Silk Protein for Your Eyes?

SilkTech Biopharmaceuticals uses the natural therapeutic properties of proteins derived from silk cocoons to produce an innovative drug product designed to treat the signs and symptoms of Dry Eye Disease (DED).
How It Works


Silk Protein for Your Eyes?
SilkTech is a clinical stage biopharmaceutical company that utilizes the natural therapeutic properties of silk-derived proteins to produce an innovative biologic drug product designed to treat the signs and symptoms of Dry Eye Disease (DED). Worldwide it is estimated that over 340MM people suffer from DED, in the US 15 million are currently diagnosed, while 40 million are undiagnosed, and represents a significant treatment challenge to clinicians.
How It Works
THE PRODUCT - SILK-DERIVED PROTEIN-4 (SDP-4)

SDP-4 offers a unique therapeutic approach that uses a naturally derived silk protein to treat Dry Eye Disease (DED). The SDP-4 drug candidate has been designed to inhibit inflammation that creates DED symptoms while simultaneously improving the spreading and wetting properties of the eye drop on the ocular surface to improve patient comfort.

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DED IS A SIGNIFICANT PROBLEM BOTH IN THE US AND WORLDWIDE

It is estimated that up to 340 million people suffer from Dry Eye Disease (DED) worldwide, with 45 - 60 million people in the US alone. Estimates show that nearly 16 million patients are diagnosed with DED in the US [1], and further studies suggest up to an additional 30 – 40 million individuals may remain undiagnosed and could benefit from therapeutic treatment [2]. Recent evidence suggests the magnitude of the problem is increasing over time [3].

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TARGETING THE DRY EYE INFLAMMATORY CYCLE

Dry Eye Disease (DED) is caused by several factors and affects the various tissues composing the ocular surface. Irritation creates inflammation that over time destabilizes the tear film and worsens patient symptoms. When compromised, the tear film may leave portions of the ocular surface uncovered, or cause tears to become unhealthy in composition. In both cases the corneal surface becomes further exposed to irritating effects that exacerbate the inflammatory cycle and worsen patient symptoms.

SDP-4 is designed to simultaneously stabilize the tear film with protein while inhibiting inflammation that can cause Dry Eye symptoms.

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“SILKTECH’s SDP-4 represents an exciting and potentially disruptive treatment approach to several, common ocular surface disorders, including dry eye.”
— Emmett T. Cunningham, Jr, MD, PhD,
MPH, an internationally recognized ocular inflammatory disease expert
Enhanced Tear Film Stability

The tear-film enhancing protein nature of SDP-4 is demonstrated by comparing the spreading properties of saline vs. saline plus SDP-4 on a surface that models a Dry Eye Disease (DED) surface. SDP-4 (1%) acts to enhance the wetting and spreading properties upon application without increasing viscosity. This design aims to improve overall tear film stability in DED patients to enhance their comfort without compromising their vision quality.

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THE PRODUCT - SILK-DERIVED PROTEIN-4 (SDP-4)


SDP-4 offers a unique therapeutic approach that uses a naturally derived silk protein to treat DED. The SDP-4 drug candidate has been designed to inhibit inflammation that creates DED symptoms while simultaneously improving the spreading and wetting properties of the eye drop on the ocular surface to improve patient comfort.

DED IS A SIGNIFICANT PROBLEM BOTH IN THE US AND WORLDWIDE


It is estimated that up to 340 million people suffer from Dry Eye Disease (DED) worldwide, with 45 - 60 million people in the US alone. Estimates show that nearly 16 million patients are diagnosed with DED in the US [1], and further studies suggest up to an additional 30 – 40 million individuals may remain undiagnosed and could benefit from therapeutic treatment [2]. Recent evidence suggests the magnitude of the problem is increasing over time [3].

Track Our Progress
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TARGETING THE DRY EYE INFLAMMATION CYCLE


DED is caused by several factors and affects the various tissues composing the ocular surface. Irritation creates inflammation that over time destabilizes the tear film and worsens patient symptoms. When compromised, the tear film may leave portions of the ocular surface uncovered, or cause tears to become unhealthy in composition. In both cases the corneal surface becomes further exposed to irritating effects that exacerbate the inflammatory cycle and worsen patient symptoms.

SDP-4 is designed to simultaneously stabilize the tear film with protein while inhibiting the inflammation that causes DED.

Image
“SILKTECH’s SDP-4 represents an exciting and potentially disruptive treatment approach to several, common ocular surface disorders, including dry eye.”
— Emmett T. Cunningham, Jr, MD, PhD,
MPH, an internationally recognized ocular inflammatory disease expert
Enhanced Tear Film Stability

We are a highly innovative biotech company with patented technology that uses silk protein to develop biological drugs designed to treat eye disease and reduce dry eye symptoms.
More About SDP-4
THE SDP-4 EYE DROP PRODUCT PROFILE

Because of SDP-4’s unique solubility properties, the eyedrop formulation is water-based. Also, the formulation is non-preserved and stable at room temperature.

“The field of protein-based treatments for dry eye is significant and could represent one of the key mechanisms to managing this vast disease. SDP-4 is a prime example of how this silk protein may affect lubrication, inflammation and ocular surface healing.”
— Paul Karpecki, OD,
Leading expert in the field of dry eye disease
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THE SDP-4 EYE DROP PRODUCT PROFILE

We are a highly innovative biotech company with patented technology that uses silk protein to develop biological drugs designed to treat eye disease and reduce dry eye symptoms.
“The field of protein-based treatments for dry eye is significant and could represent one of the key mechanisms to managing this vast disease. SDP-4 is a prime example of how this silk protein may affect lubrication, inflammation and ocular surface healing.”
— Paul Karpecki, OD,
Leading expert in the field of dry eye disease
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AN EXCITING JOURNEY OF DISCOVERY AND INNOVATION

Silk Tech recently had a pre-IND meeting with the FDA and is on track for an IND submission in Q1 of 2019.  The company plans to begin a Phase IIB clinical trial in early 2019 to assess the safety and efficacy of SDP-4 to treat the signs and symptoms of Dry Eye Disease (DED), pending IND submission.  The company hopes to receive top line results of the study by Q1 of 2020.

Q1 2019

SilkTech is planning an IND submission in the first part of 2019.

Q2 2019

The company is planning a Phase 2 dose-response, vehicle-controlled study in patients with dry eye disease.

Q1 2020

The results from this clinical study are anticipated in early 2020.

About Silk Tech