Dompé announces the enrollment of the first patient in the phase 3 trial of cenegermin in patients with severe dry eye disease related to Sjögren’s disease

– Two multicenter Phase 3 clinical trials will evaluate the safety and efficacy of cenegermin in patients with severe dry eye disease related to Sjögren’s disease

– The Eye Research Foundation in Newport Beach, California is one of more than 10 clinical trial sites in the United States and Europe

– Dompé partners with the Sjögren Foundation to improve understanding of the disease and provide information on opportunities to participate in clinical research.

Milan, Italy and SAN MATEO, California, February 9, 2022 /PRNewswire/ — Dompé farmaceutici SpA and Dompé US Inc. (collectively Dompé) announced today that the first patient has been enrolled in its Phase 3 clinical trial to evaluate the efficacy and safety of cenegermine in patients with severe Sjögren’s dry eye, a primary symptom of Sjögren’s disease, which is often underdiagnosed1. This trial is part of a program that includes two randomized, double-blind, vehicle-controlled studies that will be conducted at more than 10 sites in the United States and Europe, 2.3 and was initiated following encouraging data from a phase 2 study, the results of which will be shared at an upcoming medical meeting. This study evaluated the efficacy and safety of cenegermin ophthalmic solution versus vehicle in patients with moderate to severe dry eye disease, including a subset of patients diagnosed with Sjögren’s disease without associated rheumatic disease. . 8

(PRNewsfoto/Dompé Farmaceutici SpA)

Sjögren’s disease (pronounced SHOW-grins) is an autoimmune disease that can affect many parts of the body. In patients who are affected, the body’s white blood cells attack certain glands, including those that provide lubrication to our eyes and mouth. Therefore, dry eye is common in people living with Sjögren’s disease.1. Dry eyes associated with Sjögren’s disease can lead to vision problems including light sensitivity, blurred vision and corneal damage4.

“The majority of Sjögren’s patients live with dry eye, and many of these patients will experience eye symptoms which can often be quite severe,” said Jeannet church, CEO of the Sjögren Foundation. “We are grateful for Dompé’s commitment to research that may lead to new treatment options for people with Sjögren’s disease who suffer from dry eye disease and we encourage people to speak to their doctor to learn more. on participation in clinical trials.

There are currently no FDA-approved treatments for Sjögren’s severe dry eye disease; it is managed by replacing moisture at the affected glandular sites and suppressing the autoimmune response locally as well as systemically1.

“With cenegermin, Dompé has led the way, leveraging decades of research to better understand how nerve growth factor (NGF) contributes to overall eye health.” noted Melissa Toyos, MD, Principal Investigator and Partner and Director of Research at Toyos Clinic. “Studies have demonstrated a neurosensory component in certain types of dry eye, suggesting that cenegermin could be an innovative option for these patients.” 9

The NGF0121 study (NCT 05133180) will enroll 100 patients and will use the Schirmer test and Symptom Assessment Questionnaire in Dry Eye (SANDE) as primary endpoints to measure improvement in signs and symptoms of dry eye over time.2. The NGF0221 study (NCT 05136170) will enroll 48 patients who are currently being treated for severe Sjögren-related dry eye with cyclosporine A3 and will use Schirmer’s test as the sole primary endpoint3. Patients in both studies will be randomized (1:1) to receive either cenegermin ophthalmic solution 20 mcg/mL or vehicle three times daily. 2.3.

“These studies illustrate our commitment to exploring how NGF science can innovate for eye diseases with unmet medical need.” noted Ashley KlinGlobal Head of Biotechnology, Dompé Farmaceutici SpA and Managing Director, Dompé US Inc. lasting effect impact on ocular tissue and help restore the natural homeostasis of the eye.” ten

For more information or a list of sites for ongoing clinical trials evaluating the safety and efficacy of cenegermin in patients with severe Sjögren’s dry eye, contact [email protected] or visit www.clinicaltrials .gov.

About Oxervate® (cenegermin-bkbj ophthalmic solution)

Oxervate is a 0.002% cenegermin-bkbj (20 mcg/mL) topical solution currently approved by the FDA for the rare disease neurotrophic keratitis (NK). Its active ingredient cenegermin-bkbj, is a recombinant form of human nerve growth factor and is structurally identical to the NGF protein made naturally by the body5, 6. Nerve growth factor (NGF) is involved in the differentiation and maintenance of neurons which acts through specific high and low affinity receptors in the anterior segment of the eye to support the innervation and integrity of the cornea.seven

Oxervate is not yet FDA approved for the treatment of severe dry eye disease related to Sjögren’s disease. More information about Oxervate for Neurotrophic Keratitis can be found in the full product prescribing information: www.oxervate.com

Important Safety Information

Contact lenses should be removed prior to application of OXERVATE as the presence of a contact lens (therapeutic or corrective) could theoretically limit the delivery of cenegermin-bkbj to the area of ​​corneal injury. The lenses can be reinserted 15 minutes after administration.

