SOF-SKN / Noxopharm - LARVOL DELTA

Noxopharm…has advanced its Phase One HERACLES clinical trial of SOF-SKN, confirming that the first multiple-dose cohort has been completed with no clinically significant safety concerns (Proactiveinvestors) - "The company said the Safety Steering Committee found the treatment to be safe and well tolerated. With the first cohort completed, the study will now move to the second and final group of participants, who will receive multiple doses at the highest level approved for this trial. Each cohort comprises four participants who receive a daily application of SOF-SKN for a two-week period. HERACLES is the first-in-human study of SOF-SKN, a new drug candidate intended for autoimmune conditions such as cutaneous lupus erythematosus."

First-in-human • Trial status • Cutaneous Lupus Erythematosus

Noxopharm begins daily dosing in second phase of HERACLES trial (BiotechDispatch) - "The newly commenced second part of the study involves multiple daily doses administered across two sequential cohorts. Each cohort comprises four participants who will apply SOF-SKN once daily for 14 days. The first cohort will receive a lower concentration, after which a Safety Steering Committee will review the data and approve the commencement of the higher-dose cohort."

Trial status • Cutaneous Lupus Erythematosus

Noxopharm advances autoimmune drug trial as HERACLES enters second phase (BiotechDispatch) - "Australian clinical-stage biotechnology company Noxopharm...has commenced the second part of its HERACLES clinical trial, marking another milestone in the development of SOF-SKN, a novel topical therapy targeting autoimmune skin diseases such as cutaneous lupus erythematosus (CLE)...The company confirmed that the trial’s Safety Steering Committee had approved skipping the two lowest dose levels tested in Part A, allowing researchers to begin the next stage at a higher concentration. The decision, made based on favourable safety data, will make the study more efficient and cost-effective, reducing timelines while maintaining scientific rigour....In the new phase, participants will receive daily applications of SOF-SKN over two weeks, with each cohort increasing the dosage as safety data permit."

Trial status • Cutaneous Lupus Erythematosus

Noxopharm advances HERACLES trial for novel autoimmune disease drug (BiotechDispatch) - "The company has completed the second dose cohort, with the safety steering committee determining it to be safe and tolerable. This green light allows the trial to proceed to the third cohort, where participants will receive a higher dose."

Trial status • Cutaneous Lupus Erythematosus

HERACLES clinical trial – Update #1 (Noxopharm Press Release) - "Clinical-stage biotech company Noxopharm Limited...is pleased to announce the first dose cohort of SOF-SKN has been successfully completed in the HERACLES trial....The safety steering committee has determined the first dose level to be safe and tolerable, with no clinically relevant issues found. The trial will therefore now proceed to the second cohort of participants, who will receive a higher dose."

Trial status • Cutaneous Lupus Erythematosus

First SOF-SKN dose in HERACLES clinical trial (Noxopharm Press Release) - "Clinical-stage biotech company Noxopharm Limited...is pleased to announce a major milestone with the first SOF-SKN dose administered in the HERACLES trial...The study aims to evaluate the safety and tolerability profile of SOF-SKN by testing it at four different concentrations, and is taking place in Australia to capitalise on Australian expertise in lupus research and early phase clinical trials. Noxopharm will also secure federal R&D tax benefits by conducting the study locally....The first part of the trial involves four cohorts each with four participants, and a schedule of dose increases from one cohort to the next. The first cohort is now receiving the lowest dose, then a safety steering committee meeting will be held to evaluate the data and determine the next step in the trial."

Trial status • Cutaneous Lupus Erythematosus

HERACLES: Clinical Trial to Evaluate Safety, Tolerability, and Pharmacokinetics of SOF-SKN in Healthy Participants (clinicaltrials.gov) - P1 | N=32 | Not yet recruiting | Sponsor: Noxopharm Limited

New P1 trial • Cutaneous Lupus Erythematosus • Immunology • Inflammatory Arthritis • Lupus

Clinical trial recruitment progressing rapidly (Noxopharm Press Release) - "Clinical-stage biotech company Noxopharm Limited...is pleased to announce that recruitment activities are progressing rapidly and on schedule for the HERACLES clinical trial...The study aims to evaluate the safety profile of SOF-SKN by testing it at four different concentrations, and will take place in Australia to capitalise on Australian expertise in lupus research and early phase clinical trials. Noxopharm will also secure federal R&D tax benefits by conducting the study locally....The recruitment phase involves a wide array of activities such as advertising the trial to potential subjects, as well as the identification, pre-screening, and later full screening of participants to ensure they meet all eligibility criteria before formal enrolment....As part of the initial trial activities, representatives from Noxopharm, the team at Doherty Clinical Trials and other relevant parties have already completed their mandatory training."

New P1 trial • Cutaneous Lupus Erythematosus

Noxopharm secures green light for HERACLES clinical trial (BiotechDispatch) - "Noxopharm...has been granted approval by the Human Research Ethics Committee for the HERACLES clinical trial following a straightforward review process...HERACLES will be a first-in-human trial of Noxopharm's SOF-SKN, a novel drug candidate for chronic inflammatory diseases...The study aims to evaluate the safety profile of SOF-SKN by testing it at four dierent concentrations. It will take place in Australia to capitalise on local expertise in research for inflammatory diseases such as lupus, as well as early-phase clinical trials....The company stated that it will work closely with the Doherty Clinical Trials team in Melbourne to expedite the operational aspects of the trial. These include activities such as undertaking site initiation, preparing and shipping the trial-specific batches of SOF-SKN, and screening and recruiting trial participants."

