Brickell Biotech Expands Leadership Team, Appointing Dr. Monica Luchi as Chief Medical Officer

Rhea-AI Summary

Brickell Biotech has appointed Dr. Monica Luchi as Chief Medical Officer, bringing over 20 years of experience in drug development.

Dr. Luchi's role will focus on clinical strategy and medical affairs, particularly in the company's pipeline expansion for autoimmune diseases.

CEO Robert Brown emphasized her expertise as critical for accelerating the development of their DYRK1A inhibitor platform and upcoming clinical trials, including the Phase 3 data for sofpironium bromide gel, 15%.

Dr. Luchi previously held significant roles in various biopharmaceutical companies, enhancing Brickell's position in the market.

Positive

• Appointment of Dr. Monica Luchi as Chief Medical Officer expected to enhance clinical strategy.
• Dr. Luchi brings extensive experience in drug development, particularly in autoimmune diseases.
• Acquisition of DYRK1A inhibitor platform opens new clinical development opportunities.
• Upcoming Phase 3 trial for sofpironium bromide gel seen as a significant milestone.

Negative

• None.

Dr. Luchi brings over 20 years of immunotherapeutic and drug development experience and will lead Brickell’s clinical development strategy and medical affairs functions

BOULDER, Colo., Sept. 01, 2021 (GLOBE NEWSWIRE) -- Brickell Biotech, Inc. (“Brickell” or the “Company”) (Nasdaq: BBI), a clinical-stage pharmaceutical company striving to transform patient lives by developing innovative and differentiated prescription therapeutics for the treatment of dermatologic, autoimmune and other debilitating diseases, today announced that it has appointed Monica Luchi, MD, FACR, MBA to the newly created role of Chief Medical Officer. In this new role, Dr. Luchi will oversee the Company’s clinical development strategy and medical affairs functions.

“We are delighted to have Dr. Luchi join our team at this transformative point in our Company’s history. Her tremendous experience developing and executing clinical strategies for novel therapeutics, as well as engaging regulators and the medical community at all stages of development, will be of immeasurable value as we accelerate our pipeline development and expansion,” commented Robert Brown, Chief Executive Officer of Brickell. “The recent acquisition of our novel DYRK1A inhibitor platform, including BBI-02, a Phase 1-ready, highly selective and orally bioavailable DYRK1A inhibitor, is expected to present a number of exciting new clinical development-stage opportunities, and we look forward to working with Dr. Luchi to prioritize, plan and implement these efforts as we broaden our strategic focus into autoimmune and inflammatory diseases.”

“I am thrilled to join a growing company with so many promising near-term milestones on the horizon, including the upcoming Phase 3 topline data release for sofpironium bromide gel, 15%, and a leadership team that has demonstrated an ability to execute its core strategy focused on making fresh tracks in medicine,” commented Dr. Luchi. “With the recent acquisition of our DYRK1A inhibitor platform that was just announced today, I look forward to using my extensive drug development experience spanning across immunology, dermatology and other therapeutic areas to help drive the Company’s product pipeline strategy. I was drawn to Brickell by their mission to develop groundbreaking therapeutics for a wide range of significant diseases and was excited by the opportunity to progress sofpironium bromide gel, 15% towards a potential NDA submission and to explore the role of DYRK1A in autoimmune and neuroinflammatory conditions through the development of a cutting-edge platform that has the potential to pave the way for a new class of therapeutics in these fields.”

Dr. Luchi joins Brickell with over 20 years of experience in the biotech/pharmaceutical industry across all phases of clinical development, strategic planning and business development, with a focus on developing novel therapies for autoimmune diseases. She was most recently working as the interim Chief Medical Officer and a Clinical Development consultant for the Bracken Group. Monica began her career in an academic practice focused on Rheumatology and Immunology before moving to the pharmaceutical industry. She has held positions of increasing responsibility at Novartis, Incyte, Mesoblast, Immune Pharmaceuticals, Celularity, and Sorrento Pharmaceuticals in clinical development, translational medicine, strategic planning, as well as key business development roles. Her experience ranges across all stages of development, from exploratory preclinical through Phase 3, in multiple therapeutic indications, and includes numerous regulatory filings. Dr. Luchi earned a B.A, Biology, Health Sciences Policy from University of Maryland, an M.D. from Northeastern Ohio Universities, College of Medicine, an M.B.A from George Washington University, and an Innovation and Entrepreneurship program certificate from Stanford University. Dr. Luchi is a practicing rheumatologist with an adjunct appointment at the University of Pennsylvania. She also serves on the Board of Trustees for the Children’s Village, NYC.