OXERVATE may cause mild to moderate eye discomfort such as eye pain during treatment. The patient should be advised to contact their physician in the event of a more serious eye reaction.

The most common adverse reaction in clinical trials that occurred more frequently with OXERVATE was eye pain (16% of patients). Adverse effects included corneal deposits, foreign body sensations in the eye, ocular hyperemia (enlargement of blood vessels in the whites of the eyes), swelling (inflammation) of the eye, and increased tearing (1 in 10% of patients). seven

Domped in Ophthalmology

Dompé farmaceutici SpA is a rapidly growing privately-held global biopharmaceutical company founded in Milan, Italy, with a 130-year legacy of medical innovation. For more than a decade, Dompé has been a leader in the research and development of innovative therapies based on neurotrophins, proteins derived from the Nerve Growth Factor (NGF). The company’s expertise in NGF began in ophthalmology and led to a breakthrough designation following FDA approval of Oxervate® for the rare disease, neurotrophic keratitis (NK). Ongoing research in ophthalmology includes post-marketing research on NK, studies on Sjögren’s severe dry eye, and other undisclosed programs. Dompé’s R&D is anchored in EXSCALATE, an in-house developed framework-based virtual scouting platform that leverages one of the world’s most powerful supercomputing and artificial intelligence platforms. Dompé employs more than 800 employees worldwide and maintains a business operations center in the United States in the San Francisco Bay Area as well as an R&D presence in Boston.

Forward-looking statements

This press release refers to certain information that may not coincide with expected future results. Dompé firmly believes in the soundness and reasonableness of the concepts expressed. However, certain information is subject to a certain degree of indeterminacy in relation to its research and development activities and the necessary checks to be carried out by regulatory bodies. Consequently, to date, Dompé cannot guarantee that the expected results will be consistent with the information provided above.

The references

1. Carsons SE, Patel BC. Sjogren’s syndrome. [Updated 2021 Aug 9]. In: StatPearls [Internet]. treasure island (FL): StatPearls Publishing; 2021 Jan-. Available at: https://www.ncbi.nlm.nih.gov/books/NBK431049/.

2. ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (USA). Identifier NCT05133180, Study to Evaluate the Safety and Efficacy of Oxervate® Ophthalmic Solution versus Vehicle in Sjögren’s Severe Dry Eye Disease (NGF0121); Updated on January 18, 2022 [accessed 2022 Jan 26]; [about 10 screens]. Available at: https://clinicaltrials.gov/ct2/show/NCT05133180?term=rhNGF&cond=dry+eye&draw=2&rank=5

3. ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (USA). Identifier NCT05136170, study to evaluate the safety and efficacy of Cenegermin (Oxervate®) 20 mcg/mL versus vehicle, in patients with Sjögren’s dry eye disease (NGF0221); Updated on January 18, 2022 [accessed 2022 Jan 26]; [about 10 screens]. Available at: https://clinicaltrials.gov/ct2/show/NCT05136170?term=rhNGF&cond=dry+eye&draw=2&rank=4

4. Kassan SS, Moutsopoulos HM. Clinical manifestations and early diagnosis of Sjögren’s syndrome. Arch Med Intern. 2004 Jun 28;164(12):1275-84. doi: 10.1001/archite.164.12.1275. PMID: 15226160.

5. Dompé Farmaceutici SpA (October 2019). OXERVATE™ (cenegermin-bkbj) ophthalmic solution 0.002% (20 mcg/mL): Prescribing Information Highlights. Retrieved from https://oxervate.com/wp-content/uploads/2020/05/OXERVATE_Prescribe_Information_102019.pdf [Accessed 2022 Jan 26]

6. Lambiase A, Rama P, Bonini S, Caprioglio G, Aloe L. Topical treatment with nerve growth factor for corneal neurotrophic ulcers. N Engl J Med 1998;338:1174-80.

7. OXERVATE.com. 2019. Important Safety Information – OXERVATE™ (cenegermin-bkbj) ophthalmic solution 0.002% (20 mcg/mL) HPC. [online] Available on : [Accessed 2022 Jan 26].

8. Archived Data. NGF0118

9. Villani E, Galimberti D, Viola F, Mapelli C, Ratiglia R. The cornea in Sjogren’s syndrome: an in vivo confocal study. Invest Ophthalmol Vis Sci. 2007 May;48(5):2017-22. doi: 10.1167/iovs.06-1129. PMID: 17460255.

10. Zhang X, M VJ, Qu Y et al. Managing dry eye: targeting the ocular surface microenvironment. Int J Mol Sci. 2017;18(7):1398. Published June 29, 2017. doi:10.3390/ijms18071398

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