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Asset Brief

SOF-SKN

NOX·Noxopharm·Cutaneous lupus erythematosus (inflammatory skin disease driven by autoimmune activity)·Phase 1·NCT07072611·Primary completion: 1 Feb 2026

Plain-language Brief

The trial in plain terms

The disease: Cutaneous lupus erythematosus (CLE) is a chronic autoimmune condition in which the immune system attacks the skin, causing inflammation, rashes, and scarring. It can occur independently or alongside systemic lupus erythematosus, which affects multiple organs. CLE encompasses several subtypes, including discoid lupus, which can cause permanent skin damage if untreated. Current management relies on sun protection, topical corticosteroids, antimalarial drugs such as hydroxychloroquine, and immunosuppressants.
What the asset is trying to do: SOF-SKN is a topical cream formulation of idronoxil, a small molecule that inhibits sphingosine kinase (SphK), an enzyme involved in regulating inflammation and cell survival signalling. By inhibiting SphK at the skin surface, SOF-SKN is designed to reduce local inflammatory activity without the systemic exposure associated with oral or injectable therapies. This topical approach differs from approved systemic agents used in CLE, which carry systemic side-effect profiles. The asset belongs to the kinase inhibitor class.
What the trial is measuring, and why it matters: The HERACLES trial (NCT07072611) is a first-in-human study enrolling healthy volunteers to evaluate the safety, tolerability, and pharmacokinetics (PK, meaning how the drug is absorbed, distributed, and cleared by the body) of SOF-SKN. The trial uses a SAD/MAD design, meaning participants receive a single dose first and then, in separate cohorts, multiple doses, to characterise how the drug behaves at escalating concentrations before it is tested in patients with CLE. Safety and PK data from healthy volunteer studies are standard prerequisites before advancing to disease populations.
Efficacy benchmarks in this setting: No therapies are currently approved specifically for CLE as a standalone indication in Australia or the United States, though hydroxychloroquine and some immunosuppressants are used off-label or under broader lupus approvals (per U.S. Food and Drug Administration approval records). In randomised trials of CLE, the Physician Global Assessment and Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) are standard outcome measures; published placebo-controlled data for hydroxychloroquine and anifrolumab in CLE patient populations have reported reductions in CLASI activity scores, but specific figures vary by trial design and patient population and are not cited here without a named study reference. Because the HERACLES trial enrols healthy volunteers and measures PK and safety rather than efficacy, any early pharmacokinetic figures from this study are not statistically or methodologically comparable to efficacy endpoints reported in patient trials.

Trial Design

Design summary

Phase: Phase 1
Design type: Open-label, single-centre (Melbourne), dose-escalation. Single-arm with placebo comparator within cohorts. SAD/MAD design in healthy volunteers.
Primary endpoint: Safety, tolerability, and pharmacokinetics of SOF-SKN (per ClinicalTrials.gov NCT07072611)
Key secondary endpoints: [ TODO: fill in ]
Enrolment target: 32 healthy participants across four dose cohorts (0.25%, 0.5%, 1%, 2%) (per ClinicalTrials.gov NCT07072611)
Current enrolment status: Recruiting (per ClinicalTrials.gov NCT07072611); specific number enrolled to date is [ TODO: fill in ]
Sites: Melbourne, Australia (per asset notes); number of sites [ TODO: fill in ]
Expected readout window: Primary completion date listed as 2026-02-01 (per ClinicalTrials.gov NCT07072611); the June 2026 manufacturing announcement suggests trial activity is ongoing, and the precise readout timing is [ TODO: fill in ]

Asset Track Record

Did NOX deliver against its own guidance?

Past catalysts on this ticker, reconciled against the announcement parse pipeline. Hover any row for the parsed outcome detail.

6 July 2026regulatory decisionSOF-SKN™ FDA — Pre-IND meeting request with US FDAhit · positivesrc ASX ↗
8 June 2026otherSOF-SKN manufacturing begins to ensure clinical trial readihitsrc ASX ↗
25 May 2026otherNew data confirms cancer-fighting potentialhitsrc ASX ↗
7 May 2026financingProposed issue of securities - NOXhitsrc ASX ↗
5 May 2026regulatory decisionSOF-SKN™ FDA — Noxopharm progresses US regulatory strategyhit · positivesrc ASX ↗
13 Apr 2026data readoutResults posted — Safety, PK and Efficacy of NOX66 as a Monotherapy and Combined With Carboplatin hitsrc
13 Apr 2026data readoutResults posted — Safety and Tolerability of NOX66 in Combination With Palliative Radiotherapy in hitsrc ASX ↗
13 Apr 2026data readoutResults posted — A Study of NOX66 and External Beam Radiotherapy in Patients With Metastatic Casthitsrc

Class Catalyst Calendar

What's landed, what's next for SOF-SKN and peers

SOF-SKN's own upcoming catalysts alongside class-defining historical readouts and upcoming primary completion dates in the same mechanism classes. Each event moves the broader thesis for SOF-SKN.