About Brickell

Brickell Biotech, Inc. is a clinical-stage pharmaceutical company striving to transform patient lives by developing innovative and differentiated prescription therapeutics for the treatment of dermatologic, autoimmune and other debilitating diseases. Brickell’s pipeline combines a potential best-in-class, late clinical-stage program for hyperhidrosis with a novel, cutting-edge platform and development stage candidates with broad potential in autoimmune and neuroinflammatory disorders. Brickell’s executive management team and board of directors bring extensive experience in product development and global commercialization, having served in leadership roles at large global pharmaceutical companies and biotechs that have developed and/or launched successful products, including several that were first-in-class and/or achieved iconic status, such as Cialis^®, Taltz^®, Gemzar®, Prozac^®, Cymbalta® and Juvederm^®. Brickell’s strategy is to leverage this experience to in-license, acquire, develop and commercialize innovative and differentiated pharmaceutical products that Brickell believes can meaningfully benefit patients who are suffering from debilitating diseases that are underserved by available therapies. For more information, visit https://www.brickellbio.com.

Cautionary Note Regarding Forward-Looking Statements

Any statements made in this press release relating to future financial, business and/or research and clinical performance, conditions, plans, prospects, trends, or strategies and other such matters, including without limitation, the anticipated timing, scope, design and/or results of ongoing and future pre-clinical and clinical trials, intellectual property rights, including the validity, term and enforceability of such, the expected timing and/or results of regulatory approvals and size and prospects for commercializing any of Brickell’s product candidates, or research collaborations with its partners, including in Japan, Korea, the United States or any other country, are forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. In addition, when or if used in this press release, the words “may,” “could,” “would,” “should,” “might,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict,” “potential,” “look forward” and similar expressions and their variants, as they relate to Brickell, Kaken, Voronoi, or any of Brickell’s partners, may identify forward-looking statements. Brickell cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time, often quickly and in unanticipated ways. Important factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks and uncertainties, including without limitation, research results and data that do not meet targets or expectations, ability to obtain adequate financing to advance product development, ability to maintain and enforce intellectual property rights, potential delays for any reason in product development and clinical trial enrollment, regulatory changes, supply chain disruptions, unanticipated demands on cash resources, any disruption to its business caused by the current COVID-19 pandemic, interruptions, disruption or inability by Kaken or Voronoi to supply and commercialize research material and/or the product in Japan or Korea as applicable, or obtain or retain adequate pricing or reimbursement, the outcome of Brickell’s ongoing U.S. Phase 3 pivotal program on sofpironium bromide, and other current and planned preclinical and clinical trials, and other risks associated with developing and obtaining regulatory approval for and commercializing product candidates.

Further information on the factors and risks that could cause actual results to differ from any forward-looking statements are contained in Brickell’s filings with the United States Securities and Exchange Commission (SEC), which are available at https://www.sec.gov (or at https://www.brickellbio.com). The forward-looking statements represent the estimates of Brickell as of the date hereof only, and Brickell specifically disclaims any duty or obligation to update forward-looking statements.

Brickell Investor Contact:

Dan Ferry
LifeSci Advisors
(617) 430-7576
daniel@lifesciadvisors.com

FAQ

What are Dr. Monica Luchi's qualifications and experience?

Dr. Luchi has over 20 years of experience in drug development and previously worked as interim CMO for the Bracken Group, holding roles at major pharmaceutical companies.

What will Dr. Luchi's role at Brickell entail?

She will oversee clinical development strategy and medical affairs, focusing on expanding Brickell's pipeline in autoimmune and inflammatory diseases.

What is the significance of the DYRK1A inhibitor platform acquisition?

It presents new clinical development-stage opportunities for Brickell, potentially paving the way for innovative therapeutics.

What is the expected timeline for sofpironium bromide gel's Phase 3 data release?

The Phase 3 topline data release is anticipated soon, marking a critical point in the drug's development.