- The Independent Data Monitoring Committee (IDMC) recommended continuation of the global Phase II PoC study in patients with active pulmonary sarcoidosis without changes to the current protocol.
- The recommendation followed the IDMC's review of the complete safety and efficacy dataset for an interim analysis in 30 patients.
- Based on unblinded data, a futility analysis indicated sufficient probability of achieving the primary endpoint-based on differences in PET/CT imaging-and selected secondary endpoints.
- Preliminary biomarker analysis of blinded data showed inflammatory biomarker trends consistent with OATD-01's expected biological response.
- Molecure is currently randomizing 20 additional patients for the second and final interim analysis, which will involve a statistical re-evaluation of the required trial size.
- The positive recommendation should boost patient recruitment and ongoing business development discussions for the accelerated development of OATD-01..
WARSAW, Poland, Aug. 03, 2026 (GLOBE NEWSWIRE) -- Molecure S.A. (WSE: MOC), a clinical-stage biotechnology company, has received a positive recommendation from the IDMC to continue the Phase II KITE clinical trial without protocol changes. The trial evaluates the efficacy and safety of OATD-01, a first-in-class CHIT1 inhibitor, in active pulmonary sarcoidosis patients.
The IDMC reviewed data collected following the 12-week treatment period for the first 30 patients receiving either OATD-01 or a placebo, recommending that the trial continue in its current form.
"The IDMC recommendation is highly reassuring at this stage. The Committee recommended that KITE continue without any changes to the protocol, which suggests that the study has a good chance of achieving its primary efficacy endpoint and meets the required safety criteria," said Dr. Marcin Szumowski, CEO of Molecure S.A. "From a business perspective, the IDMC recommendation, along with the observed biomarker trends and favorable safety profile, strengthens our position in ongoing partnering discussions following the strong interest we received during the BIO International Convention."
Biomarker analysis is an important component of this early trial stage. The Company analyzed blinded data from 23 patients, focusing on inflammatory biomarkers. The observed trends suggest anti-inflammatory activity, though definitive conclusions cannot be drawn until the study is unblinded.
- I am very gratified to hear about the positive IDMC recommendation and the progress in the KITE study," said Daniel Culver, one of the world leading lung sarcoidosis experts from Cleveland Clinic, one of the largest reference centers for pulmonary sarcoidosis. "I was also highly impressed with the biomarker data. These data are consistent with the possibility that there are between-group differences related to the study drug for biomarkers of sarcoidosis inflammation. It is exciting to see that a study for a novel mechanism of action and innovative trial design is making good progress The clinicians and the patients are all looking forward to seeing unblinded results when it is completed." adds dr. Culver
"Despite the limitations of the double-blind nature of the study the changes observed in selected inflammatory biomarkers are highly encouraging," said Dariusz Stencel, MD, PhD, CMO of Molecure. "These findings reinforce our confidence in the asset's potential for further development and will support further patient recruitment."
The KITE study is a double-blind, placebo-controlled Phase II trial conducted at nearly 30 sites across the US, EU, Norway, and the UK, evaluating a fixed 25 mg dose of OATD-01 over 12 weeks. OATD-01 has therapeutic potential in interstitial lung diseases, including sarcoidosis and idiopathic pulmonary fibrosis, as well as MASH.
About Molecure S.A.
Molecure S.A. is a clinical-stage biotechnology company developing first-in-class small-molecule therapies for currently incurable diseases. Molecure's pipeline includes OATD-01 for interstitial lung diseases (Phase II) and OATD-02, a dual arginase inhibitor for cancer (Phase I). The Company is headquartered in Warsaw and listed on the Warsaw Stock Exchange.
Further information is available at: molecure.com
LinkedIn: Molecure | Twitter: @molecure_sa | YouTube: Molecure SA
