SDC-1801 / Sareum, SRI International - LARVOL DELTA

Sareum: Initiation of Toxicology Studies for Lead TYK2/JAK1 Inhibitor, SDC-1801 (Firstwordpharma Press Release) - "Sareum Holdings plc...is pleased to announce the initiation of a programme of toxicology studies for its lead TYK2/JAK1 inhibitor, SDC-1801...The studies, designed to support longer-term dosing of SDC-1801, will investigate the general toxicology and potential of SDC-1801 to interact with other drugs. These are key regulatory requirements ahead of the planned Phase 2 clinical development programme, which is expected to focus initially on psoriasis....The toxicology studies required to prepare for Phase 2 clinical trials are being conducted at an established Contract Research Organisation and are expected to complete in Q4 2025."

New P2 trial • Immunology • Psoriasis

Sareum Holdings Refocuses Strategy After SRA737 Licensing Termination (Business Insider) - "Sareum Holdings plc has announced the termination of the licensing agreement for its cancer drug candidate SRA737 by a U.S.-based biopharma company, effective in March 2025. Despite the setback, Sareum remains committed to advancing its pipeline of TYK2/JAK1 inhibitors, particularly focusing on SDC-1801, which is poised for Phase 2 development, thereby signaling a shift in strategic focus towards its in-house projects."

Commercial • Pipeline update • Solid Tumor

First-in-Human Study of Oral SDC-1801 in Healthy Adults and Adults with Plaque Psoriasis (Parts 1 and 2) (ANZCTR) - P1 | N=80 | Completed | Sponsor: Pharmaceutical Solutions Australia Pty Ltd | Recruiting ➔ Completed

Trial completion • Dermatology • Immunology • Psoriasis

Sareum announces positive results from kinase inhibitor trial (Sharecast) - P1 | N=16 | ACTRN12623000419662 | Sponsor: Sareum Limited | "Sareum Holdings announced positive topline results from its phase 1a clinical trial of SDC-1801....The AIM-traded firm said the trial's multiple ascending dose stage revealed that blood plasma levels of SDC-1801 exceeded predicted therapeutic exposure levels, with a half-life of 17 to 20 hours, indicating potential for once-daily dosing. It said the safety review committee reported no deaths or serious adverse events linked to SDC-1801. Additionally, initial data, which remained blinded, showed no significant changes in blood cell counts or serum creatinine levels, common dose-limiting side effects seen with brepocitinib, a similar TYK2/JAK1 inhibitor."

P1 data • Immunology • Psoriasis

First-in-Human Study of Oral SDC-1801 in Healthy Adults and Adults with Plaque Psoriasis (Part 3 - Food Effects) (ANZCTR) - P1 | N=16 | Completed | Sponsor: Pharmaceutical Solutions Australia Pty Ltd | Not yet recruiting ➔ Completed

Trial completion • Dermatology • Immunology • Psoriasis

Sareum allowed European patent for primary kinase inhibitor asset (Sharecast) - "...Sareum announced on Friday that the European Patent Office had issued a notice of allowance for a patent concerning SDC-1801, its primary TYK2/JAK1 kinase inhibitor currently undergoing clinical trials in Australia. The AIM-traded firm said the patent application reinforced the protection of SDC-1801, particularly in its medical applications for autoimmune disease treatment and specific synthesis methods....While patent applications in the United States and other territories still under review, Sareum said it expected the prompt grant of the patent pending completion of formalities."

Patent • Immunology • Psoriasis • Rheumatoid Arthritis

Sareum reports positive progress in psoriasis programme (Sharecast) - "Sareum announced significant milestones in its phase 1a clinical trial for SDC-1801, its lead programme aimed at addressing autoimmune diseases such as psoriasis, on Thursday. The AIM-traded firm said the completion of the single ascending dose (SAD) phase and the food effect study marked progress in the development of the dual TYK2/JAK1 kinase inhibitor....While the multiple ascending dose study was ongoing, the company said it anticipated the availability of full safety data in the first half of 2024."

