reports
Strategic update on the progress and development of Molecure's key cli...
Strategic update on the progress and development of Molecure's key clinical projects in 2024 Molecure achieved key milestones in the development of its innovative therapies in 2024 and plans to accelerate research and development in its most advanced clinical programs: OATD-01 and OATD-02. A summary of the most important events of 2024: Initiation of Phase II clinical trial (KITE) for OATD-01 in the treatment of pulmonary sarcoidosis at centers in the USA and Europe. Randomization and administration of OATD-01 or placebo to several patients with pulmonary sarcoidosis have been completed.Ef...
Molecure (WSE: MOC) and Nasdaq-listed biotechnology company Ocean Biom...
Molecure (WSE: MOC) and Nasdaq-listed biotechnology company Ocean Biomedical (NASDAQ: OCEA) sign an exclusive licensing agreement for the development and commercialization of selective YKL-40 inhibitors. This license covers first-in-class small molecule YKL-40 inhibitors, including the lead molecule OAT-3912, which has shown potential therapeutic benefits in preclinical models in various cancers as well as inflammatory and fibrotic diseases, offering a novel approach to treating these conditions. In addition, the license covers a patent pending for a molecular screening test for further th...
Molecure receives approval to initiate a Phase II clinical trial (KITE...
Molecure receives approval to initiate a Phase II clinical trial (KITE) for OATD-01 for the treatment of pulmonary sarcoidosis in selected countries of the European Union and Norway OATD-01 is a first-in-class chitotriosidase 1 (CHIT1) inhibitor with the potential to modify the course of disease in sarcoidosis and other interstitial lung diseases.Obtaining regulatory approvals in Denmark, France, Greece, Germany, and Norway enables the conduct of the Phase II clinical trial of OATD-01 in these countries.First administration of OATD-01 in the European Union and Norway is planned for the thir...
Molecure has published its financial report for 2023 - the company has...
Molecure has published its financial report for 2023 - the company has significantly accelerated the development of its clinical and pre-clinical programmes and plans to make strong progress in research in 2024 and 2025 Initiation of Phase II clinical trial of OATD-01 (KITE) for the treatment of pulmonary sarcoidosis following approval from the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).World's first administration of a chitotriosidase 1 inhibitor (or placebo) to a patient with active pulmonary sarcoidosis as part of the Phase...
First patient in the UK is dosed in the OATD-01 Phase 2 KITE study in ...
First patient in the UK is dosed in the OATD-01 Phase 2 KITE study in pulmonary sarcoidosis - OATD-01 is an innovative, first-in-class chitinase inhibitor for the treatment of sarcoidosis among other diseases where chronic inflammation leads to tissue remodeling and fibrosis - In the phase II clinical trial (KITE study), patients will take a daily oral dose of 25 mg OATD-01 or placebo (in tablet form) for 12 weeks - The double-blind, randomised, placebo-controlled study is designed to determine the clinical efficacy, pharmacokinetics, pharmacodynamics and safety of OATD-01 - The P...
- Sean Conroy
Molecure - Termination of coverage
Edison Investment Research is terminating coverage on Molecure (MOC). Please note you should no longer rely on any previous research or estimates for this company. All forecasts should now be considered redundant. Previously published reports can still be accessed via our website.
- Sean Conroy
Molecure - Progressing the validation of mRNA platform
Molecure has announced that it has generated the in vitro proof-of-concept (PoC) data for its mRNA platform, marking a step toward one of its long-term strategic objectives. Based on an in vitro study, management has confirmed the small molecule inhibition of the translation of a protein implicated in cancer via direct binding to mRNA encoding this protein. While the field of RNA-based biopharmaceuticals has gained traction during the pandemic with the use of mRNA vaccines, Molecure is one of th...
- Sean Conroy
Molecure - Q323 report highlights clinical progress
Molecure has released its Q323 report, providing an update on its clinical development activities, particularly around its oral, first-in-class inhibitor, OATD-01. Following the acceptance of the Investigational New Drug (IND) application in July 2023, the Phase II proof-of-concept study (KITE) for OATD-01 in pulmonary sarcoidosis remains on track with the first US patient expected to receive dosing in Q423. Additionally, we anticipate the company to obtain approval to commence recruitment for t...
Molecure Announces Third Quarter 2023 Financial Results and Pipeline H...
Molecure Announces Third Quarter 2023 Financial Results and Pipeline Highlights U.S. Food and Drug Administration (FDA) approval to conduct a Phase II clinical trial for novel chitinase inhibitor OATD-01 in pulmonary sarcoidosis with first patient expected to be dosed in fourth quarter of 2023 Continued enrollment in the Phase I clinical trial of OATD-02, an oral, first in class dual arginase inhibitor for the treatment of cancer with initial data expected early 2024Successful Secondary Public Offering (SPO) raising gross proceeds of approximately PLN50 million (USD12 million) to fund the ...
- Sean Conroy
Molecure - Striving to maximise clinical potential
Molecure has announced H123 results, including a recap of its operational activities. Management also outlined four strategic objectives for 2023–25, with the aim of creating a diversified portfolio of projects (additional details below). Key highlights from the reporting period included updates on the company’s two clinical-stage assets. For OATD-01, management is preparing to commence Phase II studies (initiation expected in Q423), and for OATD-02, the Phase I trial assessing the drug in patie...
