Creabilis Receives Positive Feedback on CT327 from US FDA, Providing Clear Path to Registration

- Positive feedback in line with successful outcome meetings with MHRA and MEB
- Global Phase III development program being prepared following clear regulatory guidance

Canterbury, UK I January 12, 2015 I Creabilis Ltd, the dermatology company with the most advanced targeted topical treatment in development for chronic pruritus (itch), announces that it has received positive feedback from the US Food and Drug Administration (FDA) on its lead product CT327. Creabilis will now make the final preparations to advance CT327, its novel topical targeted treatment for peripheral pruritus into a pivotal Phase III development program to address pruritus due to psoriasis.

In the meeting the FDA examined the positive data already reported with the Company’s lead product CT327, a first-in-class TrkA kinase inhibitor for the treatment of pruritus (itch) of psoriasis. In the FDA’s meeting minutes, the importance of pruritus due to psoriasis was acknowledged as an indication in its own right due to the fact that no treatment is currently labelled for this common condition. This outcome is in line with successful meetings already held with the MHRA and MEB and Creabilis believes defines the clearest route to registration.

Creabilis is now preparing to initiate its Phase III development program for CT327 and has already initiated partnering discussions for this unique treatment.

About Pruritus

Chronic pruritus (itch) is a debilitating symptom of many dermatological diseases and has a significant impact on quality of life. Patients with chronic pruritus often have multiple episodes per day, scratch until bleeding, and are unable to sleep, resulting in broader socioeconomic and psychosocial problems for these patients, including impacts on school, work attendance, and depression. Pruritus is one of the most important symptoms of psoriasis. There is no medicine currently approved for the topical treatment of chronic pruritus. A recent study found no existing treatment relieved pruritus in 45% of psoriatics.

About Pruritus and CT327

CT327 inhibits the intracellular kinase of the TrkA receptor, the high affinity receptor for Nerve Growth Factor (NGF), and consequently reduces the peripheral sensitisation of sensory neurons, a process that plays a pivotal role in the pathogenesis of pruritus.

About the Phase IIb Trial in Pruritus of Psoriasis

In a Phase IIb study of 160 subjects designed to evaluate the safety and efficacy of CT327, patients receiving CT327 showed a statistically significant and clinically meaningful reduction in pruritus compared to blinded vehicle emollient. Pruritus was measured using a visual analogue scale (VAS). The improvement from baseline in pruritus VAS reached 60% for patients treated with CT327 compared to 20% for patients treated with vehicle (p<0.05). Up to 62% of patients treated with CT327 achieved at least a 50% reduction in pruritus VAS compared to 32% of patients on vehicle (p<0.05). At baseline, 69% of CT327 treated patients had none or mild pruritus by end of therapy (VAS > 40mm). CT327 was safe and well tolerated, with no application site reactions.

About Creabilis

Creabilis is a dermatology company with the most advanced targeted topical treatment in development for chronic peripheral pruritus (itch). Creabilis has delivered positive Phase 2b results for CT327 in the treatment of pruritus in psoriasis patients. CT327 was developed using Creabilis' proprietary Low Systemic Exposure (LSE) 'topical-by-design' technology that creates molecules optimized for topical applications. Planning for Phase 3 trials with CT327 are underway, with a clear route to the peripheral pruritus market via the initial indication of pruritus due to psoriasis. Creabilis' pipeline also includes CT340, an IND-ready and potent narrow spectrum kinase inhibitor in development for the topical treatment of chronic pain.

Creabilis is backed by highly respected life science investors Sofinnova Partners, Neomed and AbbVie Biotech Ventures Inc., and is led by an experienced Management team. Creabilis' Corporate Headquarters and Development functions are based in the UK, with Research activities in Italy.

SOURCE: Creabilis

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