P1 data • Trial status • Immunology • Psoriasis

Initiation of food effects study for SDC-1801 (Sareum Press Release) - "Sareum Holdings plc...today announces the dosing of the first subjects in the food effects part of its Phase 1a clinical trial of lead programme SDC-1801. Dosing has started at a specialist clinical unit in Melbourne, Australia. The food effects study is a key part of the Phase 1a trial, designed to determine how the presence of food might affect the absorption and pharmacokinetic profile of SDC-1801. This part of the study will inform whether the drug should be taken with food or on an empty stomach, optimising its potential benefits whilst potentially minimising any possible side effects. This study runs in conjunction with the Single Ascending Dose (SAD) and the Multiple Ascending Dose (MAD) parts of the trial, which are concurrently dosing subjects as planned..."

Trial status • Immunology

Sareum says patent notice in Japan boosts confidence in SDC-1801 (Morningstar UK) - "Sareum Holdings PLC on Friday said it received a notice of allowance from Japan's Patent Office for a patent relating to its lead TYK2/JAK1 kinase inhibitor, SDC-1801. The Cambridge, England-based pharmaceutical company said the Japanese patent, Special Application 2021-543577....Sareum expects the patent to be granted in the 'near future,' subject to certain formalities being completed."

Patent • Immunology • Psoriasis

Sareum says earnings down but product development going well (Morningstar UK) - "...Sareum said it is making good progress with its lead candidate SDC-1801, which inhibits TYK2 and JAK1 to treat various autoimmune diseases, although it is currently focused on psoriasis. A Phase 1a clinical trial, commenced in Australia in May 2023, 'is progressing well' with completion expected by the end of 2024."

Trial completion date • Trial status • Immunology • Psoriasis

First-in-Human Study of Oral SDC-1801 in Healthy Adults and Adults with Plaque Psoriasis (Part 3 - Food Effects) (ANZCTR) - P1 | N=16 | Not yet recruiting | Sponsor: Pharmaceutical Solutions Australia Pty Ltd

New P1 trial • Dermatology • Immunology • Psoriasis

First-in-Human Study of Oral SDC-1801 in Healthy Adults and Adults with Plaque Psoriasis (Part 4 - Adults with Plaque Psoriasis) (ANZCTR) - P1 | N=12 | Not yet recruiting | Sponsor: Pharmaceutical Solutions Australia Pty Ltd

New P1 trial • Dermatology • Immunology • Psoriasis

Sareum begins dosing participants in phase 1a trial for SDC-1801 (Market Screener) - "Sareum Holdings PLC...said it has successfully started the multiple ascending dose part of its phase 1a clinical trial for its SDC-1801 drug, following approval from the safety review committee. The Cambridge-based pharmaceutical company, focused on developing kinase inhibitors to treat autoimmune diseases and cancer, said dosing is taking place at a clinical unit in Melbourne, where participants will take SC-1801 orally once a day for 10 days."

Trial status • Immunology • Psoriasis

First-in-Human Study of Oral SDC-1801 in Healthy Adults and Adults with Plaque Psoriasis (Parts 1 and 2) (ANZCTR) - P1 | N=80 | Recruiting | Sponsor: Pharmaceutical Solutions Australia Pty Ltd | Initiation date: Jun 2000 ➔ Jun 2023

Trial initiation date • Dermatology • Immunology • Psoriasis

Sareum Holdings Plc (SAR Stock) Secured £5 Million Investment (The Market Periodical) - "The Canbridge-based biotechnology company has secured £5 Million for the research & development of its lead candidate SDC -1801. It can be a game-changer therapeutic for autoimmune diseases with an initial focus on psoriasis (a type of skin disease)."

Financing • Immunology • Psoriasis

Sareum doses first subjects in psoriasis drug trial (Market Screener) - "Sareum Holdings PLC...announces successful dosing of first test subjects in a randomised, placebo-controlled phase 1a clinical trial for lead programme SDC-1801....Sareum expects full safety data to become available during the first half of 2024, after which a phase 1b clinical study will commence post-haste if the Phase 1a trial obtains satisfactory results."

