Currency in EUR
Last close As at 28/03/2023
EUR2.14
▲ −0.01 (−0.47%)
Market capitalisation
EUR125m
Research: Healthcare
Oryzon Genomics has announced promising preliminary blinded aggregate safety data from its ongoing Phase IIb PORTICO trial at the 10th European Conference on Mental Health. The study is investigating the use of vafidemstat, the company’s lead asset in central nervous system (CNS) indications, for the treatment of borderline personality disorder (BPD). From the initial randomised 43 enrolled patients, no serious adverse events were reported, indicating that treatment was well tolerated. Additionally, following review by the independent data monitoring committee for PORTICO, the study received approval to continue. We see this as positive for the clinical development of vafidemstat, ensuring the trial remains on track to deliver interim readouts in Q123, representing the next major catalyst for the PORTICO trial. We continue to value Oryzon at €802m, or €15.1/share.
Oryzon Genomics |
Encouraging safety data in PORTICO |
H122 update |
Pharma and biotech |
16 September 2022 |
Share price performance Business description
Analysts
Oryzon Genomics is a research client of Edison Investment Research Limited |
Oryzon Genomics has announced promising preliminary blinded aggregate safety data from its ongoing Phase IIb PORTICO trial at the 10th European Conference on Mental Health. The study is investigating the use of vafidemstat, the company’s lead asset in central nervous system (CNS) indications, for the treatment of borderline personality disorder (BPD). From the initial randomised 43 enrolled patients, no serious adverse events were reported, indicating that treatment was well tolerated. Additionally, following review by the independent data monitoring committee for PORTICO, the study received approval to continue. We see this as positive for the clinical development of vafidemstat, ensuring the trial remains on track to deliver interim readouts in Q123, representing the next major catalyst for the PORTICO trial. We continue to value Oryzon at €802m, or €15.1/share.
Year end |
Revenue |
PBT* |
EPS* |
DPS |
P/E |
Yield |
12/20 |
9.5 |
(4.8) |
(0.07) |
0.0 |
N/A |
N/A |
12/21 |
10.6 |
(7.2) |
(0.09) |
0.0 |
N/A |
N/A |
12/22e |
9.9 |
(7.0) |
(0.10) |
0.0 |
N/A |
N/A |
12/23e |
10.0 |
(7.3) |
(0.10) |
0.0 |
N/A |
N/A |
Note: *Normalised, excluding amortisation of acquired intangibles and exceptional items.
It is estimated that c 1.6% of the US population suffers from BPD; however, with no drugs specifically approved for BPD, treatment for this indication remains an unmet need. As a reminder, the PORTICO study is a randomised, double-blind, placebo-controlled adaptive 14-week trial that aims to assess the efficacy of vafidemstat in the treatment of BPD. The trial’s two primary endpoints aim to measure overall clinical BPD improvement and improvement in aggression symptoms. The latest safety data reported 41 adverse events (AEs) across 12 patients; however, the AEs were only mild with no patient discontinuation. In our view the recorded AEs do not represent a significant risk for the study. Moreover, the data aligns with aggregated safety data from seven previously completed Phase IIa studies, across which 300 patients have been treated with vafidemstat.
The PORTICO trial is currently active in four European countries (2020-003469-20) and the United States (NCT04932291) and aims to enrol up to 156 patients. Interim efficacy data (90 patients) is expected in Q123, with final readouts from the study anticipated in Q423.
Oryzon is also investigating vafidemstat in two further CNS indications, the ongoing Phase IIb EVOLUTION study in schizophrenia and the Phase Ib/II HOPE study in Kabuki syndrome, which is expected to begin recruiting patients in Q123.
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Research: Financials
Gresham House continues to develop its alternative asset management activities with a long-term view, but in the near term its exposure to real assets, long-term fund structures and a sustainability focus mean it is well-positioned to weather current challenging equity market conditions. This is evident in strong H122 results, while the longer-term growth potential remains in place and the group is on track to match or exceed its five-year plan targets.
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