BIOX-101 / Bioxodes - LARVOL DELTA

Bioxodes announces positive Phase 2a interim data for BIOX-101 in intracerebral hemorrhagic stroke patients (GlobeNewswire) - P2a | N=23 | BIRCH (NCT05970224) | Sponsor: Bioxodes S.A. | "Bioxodes SA...announces promising interim results from the BIRCH...Interim analysis from the first 16 patients in the standard-of-care controlled, randomized trial showed that primary safety and secondary efficacy endpoints were met. The Data Monitoring Committee (DMC) identified no safety concerns related to changes in ICH volumes, serious adverse events, neurological outcomes, or mortality...Bioxodes will release a second interim report in the second half of 2025, and a final analysis of the study in 2026. The company has stopped recruitment for the trial, as it believes that adding more data would not alter the conclusions based on the available findings....No deaths have so far been recorded in the patient population, a surprisingly positive outcome, and no serious adverse events were attributed to treatment over the course of the trial. Treatment was well-tolerated, with no signs of increased bleeding."

DSMB • Enrollment closed • P2a data • Cerebral Hemorrhage

Bioxodes announces positive Phase 2a interim data for BIOX-101 in intracerebral hemorrhagic stroke patients (GlobeNewswire) - "'We will now launch a Series B funding round, and start the CMC process required to produce sufficient BIOX-101 for the Phase 2b trial. This will take approximately a year to complete, so that we hope to start recruitment in the first half of 2027.'....The company is planning to file for PRIME status with the EMA later in 2025, and for Fast Track designation with the FDA later during development of the product. The planned Phase 2b trial could be sufficient to submit BIOX-101 for conditional marketing authorizations in the U.S. and Europe before 2030."

EMA filing • FDA filing • Financing • New P2b trial • Cerebral Hemorrhage

BIRCH: A Study to Evaluate the Safety, Tolerability and the Effects of Ixodes Ricinus-Contact Phase Inhibitor (Ir-CPI) in Adult Patients With Spontaneous Intracerebral Haemorrhage (clinicaltrials.gov) - P2 | N=23 | Active, not recruiting | Sponsor: Bioxodes S.A. | Recruiting ➔ Active, not recruiting

Enrollment closed • Cerebral Hemorrhage • Hematological Disorders

Bioxodes obtains Orphan Drug Designation for hemorrhagic stroke therapeutic candidate in US and Europe (GlobeNewswire) - "Bioxodes SA...has received Orphan Drug Designation (ODD) for its first-in-class BIOX-101 therapeutic candidate to treat intracerebral hemorrhagic stroke (ICH) from both the U.S. Food and Drug Administration (FDA) and the E.U.’s European Medicines Agency (EMA)....'I am looking forward to achieving our next milestones, including the upcoming interim results from our Phase 2a study of BIOX-101 and the launch of our Series B financing,'...Bioxodes plans to launch a Series B financing round in the second quarter of 2025 to support a potentially registrational Phase 2b trial with BIOX-101 for ICH....Bioxodes is planning to file for PRIME status with the EMA this year, and for Fast Track approval at the FDA later during development of the product."

EMA filing • Financing • Orphan drug • CNS Disorders

Bioxodes secures new funds to reach early 2025 milestones and pursue Series B financing (GlobeNewswire) - "Bioxodes SA...has raised €2.7 million from existing investors in an extension of its Series A funding round, now totaling about €15 million. The proceeds will allow the company to deliver full results from BIRCH, its Phase 2a trial of BIOX-101 to treat intracerebral hemorrhage (ICH)....At the same time, Bioxodes is working to ramp up production of BIOX-101 for a potential registrational international Phase 2b trial, which it plans to launch early next year, with recruitment expected to start in the first quarter of 2027....Bioxodes is launching a series B funding round of about 50 million in Q2 2025, to support CMC and clinical development for BIOX-101, as well as to develop the drug candidate for additional indications including ischemic stroke and undisclosed thrombo-inflammatory diseases."

