OPM Announces Positive Interim Results of Its Phase 1 Study Evaluating OPM-101 in Healthy Volunteers

Regulatory News:

Oncodesign Precision Medicine (OPM) (ISIN: FR001400CM63; Mnemonic: ALOPM) (Paris:ALOPM), a biopharmaceutical company specializing in precision medicine for the treatment of resistant and metastatic cancer, announces positive interim results at the end of the first part of the Phase 1 single-ascending-dose oral administration (SAD) study of its drug candidate OPM-101 in healthy volunteers.

This first part of the Phase 1 trial was completed in 7 months. 72 healthy volunteers were randomized and OPM-101 was evaluated against placebo using single oral administration at escalating doses (SDA). This study demonstrated that OPM-101 had a significant safety range, as doses tested varied from 5 to 1000 mg, and the maximum tolerated dose was not reached.

Moreover OPM-101 demonstrated significant target engagement over a 24-hour period, starting with low doses. At the end of the SAD, OPM-101 demonstrated excellent tolerability in all cohorts. After a single-dose oral administration of OPM-101 (at doses from 5 to 1000 mg), target engagement was observed at low doses as early as 1 h after administration and maintained at a very significant level over 24 h.

No serious or severe adverse events or dose-limiting toxicities leading to study discontinuation were observed during the SAD part of the study. The few adverse events possibly related to the product were mainly minor, allowing repeated oral administration to be envisaged with confidence.

OPM capitalized on the analysis of OPM-101 data obtained during the SAD to optimize preparation of the second part of the study, scheduled to start in Q4 2023, following ANSM approval:

• OPM-101 is rapidly absorbed orally, with an estimated half-life elimination of 12 to 15 hours, enabling once-daily administration with target engagement above 80%.

• Taking a fat-rich breakfast increased peak concentrations (Cmax) and total exposure (AUC0-t) to the product. Administering OPM-101 after breakfast therefore offers the possibility of administrating lower doses to achieve equivalent levels of target inhibition.

• A dedicated cohort was also used to assess the gender effect, in preparation for the second part of the study, which will focus on repeated administration for 14 days. At the end of each of the seven dose-escalation cohorts, a data review committee agreed to proceed to the next cohort with a higher dose.

Jan Hoflack, Chief Scientific Officer of OPM, said: « OPM-101 was very well tolerated and demonstrated significant target engagement over a 24-hour period, even at low doses. These arguments are in favor of a significant therapeutic range. The Data Review Committee (DRC) reviewed and analyzed all the data obtained during the SDA part of the study and recommended the start of the MDA (repeated administration) part of the study. In this part of the study, OPM-101 will be administered twice a day at doses designed to maintain target engagement above 80%. The MDA part is scheduled to start in early Q4-2023. The completion of this Phase 1 SDA - 9 cohorts in just 7 months highlights the quality of our OPM-101 product and of our preclinical and clinical teams. »