Chat with Filing

Ask questions about this document
Please log in or register to use the chat feature. Please register first.
IP - Arctic Bioscience - 12-måneders data bekrefter potensialet for HRO350 i mild til moderat psoriasis - Attachment: Presentation_HeROPA_12_month_read_out.pdf

Company: Arctic Bioscience Date: 2025-07-01 Language: English Register to download
Loading document preview...
Document Preview Not Available

The file type (.pdf) cannot be displayed directly here.
Open Original File
Error loading document preview. Please try the 'Open Original File' link.
You're One Click Away From The Full Filing

Instantly access this document—and 2.8M more—for free. Select your preferred method:
Continue with Google Continue with Microsoft Continue with Facebook Continue with Amazon
Data read-out July 2025

![](_page_0_Picture_0.jpeg)

# HeROPA study HRO350 in mild-to-moderate psoriasis Arctic Bioscience AS

EU CT number: 2022-501850-12-00 EudraCT number: 2021-003684-96 ClinicalTrials.gov ID: NCT06125808

![](_page_0_Picture_4.jpeg)

## **Foundation for commercial discussions established, subgroups show statistical significance**

Key findings

- Primary endpoint PASI50 difficult to reach due high placebo rate; endpoint sensitive to disease fluctuations (as reported in October 2024)
- Stricter endpoints like PGA 0/1 on per protocol population approaching significance (p = 0.07)
- Relevant subgroups show statistical significance (p < 0.05)
- Robust safety data with no serious concerns observed in the period and HRO350 is well tolerated by the patients
- Combination of statistical significance in subgroups, responder analysis and robust safety data as base for planning future phase III and clinical development
- Promising results going into further partner discussion this fall

# **Primary endpoint PASI50 difficult to measure in mild population**

Natural disease fluctuations and limited precision on lower end of PASI scale makes it hard to show differences in PASI50 between groups for patients with mild-to-moderate psoriasis

mild-to-moderate population (PASI 3-10) who naturally experience seasonal variation and episodes of spontaneous remission or worsening, versus a severe patient with PASI 30 at baseline achieving PASI50 (biologics trial).

![](_page_2_Figure_2.jpeg)

PASI50: The proportion of patients with ≥50% reduction in Psoriasis Area and Severity Index (PASI, scale from 0-72) from baseline. PP: Per Protocol Population for PASI. Week 52 n = 273. Data as observed. ITT: Intention to treat. N = 521, data not shown. p = 0.472 high dose, p = 0.626 low dose (week 52) 1) Papp KA et al., Dermatol Ther (Heidelb) (2021) 11:1079–1083. https://doi.org/10.1007/s13555-021-00572-2

- **Comments**
- **PASI50** compared between HRO350 and placebo at 6 months was the primary endpoint, which was not met
- **Efficacy of HRO350** observed as assumed in protocol for patients who completed 1 year of treatment
- **Placebo response-rate** was much higher than predicted
- **PASI scale** has less precision in mild disease1

# **Stricter endpoint differentiates better: PGA 0/1 (clear or almost clear)**

Key secondary endpoint: Physician's Global Assessment (PGA 0/1) is easier to measure and more difficult to achieve

- Nearly half of patients treated with HRO350 achieved clear-or-almost
- PGA 0/1 is a much harder endpoint to reach than PASI50
- 47% of patients in the high dose arm achieved a PGA 0/1 at week 52, versus 34% in the placebo group (p = 0.073)
- In the previous Haukeland study1 40% of patients achieved PGA 0/1
- All patients had PGA scores ≥ 2 and ≤ 4 at inclusion

Static PGA (sPGA) measures physician's impression at a single time point. Static form is standard due to reliability

![](_page_3_Figure_2.jpeg)

1. Tveit KS et al. Long Term Efficacy and Safety of Herring Roe Oil in the Treatment of Psoriasis, a 39-week Open-label Extension Study. International Journal of Clinical and Experimental Medical Sciences. Vol. 7, No. 1, 2021, pp. 13-20. doi: 10.11648/j.ijcems.20210701.13. 2) 3) Stein Gold L, et al. Efficacy and safety of apremilast in patients with mild-to-moderate plaque psoriasis: Results of a phase 3, multicenter, randomized, double-blind, placebo-controlled trial. J Am Acad Dermatol. 2022 Jan;86(1):77-85. doi: 10.1016/j.jaad.2021.07.040. PMID: 34343599..

PP: Per Protocol population for sPGA for patients who completed 52 weeks: n = 272. Data as observed. ITT: Intention to Treat population for sPGA: N = 521.