P1 data • Trial status • Immunology • Psoriasis

Sareum Holdings plc Announces the Commencement of A Phase 1a Clinical Trial for SDC-1801 (Market Screener) - "Sareum Holdings plc announced the initiation of a Phase 1a clinical trial for its lead product SDC-1801. The trial has started with patient recruitment in progress at specialist clinical units located in Victoria, Australia....Provided satisfactory safety data are obtained from this initial study, a Phase 1b clinical study is expected to commence in psoriasis patients in 2024."

New P1 trial • Trial status • Immunology • Psoriasis

Sareum receives approval to commence SDC-1801 trial in Australia (Clinical Trials Arena) - "Sareum Holdings has received approval for its application submitted for initiation of a Phase I clinical trial of SDC-1801 in Australia. Being developed as a potential new treatment for various autoimmune diseases, SDC-1801 mainly focuses on treating psoriasis, an autoimmune condition that affects the skin. The study will examine the pharmacokinetic properties along with safety of an oral formulation of SDC-1801 in ascending doses given to healthy participants. Upon receiving satisfactory safety data from the study, the company plans to initiate a Phase Ib trial next year in patients with psoriasis."

New P1 trial • Immunology • Psoriasis

Sareum to Participate in the Edison Group’s Global Healthcare “Open House” Virtual Conference (25-27 January 2022) (PharmiWeb) - "Sareum Holdings...announces that the Company will be participating in Edison Group’s Global Healthcare 'Open House' Virtual Conference, taking place on 25-27 January 2022....At the event, Sareum’s Chief Executive Officer, Dr Tim Mitchell, will take part in a virtual interview to discuss the Company’s progress and strategy in 2022 with its lead TYK2/JAK1 inhibitor assets SDC-1801 and SDC-1802, as well as opportunities under consideration by licensee Sierra Oncology to advance Chk1 inhibitor SRA737."

Clinical • Oncology

"#SareumHoldingsPlc reported Subscription to raise £1.63m to progress #SDC1801 $SAR https://t.co/ZCDyZlwXnS" (@1stOncology)

Sareum Holdings: SDC-1801’s Clinical Plan Modified (Investing.com) - "Sareum's lead asset SDC-1801...although the decision to pursue a capsule alternative to the original suspension formulation, at the cost of a further delay in the clinical trial application (CTA) filing (now expected mid-2022)....Management asserts that the new formulation adds value to the programme (removing the need to develop capsules at a later stage) and is supported by £4.6m of funds raised in calendar Q221/Q321....SDC-1801...is on track to complete the final preclinical toxicology studies by the end of 2021 and the company has appointed external consultants to help develop the clinical plan and choose the optimal first indication for the clinical studies..."

Financing • Preclinical • Lupus • Systemic Lupus Erythematosus

"So could Sareum’s TYK2 JAK1 SDC1801 - https://t.co/2FNWgXJQwm" (@CKGeelmuyden)

JAK1 • TYK2

"@GileadSciences some Tyk2 @Sareumplc SDC-1801 & SDC-1802 Covid similar to Lupus & sepsis #CytokineStorm US Dept of Defence/SRI Lupus paper. https://t.co/4oFoAFLxaQ Chinese military saw actual muscle regrowth https://t.co/cAhlevzgMu Tyk2 in sepsis https://t.co/WXvXCVZhTu" (@sra737PRTeam)

Cytokine storm • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • Septic Shock • TYK2

"Tyk2. Top of the 5 to treat #LongCovid #covid19 #covid #coronavirus 2nd on the list, IFNAR2. Inhibited by JAK1. @Sareumplc SDC-1801 & SDC-1802 inhibit both. Tyk2 and JAK1 inhibition You seeing this @GileadSciences @MSDintheUK @GSK @Novartis @TakedaOncology @bmsnews" (@sra737PRTeam)

Infectious Disease • Novel Coronavirus Disease • Oncology

MOVERS OF FRIDAY 23 OCTOBER 2020 (Vox) - "Sareum Holdings (AIM:SAR) shares jumped 23.78% to 1.77p as it awaits US patent for cancer immunotherapy and sees progress across several programmes....Saw a recent breakthrough with autoimmune treatment SDC-1801 through a new formulation that will enable a higher exposure level. An application to commence first human trials is expected to be made during Q1 2021 following successful toxicology studies in rodents which showed ‘excellent tolerability.’"

IND • Preclinical • Stock price • Immunology