ConferenceAACR Annual Meeting 2026· ChicagoApr 2026
ConferenceASCO Annual Meeting 2026· ChicagoMay 2026
Today
SOF-SKNPre-IND meeting with US FDA for SOF-SKN™

Trial design comparison

How SOF-SKN reads against active peer trials

Same axes, same units. Discontinued and historical pivotal trials excluded; see Competitor Landscape below for the full set.

Trial	Sponsor	Class	Phase / Line	Design	Primary endpoint	Dosing	Key eligibility	n
SOF-SKN	Noxopharm	Kinase Inhibitor	Phase 1[ TODO: fill in ]	Open-label, single-centre (Melbourne), dose-escalation. Single-arm with placebo comparator within cohorts. SAD/MAD design in healthy volunteers.	Safety, tolerability, and pharmacokinetics of SOF-SKN (per ClinicalTrials.gov NCT07072611)	Topical cream applied across four concentration cohorts (0.25%, 0.5%, 1%, 2%), single ascending dose and multiple ascending dose (SAD/MAD) design (per ClinicalTrials.gov NCT07072611)	32 healthy participants across four dose cohorts (0.25%, 0.5%, 1%, 2%) (per ClinicalTrials.gov NCT07072611)

Competitor Landscape

Competing programmes by mechanism and phase

Read-across commentary attached per trial. Phase ordering preserved within each group.

Mechanism trade-offs· 2 classes comparedexpand ›

Mechanism	Speed to patient	Manufacturing	Best approved result	Durability	Moat
Antisense oligonucleotideASO	Off-the-shelf	Synthetic	Approved (SMA/DMD)	Chronic dosing	Moderate
Fc Fusion ProteinFc-fusion trap	Off-the-shelf	Biologic	Eylea / Vabysmo class	Dosing-interval driven	High (incumbents)

Curated Commentary

Third-party coverage(none curated yet)

expand ›

External analyst notes, journalism, and industry commentary cited with attribution.

No third-party coverage curated for SOF-SKN yet. Broker coverage of Noxopharm is thin; named analyst notes will appear here as they become available. For now, see the company's ASX announcements and the linked sponsor / class sources elsewhere on this page.

Asset Track Record

Did NOX deliver against its own guidance?

Past catalysts on this ticker, reconciled against the announcement parse pipeline. Hover any row for the parsed outcome detail.

6 July 2026regulatory decisionSOF-SKN™ FDA — Pre-IND meeting request with US FDAhit · positivesrc ASX ↗
8 June 2026otherSOF-SKN manufacturing begins to ensure clinical trial readihitsrc ASX ↗
25 May 2026otherNew data confirms cancer-fighting potentialhitsrc ASX ↗
7 May 2026financingProposed issue of securities - NOXhitsrc ASX ↗
5 May 2026regulatory decisionSOF-SKN™ FDA — Noxopharm progresses US regulatory strategyhit · positivesrc ASX ↗
13 Apr 2026data readoutResults posted — Safety, PK and Efficacy of NOX66 as a Monotherapy and Combined With Carboplatin hitsrc
13 Apr 2026data readoutResults posted — Safety and Tolerability of NOX66 in Combination With Palliative Radiotherapy in hitsrc ASX ↗
13 Apr 2026data readoutResults posted — A Study of NOX66 and External Beam Radiotherapy in Patients With Metastatic Casthitsrc

Class Catalyst Calendar

What's landed, what's next for SOF-SKN and peers

SOF-SKN's own upcoming catalysts alongside class-defining historical readouts and upcoming primary completion dates in the same mechanism classes. Each event moves the broader thesis for SOF-SKN.

ConferenceAACR Annual Meeting 2026· ChicagoApr 2026
ConferenceASCO Annual Meeting 2026· ChicagoMay 2026
Today
SOF-SKNPre-IND meeting with US FDA for SOF-SKN™

Trial design comparison

How SOF-SKN reads against active peer trials

Same axes, same units. Discontinued and historical pivotal trials excluded; see Competitor Landscape below for the full set.