(Non-Responder Imputation analysis not shown. p = 0.490 for high dose vs placebo and p = 0.608 for low dose vs placebo)

## **Higher placebo rate in patients with milder disease at baseline**

Subanalysis identified differentiators on placebo response: Baseline severity

- Post-hoc analysis: Placebo response is higher in patients with PASI < 6 at baseline
- Patients with PASI ≥ 6 and < 6 respond similarly in the high dose arm

Static PGA measures physician's impression at a single time point. Static form is standard due to reliability.

![](_page_4_Figure_2.jpeg)

## **Comments**

Post-hoc analysis on the Per Protocol (PP) Population for sPGA. Week 52 n=272. Data as observed. ITT: Intention to treat. N = 521 all time points. (Non-Responder Imputation analysis not shown. p = 0.490, p = 0.995, and p = 0.391 for high dose vs placebo)

## **Lower placebo rate in patients ≥ 50 years**

Subanalysis identified statistically significant subgroup: Impact of age

- Post-hoc analysis: Lower placebo rates ≥ median age( ≥ 50 years)
- Younger age with shorter duration of psoriatic disease may increase chance of spontaneous improvement in the placebo group
- Patients of all ages respond similarly in the high dose arm

![](_page_5_Figure_2.jpeg)

Static PGA measures physician's impression at a single time point. Static form is standard due to reliability Post-hoc analysis on the Per Protocol (PP) Population for sPGA. Week 52 n = 272. Data as observed. ITT: Intention to treat. N = 521 all time points. (Non-Responder Imputation analysis not shown. p = 0.490, p = 0.254, and p = 0.946 for high dose vs placebo)

## **Comments**

# **Higher response rates in active arm for patients with weight ≤ 98 kgs**

Subanalysis identified statistically significant subgroup: Impact of weight

• Post-hoc analysis showed that more patients in lower three weight quartiles (patients weighing ≤ 98 kgs) in PP achieved a PGA 0/1 at week 52 than patients in the highest weight quartile

![](_page_6_Figure_2.jpeg)

Static PGA measures physician's impression at a single time point. Static form is standard due to reliability Post-hoc analysis on the Per Protocol (PP) Population for sPGA. Week 52 n = 272. Data as observed. ITT: Intention to treat. N = 521 all time points. (Non-Responder Imputation analysis not shown. p = 0.490, p = 0.469, and p = 0.868 for high dose vs placebo). Missing weight: n = 2 PBO

## **Comments**

## **Robust safety on HRO350**

## **No Serious Safety Concerns**

No drug-related Serious Adverse Events (SAEs) or Suspected Unexpected Serious Adverse Reactions (SUSARs) were reported

## **Independent Oversight Confirmed Safety**

Periodic reviews by the independent Data Monitoring Committee (DMC) raised no safety concerns throughout the trial

## **Well Tolerated Over 1 Year**

HRO350 demonstrates a favorable safety profile throughout 12 months of treatment and 2 months post-treatment follow-up Few drug-related adverse events (AEs) and low drop-outs due to drug-related AEs Adverse events observed were consistent with expectations and those seen in the Haukeland study

## **Regulatory-Ready Documentation**

Full safety data analysis, including frequency tables and SAE narratives will be detailed in the Clinical Study Report

![](_page_7_Picture_11.jpeg)

- 
- 
- 
- 

**HRO350 safety from HeROPA patients (N = 521) treated for up to 1 year**

Well tolerated with no serious safety concerns

# **Plan going forward**

- Nutra business is growing strongly (~30 % annually)
- We strongly believe there is a major market potential for HRO350 in mild-to-moderate psoriasis
- Arctic Bioscience will seek partnerships for further development of HRO350 with a potential Phase III clinical program

![](_page_8_Picture_4.jpeg)

![](_page_9_Picture_0.jpeg)

![](_page_10_Picture_1.jpeg)

# Appendix

# HRO350 in mild-to-moderate psoriasis Market and value proposition

![](_page_11_Picture_1.jpeg)

\*Split between mild and moderate patients varies in the literature.

Sources: HRO350 Commercial Opportunity Assessment in Psoriasis, IQVIA; WHO Global Report on Psoriasis; Rendon. Int J Mol Sci. 2019 Mar; 20(6): 1475; UpToDate; American Academy of Dermatology Association; Papp. Dermatol Ther. 11:1053; 2021; National Psoriasis Foundation; Evaluate Pharma 2022 Psoriasis Market Size, November 2022 Analysis.

