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EUR248m
Research: Healthcare
Oryzon Genomics has reported positive interim data from the Phase Ib FRIDA study, evaluating iadademstat in combination with gilteritinib in advanced acute myeloid leukaemia (AML) patients. Results from the first two cohorts (13 patients) showed a favourable safety profile and efficacy signals, with 69% of patients reporting bone marrow (BM) blast cell clearance in the first cycle. Moreover, 38% of patients achieved complete remission with full or partial hematologic or blood count recovery. While we caution against direct read across between clinical trials, this compares favourably to the 26.3% rate (excluding remissions after bone marrow transplantation during the trial) delivered by gilteritinib in the Phase III ADMIRAL study, potentially supporting the synergy of the combination. Oryzon noted that the first two cohorts achieved full target engagement and indicated the scope for dose reduction (to aid faster platelet recovery) under the FDA’s OPTIMUS guidance. A third cohort is being recruited following this guidance.
Written by
Oryzon Genomics |
Encouraging interim update on FRIDA |
Clinical data update |
Pharma and biotech |
14 June 2024 |
Share price performance
Business description
Analysts
Oryzon Genomics is a research client of Edison Investment Research Limited |
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Oryzon Genomics has reported positive interim data from the Phase Ib FRIDA study, evaluating iadademstat in combination with gilteritinib in advanced acute myeloid leukaemia (AML) patients. Results from the first two cohorts (13 patients) showed a favourable safety profile and efficacy signals, with 69% of patients reporting bone marrow (BM) blast cell clearance in the first cycle. Moreover, 38% of patients achieved complete remission with full or partial hematologic or blood count recovery. While we caution against direct readacross between clinical trials, this compares favourably to the 26.3% rate (excluding remissions after bone marrow transplantation during the trial) delivered by gilteritinib in the Phase III ADMIRAL study, potentially supporting the synergy of the combination. Oryzon noted that the first two cohorts achieved full target engagement and indicated the scope for dose reduction (to aid faster platelet recovery) under the FDA’s OPTIMUS guidance. A third cohort is being recruited following this guidance.
Year |
Revenue (€m) |
PBT* |
EPS* |
DPS |
P/E |
Yield |
12/22 |
15.7 |
(6.3) |
(0.07) |
0.0 |
N/A |
N/A |
12/23 |
14.2 |
(6.0) |
(0.06) |
0.0 |
N/A |
N/A |
12/24e |
12.9 |
(4.1) |
(0.03) |
0.0 |
N/A |
N/A |
12/25e |
33.7 |
15.4 |
0.29 |
0.0 |
6.6 |
N/A |
Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.
The Phase Ib FRIDA study (n=45) is an open-label, single-arm trial assessing iadademstat in combination with gilteritinib as a second-line treatment for relapsed/refractory AML patients harbouring an FMSlike tyrosine kinase 3 mutation. The first part of the study aims to identify the minimum safe and biologically active dose. This will be followed by an expansion stage at the selected dose to assess the efficacy of the combination.
Interim data from the first two cohorts treated over a four-week period (cohort one: n=6, 100μg iadademstat; cohort two: n=7, 75μg iadademstat) was presented at the European Hematology Association Congress. Of the 13 patients treated, 11 were refractory to standard treatments, such as induction chemotherapy, venetoclax and the targeted therapy midostaurin, and two had prior bone marrow transplants. The results demonstrated a favourable safety profile for the combination with no drug-drug interaction, or dose limiting toxicities. Encouraging efficacy signals were observed with 69% of the patients (nine of 13) achieving BM blast leukaemia cell clearance in the first cycle. Roughly 38% of the patients (five of 13) achieved either complete remission (CR), complete remission with partial haematological recovery (CRh) or complete remission with incomplete blood count recovery. This compares favourably to the Phase III results (ADMIRAL study) from the FLT3 inhibitor, gilteritinib, which reported a CR/CRh of 26.3% in the comparable treatment cohort, though we caveat that the results from the FRIDA study will need to be reproduced in randomised studies to confirm superior efficacy.
Management noted that the first two cohorts achieved full LSD1 target engagement (c 90%) supporting the case for dose reduction. This should also aid faster platelet count recovery in the BM, which may result in improved response rates. Cohort three, which has already recruited two participants, will assess the 75μg dose but for a three-week period. We expect rolling updates in H224.
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Research: Financials
S&U’s Q125 trading update disclosed increased pressure as the company steers cautiously through the changing regulatory landscape. The payment rate in the Advantage motor finance business fell to 87.7% from an average 92.1% in FY24, which led to group PBT falling by 34% to £6.9m (Q124: £10.5m) from higher impairments. The negative effects will likely have an impact on future quarters as management expects discussions with the Financial Conduct Authority (FCA) to conclude only in H2 CY24 and lending criteria were tightened at the end of Q1. On the positive side, demand remains strong, with applications at a record high. Moreover, the Aspen bridging business continues to grow rapidly, with Q1 PBT up by 36% y-o-y to a record £1.45m. We have cut our estimates for FY25 EPS by 22% to 179p and FY26 EPS by 15% to 223p for a return on equity (RoE) of 11%.