WHY US

Business Wire India is the only Indian news distribution platform to partner with ANI, PTI, IANS, and UNI Testimonials - Whenever we have something important to tell, Business Wire India is often our first point of call, Rajnish Wahi, Senior VP, Corporate Affairs & Communication, Snapdeal. I define Business Wire India as a facilitator for the communications industry, Sudeshna Das, Executive Director, ComConnect. Business Wire India is very good in terms of credible and authentic news distribution to media. It adds authenticity to all content, Arneeta Vasudeva, Vice President, Ogilvy. Business Wire India is the only Indian news distribution platform to partner with ANI, PTI, IANS, and UNI The BW India team is very professional and prompt, we have been working seamlessly with BW for many years now, Prathibha Nair, Assistant Manager - Corporate Communications, Wipro Limited. Businesswire helps us in securing coverage on prominent media outlets across US, Europe and India and the detailed tracking reports allow us to monitor our press release. All members of the servicing team are cooperative and efficient and they truly augment our outreach efforts, Aniruddha Basu, PR & Corporate Communications, L&T Technology Services

(BW)(GALDERMA)

Galderma Advances Phase 3 Clinical Study with Nemolizumab in Moderate-to-Severe Atopic Dermatitis

  • Thursday, October 10, 2019 2:15PM IST (8:45AM GMT)
 
Lausanne, Switzerland:  

Galderma, a global leader focused on meeting the world's increasing skin health needs, announced that it has enrolled the first patients in a new Phase 3 clinical study with nemolizumab, an investigational therapy in adult patients with moderate-to-severe atopic dermatitis.

 

This study is a randomized, double-blinded, placebo-controlled study to assess the efficacy and safety of nemolizumab in subjects with moderate-to-severe atopic dermatitis.

 

Nemolizumab is a first-in-class investigational monoclonal antibody that blocks signaling of IL-31, a cytokine that plays a key role in the pathogenesis of moderate-to-severe atopic dermatitis. Atopic dermatitis is a serious, chronic form of eczema associated with a high burden of disease linked to itch, sleep deprivation and significant quality of life impairment.

 

“We are advancing the development of nemolizumab as planned. The Phase 2 results showed clear clinical benefits, adding to the growing scientific evidence that the IL-31 pathway may be an important driver in atopic dermatitis. We are committed to continuing our work to bring new therapies to patients with moderate-to-severe atopic dermatitis,” said Thibaud Portal PhD, Galderma Global Vice President, Prescription medicines.

 

Earlier this year, Galderma presented the final results from the Phase 2b study of nemolizumab in patients with moderate-to-severe atopic dermatitis at the 2019 American Academy of Dermatology Annual Meeting late-breaking session and published in the Journal of Allergy and Clinical Immunology in August 20191

 

About the IL-31 Pathway and Atopic Dermatitis

 

Moderate-to-severe atopic dermatitis (AD), a serious, chronic form of eczema, is a systemic inflammatory disease characterized by an allergic response driven by a subset of immune cells called Type 2 helper T cells, or Th2 cells. IL-31, a cytokine released by Th2 cells, is involved in AD associated pruritus by interacting with IL-31 receptor alpha expressed by neuron. IL-31 is also thought to play a role in AD skin inflammation and AD skin barrier impairment. Moderate-to-severe forms of AD can be characterized by pronounced cutaneous dryness, and skin lesions marked by redness, infiltration/papulation, crusting/oozing, and lichenification, with periods of lesion exacerbation accompanied by intense itching, scratching, and skin damage that can lead to secondary infections. Moderate-to-severe AD can negatively impact patients’ lives and is associated with a high burden to patients particularly with itching, sleep deprivation and depression.

 

About Nemolizumab

 

Nemolizumab, a first-in-class humanized monoclonal antibody, is directed against the IL-31R alpha, which blocks signaling from - IL-31. Nemolizumab, initially developed by Chugai Pharmaceutical Co., Ltd., was subsequently licensed to Galderma in 2016. Nemolizumab is an investigational agent under clinical development and its safety and efficacy have not been fully evaluated by any regulatory authority.

 

About Galderma

 

Galderma, the world's largest independent global dermatology company, was created in 1981 and is now present in over 100 countries with an extensive product portfolio to treat a range of dermatological conditions. The company partners with health care practitioners around the world to meet the skin health needs of people throughout their lifetime. Galderma is a leader in research and development of scientifically-defined and medically-proven solutions for the skin. For more information, please visit www.galderma.com

 

References

 

1. Silverberg JI, et al., Phase 2b Randomized Study of Nemolizumab in Adults with Moderate-Severe Atopic Dermatitis and Severe Pruritus, Journal of Allergy and Clinical Immunology 2019, doi: https://doi.org/10.1016/j.jaci.2019.08.013.

 

 


Click here for Media Contact Details
CONTACTS :

Media
Sébastien Cros, Head of Corporate Communications, media@galderma.com

Submit your press release

Copyright © 2019 Business Wire India. All Rights Reserved.