Molecure Announces First Half 2023 Results – Significant Financial and...
Molecure Announces First Half 2023 Results – Significant Financial and Operating Momentum Molecure strategy update for 2023-2025 based on the development of a diversified portfolio of innovative research projects with the potential for breakthrough therapies for incurable diseasesCompleted successful Secondary Public Offering (SPO) of gross proceeds of approximately PLN50 million (USD12 million) Proceeds will fund the company through significant development milestones and value inflection pointsFirst patient dosed in Phase I trial with OATD-02, a novel, first in class dual arginase inhibit...
- Sean Conroy
Molecure - Ramp-up in preparation for busy clinical year
In preparation for Molecure’s forthcoming clinical and preclinical R&D activities, management has secured (secondary) financing with a gross value of around PLN50m (c $12m). The Phase II trial for OATD-01, which was recently FDA approved for clinical studies as an Investigational New Drug (IND), is top priority. The company will seek EMA approval in the coming weeks so that it can proceed with Phase II studies in both the US and EU in parallel. It will also employ the proceeds to support the ong...
The U.S. Food and Drug Administration Gives the Green Light to Molecur...
The U.S. Food and Drug Administration Gives the Green Light to Molecure’s Flagship Program – Phase II Clinical Testing of OATD-01 is Ready for Launch Press release The U.S. Food and Drug Administration Gives the Green Light to Molecure’s Flagship Program – Phase II Clinical Testing of OATD-01 is Ready for Launch Molecure can proceed with clinical trials in the U.S.A – Phase II proof-of-concept study will be the first to treat patients suffering from pulmonary sarcoidosis with OATD-01In the coming weeks Molecure will also seek the European Medicine Agency’s approval to conduct phase II cli...
Molecure completes successful Secondary Public Offering (SPO) of appro...
Molecure completes successful Secondary Public Offering (SPO) of approximately PLN 50 million (USD 12 million) with proceeds to be used to fund and build a first in class, sustainable pipeline of breakthrough therapies Press release Molecure completes successful Secondary Public Offering (SPO) of approximately PLN 50 million (USD 12 million) with proceeds to be used to fund and build a first in class, sustainable pipeline of breakthrough therapies Closing of equity offering of 2,776,000 series H shares by private placement, offered within the authorised capital, at an issue price of PLN 1...
- Sean Conroy
Molecure - OATD-01 gearing up for Phase II
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, exp...
Molecure Files an Investigational New Drug (IND) application for lead ...
Molecure Files an Investigational New Drug (IND) application for lead clinical candidate OATD-01 with U.S. FDA ahead of a planned Phase 2 pulmonary sarcoidosis study OATD-01 is a first in class chitotriosidase 1 (CHIT1) inhibitor with disease modifying potential in sarcoidosis and other interstitial lung diseasesClearance of the IND application will pave the way for Molecure to initiate the study in the United States becoming only the second Polish biotech company from Poland ever to do so Warsaw, Poland 23 June 2023 – Molecure S.A. (“Molecure”: WSE: MOC) a clinical stage biotechnology c...
- Sean Conroy
Molecure - Clinical progression ahead in FY23
Molecure is entering FY23 with two active clinical programmes. OATD-01, the company’s lead proprietary asset, is in development for the treatment of sarcoidosis, but management expects to expand into new indications if the data are supportive. The first patient is due to be dosed in the Phase II trial for this asset in H223. Molecure also recently reported the first dosing in the Phase I trial for OATD-02, a novel drug for the treatment of solid tumours; an update for this study is expected in Q...
Molecure Announces Full Year Financial 2022 Results – A Year of Signif...
Molecure Announces Full Year Financial 2022 Results – A Year of Significant Progress Molecure Announces Full Year Financial 2022 Results – A Year of Significant Progress Entering 2023 with strong momentum and a robust pipeline of proprietary, first-in-class compoundsFirst patient dosed in Phase I trial with OATD-02, a novel, first in class dual arginase inhibitor for the treatment of cancer Lead proprietary candidate, OATD-01, a novel chitinase inhibitor in sarcoidosis, expected to advance into a Phase II study with first patient dosed in second half of 2023 Chief Medical Officer Sa...
- Sean Conroy
Molecure - Clinical trials initiated for second asset
As presented at its R&D day in December 2022, Molecure has now initiated the clinical trial for its second candidate, OATD-02. This Phase I trial is an open-label, multi-centre, first-in-human, dose-escalation study. The company will target cancers where immune checkpoint inhibitors (ICIs) have had limited success, an area where we believe OATD-02/ICI combinations could have an impact. In our view, this milestone supports Molecure’s development strategy and we expect an update on this trial in H...
Molecure announces first patient dosed in Phase I trial with novel, fi...
Molecure announces first patient dosed in Phase I trial with novel, first-in-class dual arginase inhibitor OATD-02 for the treatment of cancer Molecure announces first patient dosed in Phase I trial with novel, first-in-class dual arginase inhibitor OATD-02 for the treatment of cancer OATD-02 is an oral, potent and selective dual arginase inhibitor (ARG1 and ARG2) for the treatment of cancerPhase I clinical trial to assess safety, tolerability and preliminary efficacy of OATD-02 in patients with advanced and/or metastatic solid tumors – initial clinical data expected at the end of 2023Seco...
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