In the U.S.,

In the EU5,

![](_page_12_Picture_9.jpeg)

![](_page_12_Figure_6.jpeg)

~18.7M mild-to-moderate patients in the U.S. and EU5

# **HRO350 Strategic Positioning: mild-to-moderate psoriasis**

- **~22.5M total** psoriasis patients across severity types (~10.7 U.S. and ~11.8 EU5)
- **~80% of U.S.** patients and **~90% of EU5**  patients have **mild-to-moderate** psoriasis
- **HRO350 is targeting a total addressable market of ~18.7M mild-to-moderate psoriasis patients**

![](_page_12_Picture_5.jpeg)

- Drug development program for children <18 years of age with psoriasis
- Component of the regulatory drug development journey for HRO350
- Prerequisite for filing for marketing authorization (MA) for new medicines in Europe

**Limited approved products in standards of care High unmet medical need**

## **Paediatric Investigation Plan (PIP) agreed with the Paedatric Committee\* of the EMA**

• A future paediatric indication would increase patient population who could have benefit from HRO350

• Limited treatment options – potential first line treatment for mild-tomoderate psoriasis in children

- 
- 1% of children under age 18 suffer from psoriasis
- Plan for expanded indication for HRO350
- 
- US

![](_page_13_Picture_12.jpeg)

• Unmet need for oral treatments – only apremilast currently in clinical trials for mild-to-moderate pediatric psoriasis (> 6 yrs) in the

\*The Paediatric Committee of the EMA provides opinions on the quality, safety and efficacy of a medicine for use in the paediatric population

References: Augustin M, Glaeske G, Radtke MA, Christophers E, Reich K, Schäfer I. Epidemiology and comorbidity of psoriasis in children. Br J Dermatol. 2010 Mar;162(3):633-6. doi: 10.1111/j.1365-2133.2009.09593.x. Epub 2009 Nov 18. PMID: 19922529; Haulrig MB, Zachariae C, Skov L. Off-Label Treatments for Pediatric Psoriasis: Lessons for the Clinic. Psoriasis (Auckl). 2021 Feb 11;11:1-20. doi: 10.2147/PTT.S268462. PMID: 33604269; PMCID: PMC7886293.; Menter A, Cordoro KM, Davis DMR, et al. Joint American Academy of Dermatology-National Psoriasis Foundation guidelines of care for the management and treatment of psoriasis in pediatric patients [published correction appears in J Am Acad Dermatol. 2020 Mar;82(3):574]. J Am Acad Dermatol. 2020;82(1):161-201.

![](_page_13_Picture_15.jpeg)

Potential first-line treatment for children with mild-to-moderate psoriasis

# **Paediatric indication for HRO350: upside potential**

PASI: Psoriasis Area and Severity Index (0-72 point scale where >10 is moderate-to-severe and severe disease) Source: HRO350 Commercial Opportunity Assessment in Psoriasis, IQVIA report \*Oral (e.g. fumarates, methotrexate, apremilast) \*\* Injectables (e-g-. adalimumab, ustekinumab, ixkizumab)

![](_page_14_Figure_1.jpeg)

Oral (soft capsules)

- First-in-class active pharmaceutical ingredient (API)
- Mild-to-moderate disease

Few treatment options for non-severe disease

## **HRO350 could meet an unmet medical need for patients with non-severe psoriasis**

# HeROPA study HRO350 in mild-to-moderate psoriasis

Study design

![](_page_15_Picture_3.jpeg)

Large phase IIb study investigated efficacy, safety, and dose of HRO350 versus placebo

# **HeROPA Phase IIb clinical trial design**

- Included **521 patients** started late January 2023 in the UK and March 2023 in Germany, Poland, Finland and Norway
- Protocol designed based on **Scientific Advice from the EMA**

PASI: Psoriasis Area and Severity Index (0–72-point scale where < 10 is mild-moderate disease); RCT: Randomized Controlled Trial. U CT number: 2022-501850-12-00 EudraCT number: 2021-003684-96

b.d. = twice daily; iii = three capsules; DDD = defined daily dose

![](_page_16_Figure_4.jpeg)

|  |                                | Secondary Endpoints at week 52<br>Including Change in PASI |  |                           |  |  |
|--|--------------------------------|------------------------------------------------------------|--|---------------------------|--|--|
|  | Period B : RCT<br>(week 26-52) |                                                            |  | Follow-up<br>(week 52-60) |  |  |
|  |                                |                                                            |  |                           |  |  |
|  |                                |                                                            |  |                           |  |  |
|  |                                |                                                            |  |                           |  |  |
|  |                                |                                                            |  |                           |  |  |
|  |                                |                                                            |  |                           |  |  |
|  |                                |                                                            |  |                           |  |  |
|  |                                |                                                            |  |                           |  |  |
|  |                                |                                                            |  |                           |  |  |
|  |                                |                                                            |  |                           |  |  |