Enrollment status • Financing • Cardiovascular • Ischemic stroke

BIRCH: A Study to Evaluate the Safety, Tolerability and the Effects of Ixodes Ricinus-Contact Phase Inhibitor (Ir-CPI) in Adult Patients With Spontaneous Intracerebral Haemorrhage (clinicaltrials.gov) - P2 | N=32 | Recruiting | Sponsor: Bioxodes S.A. | Active, not recruiting ➔ Recruiting

Enrollment open • Cerebral Hemorrhage • Hematological Disorders

BIRCH: A Study to Evaluate the Safety, Tolerability and the Effects of Ixodes Ricinus-Contact Phase Inhibitor (Ir-CPI) in Adult Patients With Spontaneous Intracerebral Haemorrhage (clinicaltrials.gov) - P2 | N=8 | Active, not recruiting | Sponsor: Bioxodes S.A. | Recruiting ➔ Active, not recruiting | N=32 ➔ 8

Enrollment change • Enrollment closed • Cerebral Hemorrhage • Hematological Disorders

BIRCH: A Study to Evaluate the Safety, Tolerability and the Effects of Ixodes Ricinus-Contact Phase Inhibitor (Ir-CPI) in Adult Patients With Spontaneous Intracerebral Haemorrhage (clinicaltrials.gov) - P2 | N=32 | Recruiting | Sponsor: Bioxodes S.A. | Initiation date: Jul 2023 ➔ Nov 2023

Trial initiation date • Cerebral Hemorrhage • Hematological Disorders

BIRCH: A Study to Evaluate the Safety, Tolerability and the Effects of Ixodes Ricinus-Contact Phase Inhibitor (Ir-CPI) in Adult Patients With Spontaneous Intracerebral Haemorrhage (clinicaltrials.gov) - P2 | N=32 | Recruiting | Sponsor: Bioxodes S.A. | Phase classification: P2a ➔ P2

Phase classification • Cerebral Hemorrhage • Hematological Disorders

BIRCH: A Study to Evaluate the Safety, Tolerability and the Effects of Ixodes Ricinus-Contact Phase Inhibitor (Ir-CPI) in Adult Patients With Spontaneous Intracerebral Haemorrhage (clinicaltrials.gov) - P2a | N=32 | Recruiting | Sponsor: Bioxodes S.A. | Not yet recruiting ➔ Recruiting

Enrollment open • Cerebral Hemorrhage • Hematological Disorders

BIRCH: A Study to Evaluate the Safety, Tolerability and the Effects of Ixodes Ricinus-Contact Phase Inhibitor (Ir-CPI) in Adult Patients With Spontaneous Intracerebral Haemorrhage (clinicaltrials.gov) - P2a | N=32 | Not yet recruiting | Sponsor: Bioxodes S.A.

New P2a trial • Cerebral Hemorrhage • Hematological Disorders

Evaluation of Hemorrhage and Edema Expansion, Including Effect on Neutrophil-Mediated Neuroinflammation in Intracerebral Hemorrhage, Using Ir-CPI, a Thromboinflammation Inhibitor (ISTH 2023) - "Ir-CPI did not increase PHE and hemorrhage volumes measured by magnetic resonance imaging 1 and 3 days after ICH, as compared to PBS. Ir-CPI decreased neutrophil infiltration and significantly decreased the number of neutrophil-releasing NETs at collagenase injection site (p < 0.05). Ir-CPI also reduced the number of degenerating neurons in the hemorrhagic zone (p < 0.05 at the injection site)."

Cardiovascular • Cerebral Hemorrhage • Hematological Disorders • Inflammation • Thrombosis

IR-CPI REDUCES BRAIN INFILTRATION OF NEUTROPHILS RELEASING EXTRACELLULAR TRAPS AND ATTENUATES NEURONAL DEGENERATION AFTER INTRACEREBRAL HAEMORRHAGE (ESOC 2023) - "Administration of Ir-CPI in mice post-ICH induction is safe, reduces neutrophil infiltration including neutrophil-releasing NETs, and attenuates neuronal degeneration."

Cardiovascular

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ir-CPI in Healthy Male Subjects (clinicaltrials.gov) - P1 | N=32 | Completed | Sponsor: Bioxodes S.A. | Active, not recruiting ➔ Completed | Trial completion date: Jul 2025 ➔ Jan 2023

Trial completion • Trial completion date

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ir-CPI in Healthy Male Subjects (clinicaltrials.gov) - P1; N=32; Active, not recruiting; Sponsor: Bioxodes S.A.

Clinical • New P1 trial