Last close As at 06/08/2026
EUR3.22
▲ −0.05 (−1.41%)
Market capitalisation
EUR77m
Research: Healthcare
OSE Immunotherapeutics (OSE) completed patient recruitment in its Phase IIa study (NCT04605978) investigating its monoclonal antibody therapy, OSE-127/S95011, for the treatment of the autoimmune disease, primary Sjögren’s syndrome (pSS). The trial is sponsored and conducted by OSE’s partner, Servier, and will look to assess the efficacy and safety of OSE-127 in pSS patients with readouts expected in FY23. The drug has already demonstrated a promising safety and tolerability profile in a Phase I study in healthy volunteers. Existing standard-of-care regimes for pSS only treat symptoms of the condition. However, OSE-127 is being developed with the objective of becoming the first disease-modifying therapy for pSS, which may offer significant market differentiation, in our view. We continue to value OSE at €398.4m or €21.5 per share.
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OSE Immunotherapeutics |
OSE-127 Phase II study enrolment completed |
Clinical trial update |
Pharma and biotech |
3 November 2022 |
Share price performance
Business description
Analysts
OSE Immunotherapeutics is a research client of Edison Investment Research Limited |
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OSE Immunotherapeutics (OSE) completed patient recruitment in its Phase IIa study (NCT04605978) investigating its monoclonal antibody therapy, OSE-127/S95011, for the treatment of the autoimmune disease, primary Sjögren’s syndrome (pSS). The trial is sponsored and conducted by OSE’s partner, Servier, and will look to assess the efficacy and safety of OSE-127 in pSS patients with readouts expected in FY23. The drug has already demonstrated a promising safety and tolerability profile in a Phase I study in healthy volunteers. Existing standard-of-care regimes for pSS only treat symptoms of the condition. However, OSE-127 is being developed with the objective of becoming the first disease-modifying therapy for pSS, which may offer significant market differentiation, in our view. We continue to value OSE at €398.4m or €21.5 per share.
Year end |
Revenue |
PBT* |
EPS* |
DPS |
DPS |
Yield |
12/20 |
10.4 |
(18.5) |
(1.02) |
0.0 |
N/A |
N/A |
12/21 |
26.3 |
(16.5) |
(0.89) |
0.0 |
N/A |
N/A |
12/22e |
16.0 |
(27.8) |
(1.28) |
0.0 |
N/A |
N/A |
12/23e |
0.0 |
(44.2) |
(2.42) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.
pSS is an autoimmune disease affecting up to 3.1 million adults globally, with symptoms ranging from mild (dry eyes and mouth) to severe (organ dysfunction). As a reminder, OSE-127 is a monoclonal antibody that acts as an antagonist of the interleukin-7 receptor (CD127) present on the surface of certain immune system T-cells, targeting which results in a downregulation in inflammatory immune response.
OSE is developing OSE-127 in partnership with Servier for the treatment of both pSS and a second Phase II study (NCT04882007) in ulcerative colitis (US) being funded by OSE. Servier has a two-step option to in-license the drug after the completion of the Phase II trials. Having already received a €5m milestone payment in Q321 following inclusion of the first patient in the Phase II pSS study, OSE is still entitled up to a further €250m in milestone payments plus royalties. The next potential milestone is a €15m payment, which OSE would receive should Servier exercise the remainder of the licensing option on completion of the two Phase II studies. Readouts from the UC study are expected in FY23.
The Phase IIa pSS study is a randomized, double-blind, placebo-controlled study and has recruited 48 patients in centres across the United States, Europe and Australia. The trial’s primary endpoint will assess the change in ESSDAI total score at week 13. Additionally, we believe that by targeting niche indications where no disease-modifying treatment options currently exist, OSE-127 may represent a potential first-in-class market opportunity, if positive clinical results are achieved.
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Research: Healthcare
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