# **HRO350 is a first in class asset with phospholipid esters as API**

**HRO350** is a **unique** lipid matrix with **biologically active phospholipids**

**Proprietary lipid extract** of phospholipid esters from **herring roe** (Clupea harengus)

Manufactured according to **GMP**

**Cellular data** on API and immunomodulation1**-3**

**Active substance (API): PEHeRo** (Phospholipid Esters from Herring Roe) IRIS Substance ID: 300000046327 EV Medicinal Product Code: PRD9919073

Core structure of phospholipid esters from herring roe

*A*

*B*

*D*

*E*

*C*

FATTY ACID

ALCOHOL

GLYCEROL

PO4

*A*

*B*

*C*

*D*

*E*

FATTY ACID

Example phospholipid: PC(22:6n3/16:0)

API: Active Product Ingredient; GMP: Good Manufacturing Practice

References: 1) Forskningsradet (Research Council of Norway), Properties of phospholipids d Herring Roe in Psoriasis, available online 2) Ringheim-Bakka, TA et al. Herring roe PLs promote SPM biosynthesis in macrophages and a keratinocyte/fibroblast co-culture as model of psoriasis, PREPRINT, bioRxiv 2025.02.20.639253; doi: https://doi.org/10.1101/2025.02.20.639253. 3) Mildenberger, J et al. Herring roe oil exerts anti-psoriatic and immunomodulatory effects on the IL-17/23 signaling axis in macrophages, T-cells and a keratinocyte and fibroblast co-culture, PREPRINT, bioRxiv 2025.04.22.650092; doi: https://doi.org/10.1101/2025.04.22.650092.

![](_page_18_Picture_0.jpeg)

# HRO350 Mode of action & resolution of inflammation

![](_page_18_Picture_2.jpeg)

# **Resolve - not block - inflammation: a therapeutic frontier**

## HRO350 API (PEHeRo) promotes SPM biosynthesis in immune cells with implications for the treatment of psoriasis

Specialized pro-resolving mediators (SPMs) are a type of bioactive lipids that actively terminate inflammation and drive the restauration of tissue homeostasis 1

Lipid mediators are **elevated in lesional psoriatic skin**3.

Most existing drugs are designed to reduce inflammation by inhibiting pro-inflammatory cytokines

## Data on SPMs supporting an **anti-inflammatory action of HRO350, and PEHeRo specifically**

• upregulating the production of SPMs which promote a shift towards a protective and possibly reparative phenotype of monocyte-derived macrophages

![](_page_19_Figure_7.jpeg)

Fullerton, J., Gilroy, D. Resolution of inflammation: a new therapeutic frontier. *Nat Rev Drug Discov* 15, 551–567 (2016). https://doi.org/10.1038/nrd.2016.39 Park J, Langmead CJ, Riddy DM. New Advances in Targeting the Resolution of Inflammation: Implications for Specialized Pro-Resolving Mediator GPCR Drug Discovery *ACS Pharmacol. Transl. Sci.* 2020, 3, 1, 88–106; Serhan CN, Chiang N, Dalli J. The resolution code of acute inflammation: Novel pro-resolving lipid mediators in resoluti[on. Seminars in Immunology. 2015 M](https://doi.org/10.1038/nrd.2016.39)ay;27(3):200-215. DOI: 10.1016/j.smim.2015.03.004. PMID: 25857211; PMCID: PMC4515371. Ringheim-Bakka T, Mildenberger J, Dalli J, Saliani A, Petrucelli F, Busygina M, Mancinelli D, Gammelsæter R. Phospholipid Esters from Herring Roe promotes SPM biosynthesis in human monocyte-derived macrophages with implications for the treatment of psoriasis. Poster (37) at the 9th European Workshop on Lipid Mediators, June 26-28th, 2024.

