase Inhibitor CT327 is an Effective, Novel Therapy for the Treatment of Pruritus due to Psoriasis: Results from in vitro and Tissue Experimental Studies, and Efficacy and Safety of CT327 in a Phase 2b, Randomised, Double-blind, Vehicle-... (PubMed) - "CT327 inhibited capsaicin responses, indicating action at the nerve growth factor-TrkA-TRPV1 pathway. TrkA is a key target in pruritus, and CT327 has potential to become an effective and safe first-in-class treatment."

Journal • Biosimilar • Growth Hormone • Immunology • Inflammation • Psoriasis

Sienna Biopharmaceuticals announces its topical, non-steroidal TrkA inhibitor SNA-120 (0.05%) demonstrated significant impact on psoriasis in phase 2b study and plans to initiate phase 3 psoriasis trials in second half of 2019 (GlobeNewswire) - P2b, N=208; NCT03322137; Sponsor: Sienna Biopharmaceuticals; "Sienna Biopharmaceuticals...today announced top-line results from a Phase 2b study of SNA-120 (pegcantratinib)...in mild-to-moderate psoriasis patients with at least moderate pruritus (itch)...Patients treated with SNA-120 (0.05%) experienced a mean 4.3 point (58%) reduction from baseline on the I-NRS, compared to a mean 4.0 point (55%) reduction with vehicle (not statistically significant, p=0.244).  SNA-120 (0.5%) showed similar results....We expect to start our Phase 3 studies for psoriasis in the second half of 2019."

New P3 trial • P2b data • Immunology • Inflammation • Psoriasis

Creabilis: Biotech & Money (Creabilis) - Anticipated NDA filing for pruritic psoriasis in 2017

Anticipated NDA • Psoriasis

Sienna Biopharmaceuticals announces first patient dosed in phase 2b trial of topical SNA-120 (GlobeNewswire) - P2b, N=190; "Sienna Biopharmaceuticals today announced that the first patient has been dosed in the Company’s Phase 2b clinical trial of topical product candidate SNA-120 (pegcantratinib) in the treatment of pruritus, or itch, associated with psoriasis and in the treatment of psoriasis itself...'We look forward to the data, which we expect to report in the first half of 2019.'"

Enrollment open • P2b data • Immunology • Psoriasis

Sienna Biopharmaceuticals to cease operations (San Fernando Valley Business Journal) - "Sienna Biopharmaceuticals Inc. will cease operations by the end of the week...according to a filing Wednesday with the Securities and Exchange Commission....There were no bids for Sienna’s other drugs, including flagship topicals SNA-120 for psoriasis and SNA-125 for atopic dermatitis."

Commercial

SNA-120, a novel topical non-steroidal therapy for psoriasis and associated pruritus that targets the NGF/TrkA pathway: Results from a multicenter phase 2bstudy (IFSI 2019) - P2b, N=208; "Adults treated with SNA-120 (0.05%) achieved statistically significant and clinically meaningful improvements on prespecified psoriasis regulatory endpoints. Itch was substantially reduced from baseline in both groups; however, the primary endpoint was not met. Targeting the NGF/TrkA pathway with SNA120 may represent a novel topical non-steroidal treatment option for the majority of patients with psoriasis."

P2b data

Sienna Biopharmaceuticals files for bankruptcy, delaying phase III psoriasis trial (BioSpace) - "Southern California-based Sienna Biopharmaceuticals filed for bankruptcy Tuesday, which sent share prices tumbling more than 73%. The dermatological drug maker will use Chapter 11 protection to restructure the company, including a possible sale of assets, and will delay development of its Phase III-ready psoriasis treatment."

Commercial

Sienna Biopharmaceuticals Engages Cowen to Explore Financial and Strategic Alternatives (GlobeNewswire, Sienna Biopharmaceuticals, Inc.) - With Cowen's assistance, Sienna will continue to explore capital raising to enable the initiation of its planned Phase 3 pivotal clinical trials for SNA-120 (pegcantratinib), in addition to exploring a wide range of financial and strategic alternatives. Sienna does not intend to initiate its planned Phase 3 trials of SNA-120 until the Company secures sufficient additional capital.