Trial	Sponsor	Class	Phase / Line	Design	Primary endpoint	Dosing	Key eligibility	n
SOF-SKN	Noxopharm	Kinase Inhibitor	Phase 1[ TODO: fill in ]	Open-label, single-centre (Melbourne), dose-escalation. Single-arm with placebo comparator within cohorts. SAD/MAD design in healthy volunteers.	Safety, tolerability, and pharmacokinetics of SOF-SKN (per ClinicalTrials.gov NCT07072611)	Topical cream applied across four concentration cohorts (0.25%, 0.5%, 1%, 2%), single ascending dose and multiple ascending dose (SAD/MAD) design (per ClinicalTrials.gov NCT07072611)	32 healthy participants across four dose cohorts (0.25%, 0.5%, 1%, 2%) (per ClinicalTrials.gov NCT07072611)

Competitor Landscape

Competing programmes by mechanism and phase

Read-across commentary attached per trial. Phase ordering preserved within each group.

Mechanism trade-offs· 2 classes comparedexpand ›

Mechanism	Speed to patient	Manufacturing	Best approved result	Durability	Moat
Antisense oligonucleotideASO	Off-the-shelf	Synthetic	Approved (SMA/DMD)	Chronic dosing	Moderate
Fc Fusion ProteinFc-fusion trap	Off-the-shelf	Biologic	Eylea / Vabysmo class	Dosing-interval driven	High (incumbents)

SOF-SKNn = 32

Noxopharm·Kinase Inhibitor·Phase 1·[ TODO: fill in ]

Design: Open-label, single-centre (Melbourne), dose-escalation. Single-arm with placebo comparator within cohorts. SAD/MAD design in healthy volunteers.
Primary endpoint: Safety, tolerability, and pharmacokinetics of SOF-SKN (per ClinicalTrials.gov NCT07072611)
Dosing: Topical cream applied across four concentration cohorts (0.25%, 0.5%, 1%, 2%), single ascending dose and multiple ascending dose (SAD/MAD) design (per ClinicalTrials.gov NCT07072611)
Eligibility: 32 healthy participants across four dose cohorts (0.25%, 0.5%, 1%, 2%) (per ClinicalTrials.gov NCT07072611)

A Study to Continue the Administration of Deucravacitinib in Participants With Systemic Lupus Erythematosus (SLE) or Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE) Who Have Completed Study IM011074 or Study IM011132n = —

Bristol-Myers Squibb·—·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosusn = —

AstraZeneca·—·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

A Phase III Study to Investigate the Efficacy and Safety of Anifrolumab in Adults With Chronic and/or Subacute Cutaneous Lupus Erythematosusn = —

AstraZeneca·—·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Lenalidomide vs Methotrexate in Difficult-to-treat Cutaneous Lupus Erythematosusn = —

Assistance Publique - Hôpitaux de Paris·—·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Diseasen = —

EMD Serono Research & Development Institute, Inc.·—·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease (ELOWEN-2)n = —

EMD Serono Research & Development Institute, Inc.·—·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

A Long-Term Extension Study to Learn More About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosusn = —

Biogen·—·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

A 2-Part Study to Learn Whether Litifilimab (BIIB059) Injections Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosusn = —

Biogen·—·PHASE2/PHASE3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

A Study to Evaluate Efficacy and Safety of Deucravacitinib in Participants With Active Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE)n = —

Bristol-Myers Squibb·—·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Study to Evaluate the Efficacy of Ruxolitinib 1.5% Cream in Adult Subjects with Discoid Lupus Erythematosusn = —

Innovaderm Research Inc.·—·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study With an Open-Label Extension Evaluating the Efficacy and Safety of VENT-03 in Adult Participants With Active Cutaneous Lupus Erythematosus With or Without Systemic Lupus Erythematosusn = —

Ventus Therapeutics U.S., Inc.·—·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Evaluate the Efficacy and Safety of ICP-488 in Subjects With Cutaneous Lupus Erythematosus (CLE) Double-blind Studyn = —

Beijing InnoCare Pharma Tech Co., Ltd.·—·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

A Study to Assess the Safety, Tolerability, and Efficacy of IMVT-1402 in Participants With Cutaneous Lupus Erythematosus (CLE)n = —

