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Currency in GBP
Last close As at 02/06/2023
GBP1.23
— 0.00 (0.00%)
Market capitalisation
GBP83m
Research: Healthcare
On 9 September 2022 the US FDA approved Bristol Myers Squibb’s first-in-class tyrosine kinase 2 (TYK2) inhibitor Sotyktu (deucravacitinib) for the treatment of moderate-to-severe plaque psoriasis in adults, making it the first selective TYK2 inhibitor to be approved for any indication. We expect this news to have a positive read-across for Sareum Holdings’ lead asset, SDC-1801, a dual TYK2/JAK 1 inhibitor. As a reminder, Sareum recently announced the filing of a clinical trial authorisation application for SDC-1801 with the UK Medicines and Healthcare products Regulatory Agency. The Phase Ia (in healthy subjects) is planned to start in Q4 CY22, and a Phase Ib (in psoriasis patients) is planned to start in CY23 subject to regulatory approval. The approval of Sotyktu was widely expected and validates the potential of this new asset class, in our opinion. Sareum asserts that SDC-1801’s dual targeting could potentially accord superior efficacy, which if proved could translate to a sizeable market opportunity for Sareum.
Sareum Holdings |
Sotyktu approval positive read-across for SDC-1801 |
Regulatory update |
Pharma and biotech |
13 September 2022 |
Share price performance
Business description
Analysts
Sareum Holdings is a research client of Edison Investment Research Limited |
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On 9 September 2022 the US FDA approved Bristol Myers Squibb’s first-in-class tyrosine kinase 2 (TYK2) inhibitor Sotyktu (deucravacitinib) for the treatment of moderate-to-severe plaque psoriasis in adults, making it the first selective TYK2 inhibitor to be approved for any indication. We expect this news to have a positive read-across for Sareum Holdings’ lead asset, SDC-1801, a dual TYK2/JAK 1 inhibitor. As a reminder, Sareum recently announced the filing of a clinical trial authorisation application for SDC-1801 with the UK Medicines and Healthcare products Regulatory Agency. The Phase Ia (in healthy subjects) is planned to start in Q4 CY22, and a Phase Ib (in psoriasis patients) is planned to start in CY23 subject to regulatory approval. The approval of Sotyktu was widely expected and validates the potential of this new asset class, in our opinion. Sareum asserts that SDC-1801’s dual targeting could potentially accord superior efficacy, which if proved could translate to a sizeable market opportunity for Sareum.
Year end |
Revenue (£m) |
PBT |
EPS |
DPS |
P/E |
Yield |
06/18 |
0.0 |
(1.5) |
(0.06) |
0.0 |
N/A |
N/A |
06/19 |
0.0 |
(1.5) |
(0.05) |
0.0 |
N/A |
N/A |
06/20 |
0.04 |
(1.0) |
(0.03) |
0.0 |
N/A |
N/A |
06/21 |
0.0 |
(1.5) |
(0.05) |
0.0 |
N/A |
N/A |
Source: Company data
Sotyktu’s approval was based on the results from the Phase III POETYK PSO-1 and POETYK PSO-2 trials, which evaluated the safety and efficacy of a 6mg/day dose of Sotyktu with placebo and the current mainstay, Otezla (30mg twice daily). POETYK PSO-1 enrolled 664 patients, while POETYK PSO-2 included 1,020 patients. The co-primary endpoints were the percentage of patients achieving PASI 75 (or a 75% skin clearance on the psoriasis area and severity index) and the percentage of patients achieving a static Physician's Global Assessment score of 0 or 1 at week 16. At week 16, 58.7% and 53.6% of patients on Sotyktu achieved a PASI 75 response versus the respective 12.7% and 9.4% receiving placebo and 35.1% and 40.2% of patients on Otezla across both trials. More importantly, the drug showed no material toxicology issues, which has been a particular concern regarding the JAK class of drugs recently, resulting in black box warnings.
Around 2–3% of the global population is believed to be suffering from psoriasis with an estimated eight million patients in the United States alone. The global psoriasis market was valued at US$24.3bn in 2021 and is estimated to reach US$47.2bn by 2029, highlighting the significant market potential.
Sotyktu’s FDA approval was widely expected following data readouts from the two head-to-head clinical trials and validates the potential for the TYK2 class. We note that Sotyktu’s mechanism of action (allosteric approach) is different from SDC-1801’s traditional ATP approach although the latter’s dual selectivity could result in broader inhibition and potentially superior efficacy to Sotyktu. SDC-1801’s Phase Ia trial is expected to start in Q4 CY22.
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Research: TMT
MotorK is a European software-as-a-service (SaaS) provider of sales and marketing software that helps automotive retailers to bridge the gap between their digital capabilities and the expectations of their customers. It is the only European player to offer a range of products on one platform, SparK, simplifying the implementation of digital strategies for the entire sales process at a low cost for both dealers and manufacturers. We forecast rapid revenue growth and margin expansion as MotorK broadens its product suite, expands geographically and executes its M&A strategy.
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