MINNEAPOLIS, MN— August 6, 2019 — SilkTech Biopharmaceuticals, a biotechnology company focused on the development of novel therapies to treat Dry Eye Disease (DED), today announced the completion of their Phase 2B clinical trial enrollment to assess the safety and efficacy of the company’s SDP-4 ophthalmic eye-drop formulation to treat the signs and symptoms of DED. This is the first-in-human study for the biological drug candidate.
The Phase 2B study is a randomized, double masked, vehicle-controlled, multi-center, 3-month trial designed to evaluate the safety and efficacy of topical application of the SDP-4 ophthalmic formulation at 0.1%, 1%, and 3% concentrations dosed twice per day on patients with moderate to severe DED. The trial enrolled 305 patients and is being conducted at 25 sites across the U.S. The company expects to report top-line data by the end of Q4 of 2019.
“Our team has accomplished a significant milestone in reaching full enrollment of our first-in-human ophthalmic study for a silk protein derived biotherapeutic,” says Brian Lawrence, Ph.D., the CEO of SilkTech. “The trial enrolled 6 weeks ahead of projected schedule indicating the significant and growing need for new therapeutic approaches to this debilitating disease.”
“The SDP-4 ophthalmic formulation provides an innovative protein-based approach to addressing the signs and symptoms of Dry Eye,” said Eric Donnenfeld, M.D., Founding Partner of Ophthalmic Consultants of Connecticut. “The proposed use of the SDP-4 protein to provide a dual mechanism of action that both enhances wetting and spreading on the eye to stabilize the tear film, while also reducing inflammation offers a highly novel approach unlike other technologies either on the market or in development today.”
SDP-4 is a novel biotherapeutic naturally derived from silk protein, and is designed to treat DED through a dual-mechanism of action to physically improve tear film stability and in addition reduce inflammation. SDP-4’s inherent protein nature enhances spreading and wetting properties of aqueous formulations on hydrophobic surfaces, and it behaves similar to mucin proteins which are responsible for the spreading and wetting properties of natural tears on the hydrophobic ocular surface to stabilize the tear film. Additionally, SDP-4 is designed to inhibit kinase activation of the NF-κB gene transcription pathway, which is a cellular signaling pathway that is known to play a role in the production of pro-inflammatory mediators of DED.
Up to 340 million people suffer from Dry Eye Disease (DED) worldwide. In the U.S., nearly 16 million patients are estimated to have been diagnosed with DED. An additional 30 to 40 million individuals may remain undiagnosed and could benefit from therapeutic treatment. DED is a disorder of the tear film that can lead to ocular surface damage and create discomfort for the patient. When compromised, the tear film may leave portions of the ocular surface uncovered, or cause tears to become unhealthy in composition. The compromise of the tear film is multifactorial which may be environmental or physiological in nature and leads to significant irritation for patients. Continued irritation to the ocular surface may exacerbate the inflammation over time, further destabilizing the tear film and potentially worsening patient symptoms. SDP-4 is designed to counteract these effects by working to simultaneously stabilize the tear film with protein, while inhibiting inflammation that may cause DED symptoms.
About SilkTech Biopharmaceuticals
SilkTech Biopharmaceuticals, founded in 2013 and based in Plymouth, a suburb of Minneapolis MN, is a privately held corporation that is a leading developer of silk-based biotherapeutic technologies. The company is devoted to transforming the treatment of DED through the use of its patented silk-derived protein (SDP) technology, which is produced from the naturally occurring Bombyx mori silkworm cocoon. Please visit http://www.silk-tech.com for the latest information and company development updates.
IMPORTANT NOTICE: SDP-4 is an investigational new drug. SDP-4 has not been approved by the US Food and Drug Administration (FDA) for safety or effectiveness. The FDA has not approved SDP-4 for use. No clinical testing results have shown that SDP-4 is safe or effective.