Program

Obstructive Sleep Apnea

IHL-42X

Hopeful male patient meeting with a doctor

Overview

IHL-42X is an oral fixed-dose combination therapy of acetazolamide and dronabinol currently in clinical studies for the treatment obstructive sleep apnea (OSA).

In a Phase 2 clinical trial, IHL-42X was shown to reduce the Apnea-Hypopnea Index (AHI) in all dosage strengths tested. AHI is a key measurement used to assess the severity of OSA by quantifying the number of apneas (complete stoppages of breathing) and hypopneas (partial blockages of breathing) that occur per hour of sleep. In this trial, the lowest dose of IHL-42X was observed to be the most effective, reducing AHI by an average of 51 percent relative to baseline, where 25 percent of patients experienced a reduction in AHI of greater than 80 percent.

We are currently conducting a global Phase 2/3 efficacy and safety trial (RePOSA) to evaluate the effect of IHL-42X in individuals with OSA who are either non-compliant, intolerant, or naïve to positive airway pressure devices, including CPAP.

img

Details

IHL-42X combines two active pharmaceutical ingredients that are each known to reduce AHI when administered individually, acetazolamide and dronabinol. Acetazolamide is a carbonic anhydrase inhibitor approved for various indications. Dronabinol is a synthetic form of delta-9-tetrahydrocannabinol (THC) approved for the treatment of nausea and vomiting in chemotherapy, and anorexia associated with immunodeficiency syndrome. In OSA, dronabinol targets and binds to cannabinoid receptors, stimulating airway dilation, while acetazolamide induces modest metabolic acidosis, signaling excess CO2 in the blood, thus increasing respiration. By combining two agents with mechanisms known to reduce AHI in one pharmaceutical formulation, we believe IHL-42X may have therapeutic benefits at lower doses of each constituent drug that are safe and tolerable.

OSA is a sleep-disordered breathing condition characterized by the narrowing or collapse of the upper airway during sleep, which disrupts breathing and results in poor quality of sleep. Presentation of OSA often includes snoring and episodes of waking up gasping for air. Despite being recognized as a common and chronic disorder, OSA remains under-diagnosed and inadequately treated.

swipe
img

IHL-42X

Obstructive Sleep Apnea

  • RePOSA

    Ph 2/3 Safety & Efficacy Trial
    • 560-patient, randomized, double-blind safety and efficacy study
    • Dosing started May 2024
  • BA/BE

    Bioavailability Trial
    • 115-subject, bioavailability and bioequivalence study
    • Dosing completed July 2024
  • POC

    Ph 2 Trial
    • Crossover, safety and efficacy study
    • Study completed

Market Details

The global market for sleep apnea treatment is significant and growing, driven by increasing awareness and the rising prevalence of sleep disorders.

The global market for sleep apnea devices was valued at $8.2 billion in 2023 and is expected to grow to $20.4 billion by 2033.

Get in touch to learn more about our programs and to receive updates.

Contact Us img