Immunovant Sciences GmbH·—·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

The Willow LTE Study With M5049 in Participants With SCLE, DLE and/or SLE (WILLOW LTE)n = —

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany·—·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

A Phase 1/2a Study of DB-2304 in Healthy Adults and SLE Participantsn = —

DualityBio Inc.·—·PHASE1/PHASE2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

BS
A Study to Continue the Administration of Deucravacitinib in Participants With Systemic Lupus Erythematosus (SLE) or Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE) Who Have Completed Study IM011074 or Study IM011132
Phase 4
Bristol-Myers Squibb·Recruiting·Primary completion 1 Dec 2026·NCT06875960
4 sites
A
Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus
Phase 3
AstraZeneca·Active, not recruiting·Primary completion 22 Aug 2025·NCT04877691
140 sites
367 enrolled
A
A Phase III Study to Investigate the Efficacy and Safety of Anifrolumab in Adults With Chronic and/or Subacute Cutaneous Lupus Erythematosus
Phase 3
AstraZeneca·Active, not recruiting·Primary completion 11 Dec 2026·NCT06015737
188 sites
306 enrolled
AP
Lenalidomide vs Methotrexate in Difficult-to-treat Cutaneous Lupus Erythematosus
Phase 3
Assistance Publique - Hôpitaux de Paris·Not yet recruiting·Primary completion 1 Feb 2029·NCT06965244
0 sites
ES
A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease
Phase 3
EMD Serono Research & Development Institute, Inc.·Recruiting·Primary completion 24 May 2029·NCT07332481
5 sites
PI: Medical Responsibleshared KOL · Responsible
ES
A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease (ELOWEN-2)
Phase 3
EMD Serono Research & Development Institute, Inc.·Recruiting·Primary completion 25 May 2029·NCT07355218
4 sites
PI: Medical Responsibleshared KOL · Responsible
B
A Long-Term Extension Study to Learn More About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus
Phase 3
Biogen·ENROLLING_BY_INVITATION·Primary completion 26 June 2029·NCT06044337
104 sites·2 top centres: Penn / Abramson, Karolinska
B
A 2-Part Study to Learn Whether Litifilimab (BIIB059) Injections Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus
PHASE2/PHASE3
Biogen·Active, not recruiting·Primary completion 20 Oct 2026·NCT05531565
314 sites·4 top centres: Columbia / NYP, Penn / Abramson, +2
BS
A Study to Evaluate Efficacy and Safety of Deucravacitinib in Participants With Active Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE)
Phase 2
Bristol-Myers Squibb·Active, not recruiting·Primary completion 22 Aug 2024·NCT04857034
41 sites
74 enrolledstalled · 339d
IR
Study to Evaluate the Efficacy of Ruxolitinib 1.5% Cream in Adult Subjects with Discoid Lupus Erythematosus
Phase 2
Innovaderm Research Inc.·Recruiting·Primary completion 28 Feb 2026·NCT06261021
2 sites
PI: Robert Bissonnette
VU
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study With an Open-Label Extension Evaluating the Efficacy and Safety of VENT-03 in Adult Participants With Active Cutaneous Lupus Erythematosus With or Without Systemic Lupus Erythematosus
Phase 2
Ventus Therapeutics U.S., Inc.·Recruiting·Primary completion 1 July 2026·NCT07260877
27 sites
BI
Evaluate the Efficacy and Safety of ICP-488 in Subjects With Cutaneous Lupus Erythematosus (CLE) Double-blind Study
Phase 2
Beijing InnoCare Pharma Tech Co., Ltd.·Not yet recruiting·Primary completion 1 Mar 2027·NCT07440537
27 sites
IS
A Study to Assess the Safety, Tolerability, and Efficacy of IMVT-1402 in Participants With Cutaneous Lupus Erythematosus (CLE)
Phase 2
Immunovant Sciences GmbH·Recruiting·Primary completion 1 Apr 2027·NCT06980805
86 sites
MH
The Willow LTE Study With M5049 in Participants With SCLE, DLE and/or SLE (WILLOW LTE)
Phase 2
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany·Active, not recruiting·Primary completion 12 Aug 2028·NCT05540327
122 sites
379 enrolled·PI: Medical Responsibleshared KOL · Responsible
DI
A Phase 1/2a Study of DB-2304 in Healthy Adults and SLE Participants
PHASE1/PHASE2
DualityBio Inc.·Recruiting·Primary completion 23 Mar 2026·NCT06625671