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Research: Healthcare
Molecure has filed an Investigational New Drug (IND) application with the US FDA for OATD-01. Clearance of the application will enable the company to initiate a global (US and EU), multi-centre, randomised, double-blind, placebo-controlled Phase II study (expected n=90) to assess the safety and efficacy of OATD-01 in patients with pulmonary sarcoidosis. Management anticipates that the trial will commence in Q423. Results from this double-blind study will be shared once it has been completed, expected to be in H125. We view the filing of this IND application as a key milestone for Molecure, and believe that the results from the trial will be an important catalyst for investor attention.
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Molecure |
OATD-01 gearing up for Phase II
Pharma and biotech |
Spotlight – Flash
26 June 2023 |
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Molecure is a research client of Edison Investment Research Limited |
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Molecure has filed an Investigational New Drug (IND) application with the US FDA for OATD-01. Clearance of the application will enable the company to initiate a global (US and EU), multi-centre, randomised, double-blind, placebo-controlled Phase II study (expected n=90) to assess the safety and efficacy of OATD-01 in patients with pulmonary sarcoidosis. Management anticipates that the trial will commence in Q423. Results from this double-blind study will be shared once it has been completed, expected to be in H125. We view the filing of this IND application as a key milestone for Molecure, and believe that the results from the trial will be an important catalyst for investor attention.
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As a reminder, Molecure’s lead clinical asset, OATD-01, is an oral, first-in-class CHIT1 inhibitor in clinical development for the treatment of sarcoidosis. The drug has the potential to be the first disease-modifying therapy for this indication, which, according to Evaluate Pharma, is projected to be worth c $335m by 2028. Positive safety and biomarker data was reported for OATD-01 in the prior Phase Ib trial. Furthermore, management believes that additional preclinical data are supportive of expanding the asset into other indications such as idiopathic pulmonary fibrosis (IPF) and non-alcoholic steatohepatitis (NASH). We note that Molecure has received orphan drug designation for OATD-01 in sarcoidosis and IPF by the FDA.
Molecure has announced that it has filed an IND application for OATD-01 with the US FDA. A successful IND application will enable the company to initiate the international Phase II proof-of-concept trial, which management plans to initiate in Q423. The results will be shared once this double-blind study has been completed in H125. In prior pre-IND meetings with the FDA, Molecure has confirmed that the primary endpoint will be the response to a 12-week treatment regimen with OATD-01, evaluated by PET/CT imaging looking for a reduction of granulomatous inflammation in the pulmonary parenchyma. We view this as a key milestone for Molecure and the clinical development of OATD-01, and believe that positive results from this trial could represent a major catalyst for the company.
Molecure’s second clinical asset, OATD-02, is engaged in an ongoing Phase I trial. OATD-02 is a small-molecule inhibitor of arginases 1 and 2, therapeutic targets associated with a variety of tumour types. The drug has been designed to restore antitumour immune responses by overcoming the immunosuppressive tumour environment. This Phase I trial is an open-label, multi-centre, first-in-human, dose-escalation study assessing safety and tolerability. In March 2023, Molecure announced that the first patient had been dosed in the study, and we expect to hear an update on the progression of this trial in H223.
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Research: Healthcare
OSE Immunotherapeutics (OSE) has received €1.5m in non-dilutive funding from Bpifrance (a French public sector investment bank) to develop a companion diagnostic test to support the upcoming Phase III clinical trial for Tedopi, its lead cancer vaccine candidate in non-small cell lung cancer (NSCLC) second-line treatment. Management believes the test will help accelerate the clinical development of Tedopi because it will screen the target HLA-A2-positive NSCLC patients for the Phase III trial. We expect this confirmatory and potentially pivotal Phase III study for Tedopi to be initiated by end-FY23/early-FY24, which will mark a significant clinical milestone in our view. If successful, the trial results could bring significant and potential deal value for future licensing opportunities.