Treatment of Post-Punch Biopsy Bleeding in Apixaban-Treated Patients Using Self-Administered BXP154B

Randomized, Double-Blind, Placebo-Controlled, 2-Way Crossover Study to Evaluate the Efficacy and Safety of BXP154B (Tranexamic Acid Sterile Topical Solution) in the Treatment of External Bleeding From Minor Wounds in Subjects on Apixaban

The goal of this clinical trial is to test if the study drug, BXP154B works to stop bleeding from a minor wound in patients that are on apixaban for anticoagulant therapy. The main questions it aims to answer are:

• How long does it take to stop bleeding after BXP154B is applied to a wound?
• How many people require the use of a rescue treatment to stop bleeding?
• Does BXP154B reduce instances of re-bleeding after the bleeding has stopped initially?
• Is BXP154B safe and well-tolerated?

Oral anticoagulant-related clinically relevant nonmajor bleeding (CRNMB; i.e., non-major bleeding that requires medical intervention, increased level of care, or face-to-face evaluation) and minor bleeding, often referred to as 'nuisance' bleeding, carries a high burden in terms of patient discomfort, anxiety, temporary disability, and reduced quality of life, and strain on medical and socioeconomic resources. Prolonged bleeding following minor injuries (falls, scrapes, cuts) can be life-interrupting and frequently leads patients to seek medical care, often times in an urgent care or emergency department (ED) setting. Prolonged bleeding from minor injuries is a significant challenge to daily life for people on anticoagulants, and is anything but 'minor' to the patient.

Bio 54, LLC, is developing BXP154B, a topical agent intended for self-administration (in or outside the home) to treat external bleeding from minor wounds in patients on anticoagulants. The development of BXP154B will offer patients on anticoagulants a much-needed treatment for self-management of external bleeding from minor wounds at home.

BXP154-201 is a randomized, double-blind, placebo-controlled, 2-way crossover-design study to evaluate the efficacy and safety of BXP154B (6 mL) compared with volume-matched placebo in the treatment of bleeding following punch biopsy in subjects on apixaban.

Subjects will be enrolled in this clinical trial for a total of seven days, following a screening period of up to 28 days. The study commences on Day 1 with a skin punch biopsy and administration of the investigational drug or placebo. Subsequently, follow-up assessments will be conducted on Days 2, 3, and 4. A second skin punch biopsy will be performed on Day 4, followed by additional follow-up assessments on Days 5, 6, and 7. Upon completion of the Day 7 assessments, subjects will have fulfilled their involvement in the study.

Inclusion Criteria:

• Male or female ≥18 years of age on the day of signed informed consent. At least 8 subjects of each sex will be enrolled.
• Currently receiving apixaban (Eliquis®) and on a BID dosing regimen 5 mg BID (10 mg total daily dose). Subjects must have been on the same dosing regimen for at least 7 days prior to Day 1.
• Willing and able to provide informed consent prior to any study procedures and to comply with all aspects of the protocol

Exclusion Criteria:

• Allergy or sensitization to any components of BXP154B
• BMI ≥ 50 kg/m2
• Known genetic/familial hypercoagulable disorder
• Thrombocytopenia (platelets <75,000/mm3)
• Subjects using any prescribed chronic drug therapies that impact platelet function including clopidogrel (Plavix®), prasugrel (Effient®), ticagrelor (Brillinta®), dipyridamole (Aggrenox®), cilostazol (Pletal®), aspirin, or any non-steroidal anti-inflammatory drugs (NSAIDs; e.g., ibuprofen, naproxen, diclofenac, indomethacin, ketorolac, etc.) are excluded from participation in the study. NSAIDs or aspirin taken on an as needed (PRN) basis must be discontinued according to the following required windows prior to Day 1 (aspirin, 7 days; ibuprofen, 24 hours; all other NSAIDs, 4 days) and may not be taken for the duration of the study.
• Use of any other anticoagulant therapies other than apixaban 5mg BID
• Hypersensitivity to any local anesthetic being used by the site
• Pregnant, breastfeeding, or planning to become pregnant
• Use of any hormonal contraceptive methods (e.g., oral, injectable, vaginal ring, transdermal patch, or hormonal intrauterine device [IUD]), or any oral treatment containing estrogen or synthetic estrogen within 30 days prior to Screening or during study participation. Women of childbearing potential must agree to use effective non-hormonal contraception during study participation.
• Participation in another clinical trial for an investigational product within 30 days prior to Screening. In addition, subjects who participated in BXP154-PIL are not eligible for this study.
• Any clinically significant finding on screening assessments or other physical or neurological condition that, in the opinion of the investigator, impairs the ability of the subject to comply with protocol procedures and safely participate in the study