Clinical • Commercial • New trial

Sienna Biopharmaceuticals and SNA-120, pegcantratinib, in psoriasis (SeekingAlpha) - "At the end of Q1/2019, Sienna reported cash and cash equivalents and marketable securities of $57.2M....With a pending Phase 3 study of SNA-120 to be initiated Q4/2019, Sienna will need additional capital. It has a $10M balance from a $40M term loan agreement with Silicon Valley Bank which could be used to extend anticipated increased clinical expenses."

Commercial • New P3 trial

THE ANTI‐CD25 ANTIBODY‐DRUG CONJUGATE CAMIDANLUMAB TESIRINE (ADCT‐301) PRESENTS A STRONG PRECLINICAL ACTIVITY BOTH AS SINGLE AGENT AND IN COMBINATION IN LYMPHOMA CELL LINES (ICML 2019) - P1, P1b; "...ADCT-301 plus the mTOR inhibitor everolimus showed synergism in 4/4 cell lines. Combinations with the PI3K inhibitor copanlisib, the BCL2 inhibitor venetoclax and the HDAC inhibitor vorinostat were synergistic in all but one cell line. The combination with pralatrexate was synergistic in 2/2 ALK-pos ALCL cell lines. The addition of bortezomib or romidepsin led to synergism in 2/4 cell lines. The strong single agent anti-lymphoma activity and the observed in vitro synergisms with targeted agents support the current ADCT-301 clinical development and identify potential combination partners for future clinical studies."

IO Biomarker • Preclinical

SNA-120, A Novel Topical Non-steroidal Therapy for Psoriasis and Associated Pruritus that Targets the NGF/TrkA Pathway: Results from a Multicenter Phase 2b Study (WCD 2019) - No abstract available.

Clinical • Late-breaking abstract • P2b data

Sienna Biopharmaceuticals Announces Late-Breaking Oral Presentation of Phase 2b Trial Results of its Topical, Non-Steroidal TrkA Inhibitor SNA-120 (0.05%) at 24th World Congress of Dermatology (GlobeNewswire, Sienna Biopharmaceuticals, Inc.) - Sienna Biopharmaceuticals...today announced that the results of its recent Phase 2b clinical trial with SNA-120 (pegcantratinib), the Company’s Phase 3 topical, non-steroidal Tropomyosin receptor kinase A (TrkA) inhibitor under investigation for the treatment of psoriasis, will be presented as a late-breaker at the World Congress of Dermatology 2019 Scientific Sessions in Milan.

Clinical • Clinical data • Late-breaking abstract • P2b data • P3 data

Sienna Biopharmaceuticals to present at Dermatology Drug Development Summit Europe (GlobeNewswire) - "Sienna Biopharmaceuticals...today announced that Paul F. Lizzul...and Silvio Traversa...are scheduled to present at the Dermatology Drug Development Summit Europe, May 21-23, 2019, in Frankfurt, Germany. Dr. Lizzul also serves as the Summit’s Chair."

Clinical data

Sienna Biopharmaceuticals Announces SNA-120 (0.05%) Biopsy Data Demonstrate Positive Impact on Key Inflammatory Cytokines, including IL-23 and IL-17, in Psoriasis (GlobeNewswire, Sienna Biopharmaceuticals, Inc.) - P2b, N=500; "Sienna Biopharmaceuticals...today announced biopsy data from its recent Phase 2b clinical trial with SNA-120 (pegcantratinib), the Company’s Phase 3 topical, non-steroidal Tropomyosin receptor kinase A (TrkA) inhibitor under investigation for the treatment of psoriasis....Following Positive End-of-Phase 2 meeting with FDA, Sienna continues toward enrolling first patient in Phase 3 program in second half of 2019..."

Clinical • Clinical data • Enrollment status • New P3 trial • P2b data • Regulatory

Sienna Biopharmaceuticals Reports First Quarter 2019 Financial Results (GlobeNewswire, Sienna Biopharmaceuticals, Inc.) - “We completed a positive End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) for SNA-120 (pegcantratinib) in psoriasis, and the FDA has agreed with us regarding the general Phase 3 study design, including the primary endpoint, the Investigator Global Assessment (IGA) 2-grade composite, which has been the Phase 3 primary endpoint for recent topical psoriasis drugs approved by the FDA and on which we demonstrated clinically meaningful and statistically significant improvement in our recent Phase 2b clinical trial. We continue to work enthusiastically toward enrolling the first patient in our SNA-120 Phase 3 program later this year.”

Clinical • FDA event • New P3 trial • Regulatory