"In my experience, a considerable number of severe keratitis patients can have persistent disease that may not be resolved by first-line treatment," said Eugene McLaurin, MD and Fellow, American Academy of Ophthalmology and American College of Surgeons. "I am pleased that the first patient has been enrolled in this important Phase 4 study, the results of which may potentially provide data to further support Acthar Gel as a treatment option in appropriate keratitis patients."
Acthar Gel is approved by the U.S. Food and Drug Administration (FDA) for the treatment of severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa - such as keratitis, iritis, iridocyclitis, diffuse posterior uveitis and choroiditis, optic neuritis, chorioretinitis, anterior segment inflammation - one of the product's 19 indications. Please see Important Safety Information below.
"The enrollment of the first patient in this study is an important milestone in our assessment of Acthar's efficacy as a treatment option for patients with keratitis," said Tunde Otulana, M.D., Chief Medical Officer at Mallinckrodt. "We believe this exploratory evaluation of patients whose severe keratitis persists - after the use of one or more standard treatments - can potentially help physicians better understand which individuals may benefit from the drug as a treatment alternative."
About the Trial
The Phase 4 clinical study is titled "A Multicenter, Open-Label Study to Assess the Efficacy and Safety of Acthar Gel in Subjects with Severe Keratitis." This is a Phase 4, multicenter, multiple dose, open label study to examine the effects of Acthar in adult subjects, with a target enrollment of 30. Subjects with current severe keratitis who meet entry criteria will be treated with Acthar Gel 1 mL (80 units [U]) subcutaneously (SC) two times per week for 12 weeks. Initial treatment will be followed by a taper to Acthar 1 mL (80 U) SC once a week for two weeks, then 0.5 mL (40 U) SC once a week for two weeks1.
Response will be evaluated by determining the proportion of patients who improved on the Impact of Dry Eye on Everyday Life scale (time frame: from baseline to 12 weeks) and the proportion of subjects who show improvement from baseline in the IDEEL symptom bother score at 12 weeks1.
Full study details can be found on clinicaltrials.gov.
About Severe Keratitis
Keratitis is a painful inflammation of the cornea which can result in partial or total loss of vision if left untreated and is a significant cause of ocular morbidity around the world.2 It can result from infectious agents (e.g., microbes including bacteria, fungi, amebae, and viruses) or from noninfectious causes (e.g., eye trauma, chemical exposure, and ultraviolet exposure).3 Conditions that affect the integrity of the ocular surface epithelium (exposure keratitis, neurotrophic keratitis, keratomalacia, recurrent corneal erosions) may also lead to development of sterile corneal ulcers.4 Non-infectious corneal ulcers may be associated with various collagen vascular or other autoimmune diseases, sometimes as the presenting sign of the disease.3
About Acthar Gel (repository corticotropin injection) Indications
Acthar Gel is an injectable drug approved by the FDA for the treatment of 19 indications. Of these, today the majority of Acthar use is in these indications:
IMPORTANT SAFETY INFORMATION
Warnings and Precautions
Other adverse events reported are included in the full Prescribing Information.
Please see full Prescribing Information.
Mallinckrodt is a global business consisting of multiple wholly owned subsidiaries that develop, manufacture, market and distribute specialty pharmaceutical products and therapies. The company's Specialty Brands reportable segment's areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, nephrology, pulmonology and ophthalmology; immunotherapy and neonatal respiratory critical care therapies; analgesics and gastrointestinal products. Its Specialty Generics reportable segment includes specialty generic drugs and active pharmaceutical ingredients. To learn more about Mallinckrodt, visit www.mallinckrodt.com.
Mallinckrodt uses its website as a channel of distribution of important company information, such as press releases, investor presentations and other financial information. It also uses its website to expedite public access to time-critical information regarding the company in advance of or in lieu of distributing a press release or a filing with the U.S. Securities and Exchange Commission (SEC) disclosing the same information. Therefore, investors should look to the Investor Relations page of the website for important and time-critical information. Visitors to the website can also register to receive automatic e-mail and other notifications alerting them when new information is made available on the Investor Relations page of the website.
CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS
This release includes forward-looking statements concerning Acthar Gel including expectations with regard to the study described in this release, as well as its potential impact on patients and anticipated benefits associated with its use. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; issues with product quality, manufacturing or supply, or patient safety issues; and other risks identified and described in more detail in the "Risk Factors" section of Mallinckrodt's most recent Annual Report on Form 10-K and other filings with the SEC, all of which are available on its website. The forward-looking statements made herein speak only as of the date hereof and Mallinckrodt does not assume any obligation to update or revise any forward-looking statement, whether as a result of new information, future events and developments or otherwise, except as required by law.
Daniel J. Speciale, CPA
Investor Relations and Strategy Officer
Mallinckrodt, the "M" brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. Other brands are trademarks of a Mallinckrodt company or their respective owners. © 2019 Mallinckrodt. US-1902249 12/19
2 Sharma S. Keratitis. Bioscience Reports. 2001;21:419-444.
3 Collier SA, Gronostaj MP, MacGurn, AK, Cope JR, Awsumb KL, Yoder JS, et al. Estimated burden of keratitis--United States, 2010. MMWR Morb Mortal Wkly Rep. 2014;63(45):1027-1030..
4 Donzis PB, Mondino BJ. Management of noninfectious corneal ulcers. Surv Ophthalmol. 1987;32:94-110.
SOURCE Mallinckrodt plc
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