# HRO350 Clinical development plan

![](_page_20_Picture_1.jpeg)

## **HRO350 drug development program in psoriasis** Updated plan

![](_page_21_Figure_1.jpeg)

## HeROPA investigators and clinics:

## **Norway:**

Haukeland University Hospital Ålesund hospital Stavanger University Hospital Nordlandssykehuset

## **United Kingdom:**

Salford Royal hospital Kiltearn Medical Centre Newquay Health Centre Waterloo Medical Centre Heart of Bath Surgery University Hospitals Dorset Sherbourne Med Centre University Hospital of Durham The practice of health Trowbridge Health Centre St Clare Medical centre Kingsmill Hospital Lakeside Medical Research Suffolk Primary Care - Haven Health Breckland Alliance - Grove Surgery Concord Medical Centre Royal Primary Care Ashgate Honiton Surgery Hathaway Medical Centre Rowden Surgery West Walk Surgery Clarence Medical Centre Carn to Coast Health Centres

> **Finland:** CRST Helsinky Oy CRST Turku Oy

## **Germany:**

Fachklinik Bad Bentheim Derma-Study-Center-FN GmbH Universitätsklinikum Münster (UKM) Hautarztpraxis Dr. med. Matthias Hoffmann Universitätsklinikum Heidelberg TU Dresden Haut- und Laserzentrum Hunsrück Studienzentrum Dr. Leitz Tri-Derm Pro Derma University Clinic UKSH Kiel Isa Research Universitätsklinikum Essen Hautmedizin Bad Soden Studienzentrum LMU Klinikum Studienzentrum an der Hase GbR Rosenpark Research GmbH Dermatologie Quist Zentrum für Dermatologie und Ästhetik, Friedrichsdorf Universitätsklinikum Erlangen MensingdermA research GmbH, Hamburg

## **Poland:**

MICS Centrum Medyczne Toruń Klinicznych Centrum Medyczne All-Med KO-MED Centra Kliniczne Sp. z o.o Pulawy Osrodek Wsparcia Badan Klinicznych KOMED at Narodowy Instytut Geriatrii Dermoklinika Centrum Medyczne RENEW Clinic Klinika Ambroziak Klinika Osipowicz I Turkowski sp. zo.o. Dr. Sękowska Klinika Leczenia Bólu Instytut Zdrowia Dr. Boczarska-Jedynak

![](_page_22_Picture_12.jpeg)

## Our CRO:

## Smerud Medical Research International

## Thank you:

Norwegian Research council Innovation Norway Sparebank1 SMN Eksfin

## Our gratitude to the patients who participated in the HeROPA study

# THANK YOU

# **Disclaimer**

Matters discussed in this Presentation may constitute or include forward-looking statements. Forward-looking statements are statements that are not historical facts and may include, without limitation, any statements preceded by, followed by or including words such as "aims", "anticipates", "believes", "can have", "continues", "could", "estimates", "expects", "intends", "likely", "may", "plans", "forecasts", "projects", "should", "target" "will", "would" and words or expressions of similar meaning or the negative thereof. These forward-looking statements reflect the Company's beliefs, intentions and current expectations concerning, among other things, the Company's results of operations, financial condition, liquidity, prospects, growth and strategies. Forward-looking statements involve known and unknown risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future. The forward-looking statements in this Presentation are based upon various assumptions, many of which are based, in turn, upon further assumptions that may not be

accurate or technically correct, and their methodology may be forward-looking and speculative. Company is aware and able to ascertain from the information published by that third party, no

to be inaccurate or misleading.

not to be construed as financial, legal, business, investment, tax or

Recipient acknowledges that it will

solely responsible for forming its own

Company, including the merits and risk involved. This Presentation is not an advertisement for the purposes

implementing the EU Prospectus

and does not contain the same

This Presentation is not a prospectus

level of information as a prospectus.

be solely responsible for its own assessment of the Company, the market and the market position of

the Company and that it will conduct its own analysis and is

opinion of the potential future performance of the Company's business. In making an investment decision, the Recipient must rely on

its own examination of the

of applicable measures

Regulation.

other professional advice. By receiving this Presentation, the

facts have been omitted that would render the reproduced information

The contents of this Presentation are

An investment in the Company's shares should be considered as a high-risk investment. Several factors

could cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievement that may be expressed or implied by statements and information in this

A multitude of factors can cause actual results to differ significantly from any anticipated development

expressed or implied in this

businesses, changes in

factors.

Presentation, including among others, economic and market

and industries that are or will be major markets for Company's

conditions in the geographic areas

governmental regulations, interest

The information obtained from third

rates, fluctuations in currency exchange rates and such other

parties has been accurately reproduced and, as far as the

Presentation.

# Contact

## Arctic Bioscience AS

**Business address:**  Industrivegen 42 6155 Ørsta Norway www.arctic-bioscience.com

CEO: Christer Valderhaug christer@arctic-bioscience.com Phone: +47 92084601

Medical Director: Runhild Gammelsæter runhild@arctic-bioscience.com [Phone: +47 95933436](mailto:Runhild@arctic-bioscience.com)

25