BioCryst Pharmaceuticals and Clearside Biomedical announced a licensing deal for avoralstat, aimed at treating diabetic macular edema (DME) via Clearside’s SCS Microinjector®. This partnership may enhance DME treatment efficacy with fewer doses and expand treatment options beyond anti-VEGF therapy. Avoralstat, once tested for hereditary angioedema, will enter proof-of-concept trials as a promising DME solution. Clearside could receive up to $82.5 million in milestone payments plus royalties, with BioCryst hosting an R&D event to discuss further pipeline developments.
BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) and Clearside Biomedical, Inc. (Nasdaq: CLSD) today announced the entry into a license agreement enabling BioCryst to develop its investigational plasma kallikrein inhibitor, avoralstat, with Clearside’s SCS Microinjector® to deliver avoralstat directly to the back of the eye through the suprachoroidal space to treat patients with diabetic macular edema (DME).
“Many DME patients are not effectively controlled with anti-VEGF therapy, so it is exciting to target plasma kallikrein by combining avoralstat with delivery into the suprachoroidal space using Clearside’s proprietary SCS Microinjector. Our collaboration provides an opportunity for us to advance the development of avoralstat into a proof-of-concept trial as a potential best-in-class medicine that can offer new hope to patients living with DME,” said Jon Stonehouse, president and chief executive officer of BioCryst.
Avoralstat has high potency and low solubility, which are two characteristics important to achieving potential efficacy with reduced dosing frequency in the eye for DME patients. Delivering avoralstat directly into the suprachoroidal space could allow avoralstat to inhibit plasma kallikrein at the sites of edema formation in DME disease, the retinal and choroidal vascular endothelium.
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Avoralstat was previously evaluated in an oral formulation in a Phase 3 clinical trial in patients with hereditary angioedema (HAE). In the HAE clinical trial program in 276 individuals, oral avoralstat was safe and well tolerated with an adverse event profile similar to placebo.
“Treating patients with DME by delivering avoralstat directly to the suprachoroidal space using the SCS Microinjector expands the reach of our proprietary SCS injection platform to a greater number of patients. We are proud to partner with BioCryst to help bring a potential new treatment to patients who are underserved by current therapies for DME,” said George Lasezkay, Pharm.D., J.D., president and chief executive officer of Clearside.
Under the terms of the agreement, Clearside will receive a $5 million upfront license fee from BioCryst. Clearside is eligible to receive up to an additional $30 million in clinical and regulatory milestone payments, and up to a total of $47.5 million in three post-approval sales-based milestone payments as annual global net sales progress to $2 billion.
BioCryst will pay Clearside tiered mid-single digit royalties on annual global net product sales, at three tiers, including a top tier of >$1.5 billion.
DME is the most common cause of vision loss in individuals with diabetes and at least one-third of patients have persistent DME despite treatment with anti-VEGF therapies, which are administered via monthly injection. Data have shown that elevated kallikrein may be a cause of non-response to anti-VEGF therapy.
BioCryst R&D Day
BioCryst will host a Research and Development (R&D) Day at 1:00 pm ET today at its Discovery Center of Excellence in Birmingham, AL. At the R&D Day, BioCryst plans to describe its drug discovery process and introduce additional therapies from its pipeline. The live webcast and replay of the R&D Day will be available online in the investor’s section of the BioCryst website at www.biocryst.com.
Source: Biospace