FibroGen, Inc. (NASDAQ: FGEN) announced the initiation of LELANTOS, a Phase 3, randomized, double-blind, placebo-controlled trial of pamrevlumab or placebo in combination with systemic corticosteroids in patients with non-ambulatory Duchenne muscular dystrophy (DMD).

The primary objective of this global study is to evaluate the effect of pamrevlumab on muscle function in patients with DMD. Approximately 90 patients will be randomized 1:1 to receive pamrevlumab plus systemic corticosteroids, or placebo plus systemic corticosteroids, for up to 52 weeks. The primary efficacy endpoint is the change in the total score of performance of upper limb (PUL) assessment, from baseline to Week 52, and additional endpoints include pulmonary and cardiac function tests. Subjects who complete the 52-week study will be eligible for rollover into an open-label extension study with pamrevlumab and systemic corticosteroids.

“Duchenne muscular dystrophy is a progressive disease associated with muscle deterioration and weakness, often leading to patients becoming wheelchair-bound by the age of 12,” said Elias Kouchakji, M.D., Senior Vice President, Clinical Development, Drug Safety, and Pharmacovigilance, FibroGen. “In DMD, inhibition of connective tissue growth factor (CTGF) by pamrevlumab could result in decreased fibrosis in muscles leading to increased muscle function. We hope pamrevlumab provides a meaningful treatment for the patients with this debilitating disease.” 

Pamrevlumab is a first-in-class antibody developed by FibroGen to inhibit the activity of CTGF, a common factor in fibrotic and proliferative disorders characterized by persistent and excessive scarring that can lead to organ dysfunction and failure. Importantly, skeletal muscle from DMD patients shows elevated levels of CTGF, and a major manifestation of DMD is cardiac fibrosis.

“Initiation of the LELANTOS Phase 3 clinical trial represents a key milestone for FibroGen and for our DMD clinical program, as well as an important development for the patients and families affected by Duchenne,” said Enrique Conterno, Chief Executive Officer, FibroGen. “We are grateful for the collaboration of global regulators, investigators, caregivers, and patients in enabling the conduct of this trial.”

About PamrevlumabPamrevlumab is a first-in-class antibody developed by FibroGen that inhibits the activity of connective tissue growth factor (CTGF), a common factor in fibrotic and proliferative disorders. Pamrevlumab is in Phase 3 clinical development for the treatment of idiopathic pulmonary fibrosis (IPF), locally advanced unresectable pancreatic cancer (LAPC), and Duchenne muscular dystrophy (DMD); and in Phase 2 clinical development for coronavirus (COVID-19). For information about pamrevlumab studies currently recruiting patients, please visit www.clinicaltrials.gov.

About Duchenne Muscular DystrophyDuchenne muscular dystrophy is a rare and debilitating neuromuscular disease that affects approximately 1 in every 3,500 newborn boys. The fatal disease is caused by a genetic mutation leading to the absence or defect of dystrophin, a protein necessary for normal muscle function. The absence of dystrophin results in muscle weakness, muscle loss, fibrosis, and inflammation. Patients with DMD are often wheelchair-bound before the age of 12, and their progressive muscle weakness may lead to serious medical problems relating to respiratory and cardiac muscle.

About FibroGenFibroGen, Inc. is a biopharmaceutical company committed to discovering, developing and commercializing a pipeline of first-in-class therapeutics. The company applies its pioneering expertise in hypoxia-inducible factor (HIF) and connective tissue growth factor (CTGF) biology to advance innovative medicines to treat unmet needs. The Company is currently developing and commercializing roxadustat, an oral small molecule inhibitor of HIF prolyl hydroxylase activity, for anemia associated with chronic kidney disease (CKD). Roxadustat is also in clinical development for anemia associated with myelodysplastic syndromes (MDS) and for chemotherapy-induced anemia. Pamrevlumab, an anti-CTGF human monoclonal antibody, is in clinical development for the treatment of idiopathic pulmonary fibrosis (IPF), locally advanced unresectable pancreatic cancer (LAPC), Duchenne muscular dystrophy (DMD), and coronavirus (COVID-19). For more information, please visit www.fibrogen.com.

Forward-Looking StatementsThis release contains forward-looking statements regarding our strategy, future plans and prospects, including statements regarding the development and commercialization of the company’s product candidates, the potential safety and efficacy profile of our product candidates, our clinical programs and regulatory events, and those of our partners. These forward-looking statements include, but are not limited to, statements about our plans, objectives, representations and contentions and are not historical facts and typically are identified by use of terms such as “may,” “will”, “should,” “on track,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. Our actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties related to the continued progress and timing of our various programs, including the enrollment and results from ongoing and potential future clinical trials, and other matters that are described in our Annual Report on Form 10-K for the fiscal year ended December 31, 2019, and our Quarterly Report on Form 10-Q for quarter ended March 31, 2020, filed with the Securities and Exchange Commission (SEC), including the risk factors set forth therein. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and we undertake no obligation to update any forward-looking statement in this press release, except as required by law.

Contact:FibroGen, Inc.

Media Inquiries:Sara Iacovino1.703.474.4452sara.iacovino@gcihealth.com

Investors:Michael Tung, M.D.Corporate Strategy / Investor Relations 1.415.630.0131mtung@fibrogen.com

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