공시 • Apr 10
Cloudbreak Pharma Inc Provides Pipeline Updates
Cloudbreak Pharma Inc., Cloudbreak’s lead asset, the eye drop CBT-001, is in mid-Phase 3 as a potential treatment for pterygium, a potentially sight-threatening disease that impacts 15 million people in the U.S. alone. The company’s second asset, the eye drop CBT-004, is entering Phase 3 as a potential disease modifying treatment for pinguecula, which is estimated to impact half of people over the age of 70, or 50 million people in the U.S. alone. Cloudbreak is also advancing a broad pipeline of additional high-value technologies with pre-clinical through Phase 3-ready product candidates. Lead candidate, CBT-001 for the treatment of pterygium, a multi-billion-dollar addressable market, is in mid-Phase 3 with initial topline data anticipated in Third Quarter 2026. Second asset, CBT-004 for the treatment of pinguecula, is Phase 3-ready following a successful End-of-Phase-2 meeting with FDA and alignment on a path forward. Pterygium is a triangular fibrovascular growth on the cornea, connected to the conjunctiva. It is commonly caused by excessive UV exposure and can lead to redness, irritation, foreign body sensation, and, with continued progression, potentially serious vision problems. The company estimates that pterygium impacts as many as 15 million people in the U.S. alone. Of those, approximately 7.5 million are seen annually by an eye doctor, and 3.7 million are formally diagnosed each year by an ophthalmologist or medical optometrist. There are currently no FDA-approved disease-modifying treatments for pterygium. Most patients are treated for their symptoms using artificial tears, prescription dry eye products and/or off-label NSAIDs or corticosteroids, with limited success for long-term use. For more severe cases, approximately 100,000 patients annually elect to have surgery, at a cost of $11,500 per procedure, and recurrence rates are estimated to be as high as 38%. Pinguecula (pin·gwek·yoo·luh) is a round, yellowish, elevated tissue that develops on the surface of the eye. The condition is very common among people with increased UV light exposure and increasing age. The condition impacts over a billion people worldwide, including 50 million people in the US alone. Of those, 15 million are seen annually by an eye doctor, and 3.9 million are formally diagnosed each year by an ophthalmologist or medical optometrist. When the tissue becomes vascularized or inflamed, it can produce a number of symptoms including ocular redness, discomfort and pain, foreign body sensation and tearing and itching. Depending on the location and size of the pinguecula, it may also make wearing contact lenses uncomfortable or impossible. There are currently no FDA-approved pharmacological treatments for pinguecula. To treat some symptoms, such as dry eye and foreign body sensation, lubricating eye drops may be used. For pinguecula that are larger or inflamed, non-steroidal anti-inflammatory drugs or corticosteroids are used, although the former can be associated with corneal complications, while the latter is associated with glaucoma and cataract formation. CBT-001 is a novel, multi-kinase inhibitor (MKI) eye drop being developed for the treatment of pterygium, a common ocular surface disease with no FDA-approved drug therapies. Currently in mid-Phase 3 clinical trials across multiple regions, CBT-001 is designed to target the underlying fibrovascular and angiogenic drivers of the disease rather than just providing symptomatic relief. In earlier studies, the therapy demonstrated meaningful reductions in lesion growth, vascularity, and ocular redness, with a favorable safety profile. If approved, CBT-001 has the potential to become the first pharmacologic treatment for pterygium, potentially delaying or eliminating the need for surgery and addressing a significant unmet medical need. CBT-004 is a novel, preservative-free topical ophthalmic solution containing a potent VEGF receptor inhibitor. CBT-004 also inhibits platelet-derived growth factors which are responsible for blood vessel maintenance. By inhibiting these growth factors and modifying the disease, the formulation is specifically designed to address the hyperemia and abnormal vascularization associated with the pinguecula lesion. The preservative-free formulation is designed to minimize potential ocular surface toxicity, positioning it for possible chronic use in this condition affecting the delicate ocular surface. Under the MKI platform, Cloudbreak’s lead asset, the eye drop CBT-001, is in mid-Phase 3 in multiple regions for the treatment of pterygium, a disease impacting 15 million people in the US alone. Its second asset, CBT-004, is entering Phase 3 for pinguecula, a disease impacting about half of all people over age 70. CBT-001 and CBT-004 will potentially be the first and only FDA-approved drug therapies for these high-value conditions. The Company has additional technologies with pre-clinical through Phase 2 product candidates.