![]() The company also hired Dhaval Desai, PharmD, as their Chief Development Officer and recently hired Chris Simms as their Chief Commercial Officer. Dugel was promoted to become the company’s president in May 2021. We’re really a science-driven company focused on patients and focused on retinal diseases for which there is no treatment.”ĭr. It’s the belief that if the science is done properly, the shareholder value will follow. “This was an opportunity to drive decisions based on science that will serve providers and patients. “This is a situation where we are going where nobody’s gone before, and that to me was extraordinarily attractive,” Dr. Dugel said. ![]() Dugel had been tracking Iveric and its pipeline. Over the course of his decades-long career as a private practice retina physician and practice owner, and through his interactions with industry, Dr. Dugel, MD, as Chief Business and Strategy Officer in March 2020. That idea would soon be put into practice with the hire of Pravin U. The data release from GATHER1 also affirmed the philosophy Mr. Sblendorio has continually sought to instill in the company culture-if Iveric can establish strong scientific rationale for its pipeline candidates, the market will follow. Following a brief pause to the GATHER2 program as a result of COVID-19, this momentum would continue, when the company raised an additional approximately $150 million in net proceeds in June 2020. On the heels of a positive data release, the company started preparing for GATHER2 in earnest and raised approximately $42.5 million in net proceeds in December 2019 to fund the study. In hindsight, the release of 12-month data from GATHER1 was a bellwether moment for Iveric. In 2017 we started the revamped Zimura program in 2018, we finished enrollment in GATHER1 and in October 2019, we turned the card with the results from GATHER1,” Mr. Sblendorio said. “We were limping along over the next couple of years. Although the science behind complement’s role in AMD pathogenesis is well known in the clinical ophthalmic community, a play for a GA treatment seemed a risky pursuit to those external to the company. However, despite internal alignment, the investor community continued to express skepticism around complement inhibition. In April 2019, the company officially changed its name to Iveric Bio, a play on the Latin veritas, meaning truth. “We were aiming for several targets, but our biggest bet was on GA,” Mr. Sblendorio, the board opted for three smaller studies for Zimura: an open-label phase 2 study investigating Zimura administered in combination with Lucentis® (ranibizumab, Genentech) for the treatment of wet AMD (NCT02397954) a phase 2b study testing Zimura in autosomal recessive Stargardt disease (NCT03364153) and a modification of the existing GATHER1 study (previously OPH2003 NCT02686658), a sham-controlled study for treatment of GA secondary to AMD (NCT02686658), based on positive data from a competitor’s complement inhibitor in development for GA with the goal of getting a data read out as efficiently as possible. As for Zimura, a strong signal of therapeutic benefit with a favorable safety profile in previous phase 1 and 2 studies in dry AMD and wet AMD, 5 together with a strong scientific link between complement activation and deposition and retinal disease, 6-8 provided the rationale to forge ahead with multiple Zimura development programs.Īccording to Chief Executive Officer Glenn P. The acquisitions would be guided by three strict criteria: they had to (1) be backed by great science performed by leading scientists (2) seek to address a significant unmet medical need and (3) be associated with market viability. 4 The board of directors decided to wind down the company’s Fovista development program and to conduct a review, which resulted in the strategy to diversify the company’s portfolio by repositioning the promising Zimura asset already in clinical development with programs in multiple indications, and to embark on a strategy to acquire rights to additional assets (IC-500 and several gene therapy assets). In 2017, what was then called Ophthotech Corporation saw its phase 3 Fovista® (pegpleranib) trials fail to meet their prespecified primary endpoints. An Unexpected (but Fortuitous) Change in Focus 2,3 Iveric works toward cultivating a deep and nuanced understanding of the pathophysiology associated with retinal diseases and then guides drug development efforts based on the data. Its work in complement illustrates that intention: inhibiting C5 preserves crucial physiologic function initiated at earlier steps in the complement pathway while still shutting down activation of inflammatory processes and cell-killing membrane attack complex (MAC). Iveric aims to lead with the strength of its science.
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