New P1 trial • Cutaneous Lupus Erythematosus • Lupus

SOF-SKN, a Novel Topical Anti-Inflammatory Therapeutic Targeting Toll-Like Receptors 7 and 8 (ARA 2025) - "Topical delivery of our novel, ultra-short oligonucleotide therapeutic SOF-16 can effectively dampen TLR7-driven skin inflammation in mice. SOF-16 formulated as SOF-SKN is currently in pre-clinical development with a first-in-human study to assess the safety and tolerability of SOF-SKN, titled HERACLES (Harnessing Endogenous Regulators Against CLE Study), to begin in 2025."

IO biomarker • Cutaneous Lupus Erythematosus • Dermatitis • Immunology • Inflammation • Inflammatory Arthritis • Lupus • Psoriasis • TLR8

SOF-SKN data presented at rheumatology conference (Noxopharm Press Release) - "Building on earlier testing during the drug development process, the new data presented at the conference employed the same approach to study the final version of SOF-SKN that will be used in the upcoming HERACLES clinical trial...In the study, a model of TLR7-driven skin inflammation was created by applying Aldara cream containing 5% imiquimod (a TLR7 agonist) topically to the backs of mice. Aldara induces skin inflammation via the same immune sensors that are responsible for lupus. SOFSKN was also applied onto the same areas in half of the tested group....Mice were scored daily for the appearance and severity of skin inflammation using an industry standard system (PASI score), and the results showed that while Aldara created strong inflammation, the topical administration of SOF-SKN significantly reduced visible signs of skin irritation."

Preclinical • Cutaneous Lupus Erythematosus

Noxopharm clinical trial submission (Noxopharm Press Release) - "Innovative biotech company Noxopharm Limited...is pleased to announce that following successful preclinical testing, it has now applied for Human Research Ethics Committee (HREC) approval for the HERACLES clinical trial...The submission of a comprehensive preclinical data package, the clinical protocol and other supporting documentation will be reviewed by the HREC, and a decision is expected after a review period of several weeks. Noxopharm will keep shareholders informed of the outcome in a timely fashion...The HERACLES clinical trial will be a first-in-human trial for SOF-SKN, a novel drug candidate for autoimmune diseases. The study aims to evaluate the safety profile of SOFSKN by testing it at four different concentrations, and will take place in Australia to capitalise on Australian expertise in lupus research and early phase clinical trials. Noxopharm will also secure federal R&D tax benefits by conducting the study locally."

New P1 trial • Cutaneous Lupus Erythematosus • Immunology

Noxopharm announces SOF-SKN successfully passes nal pre-trial study (BiotechDispatch) - "Noxopharm...has announced that its SOF-SKN lupus medication has passed its final in vivo preclinical safety study before regulatory submission for the upcoming HERACLES clinical trial...The study examined numerous safety and toxicity criteria to ensure that there were no clinically relevant adverse eects and that the drug would be considered safe to give to trial participants....Noxopharm said that beyond the standard clinical observations, the study involved a comprehensive battery of tests and measurements covering cardiac, respiratory and neurological functions, dermal toxicity, haematology, serum chemistry, toxicokinetics, and histopathology of all vital organs and tissues."

Preclinical • Lupus

Noxopharm expands collaboration with Hudson Institute (BiotechDispatch) - "Noxopharm...has announced an expanded work program for 2025 with its strategic partner, Melbourne’s Hudson Institute of Medical Research...The partnership and in-licensed technology are components of Noxopharm's Sofra platform, via which it is developing a portfolio of assets, including the SOF-SKN topical skin medication for lupus and the SOF-VAC program for mRNA vaccines and therapeutics enhancement...Noxopharm said the updated contract will enable it and the Hudson Institute team to advance the Sofra platform further. This includes expanding research into critical inflammation sensors such as TLR7, TLR8, RIG-I, and cGAS and exploring promising targets such as TLR3 and TLR9."

Licensing / partnership • Cutaneous Lupus Erythematosus

Noxopharm confirms the location of phase 1 HERACLES clinical trial (BiotechDispatch) - "Australian biotechnology company Noxopharm...has engaged Doherty Clinical Trials to conduct its upcoming phase 1 HERACLES trial...The trial will take place in Melbourne and be conducted by Doherty Clinical Trials, a specialist not-for-profit organisation established by the Peter Doherty Institute for Infection and Immunity....HERACLES is the first-in-human trial of Noxopharm's novel drug candidate for autoimmune diseases, SOF-SKN. The trial will study the Australian company's candidate for the skin disease that is caused by cutaneous lupus erythematosus (CLE)."

New P1 trial • Cutaneous Lupus Erythematosus

Noxopharm Reports FY2025 Half Year Results (Noxopharm Press Release) - "Noxopharm finished the period with $1.0m in cash, and is reviewing expenditure in the best interests of the company and its shareholders...There has been investment in R&D of $1.6m (1HFY24: $1.5m) to advance drug discovery and preclinical studies. All areas of expense are being carefully monitored....'Our focus right now is on preparing for the upcoming HERACLES clinical trial for our SOF-SKN lupus drug candidate...'"

Financing • New trial • Lupus