Expert Insights: Targeted Therapeutics

From the eye to the gut, the following companies are advancing the standard of care for several different therapeutic areas.

“Outlook Therapeutics hopes to bring to market an investigational ophthalmic version of bevacizumab, a molecule that has been used to treat retinal disorders for several years but has never received approval from major regulatory agencies to be used as an ophthalmic drug solution. If our ophthalmic bevacizumab is approved, we will potentially enhance the standard of care for patients with disorders like wet AMD, diabetic macular edema, and branch retinal vein occlusion by removing concerns related to off-label repackaged IV product. We firmly believe that if a substance is to be injected into a patient's eye, it should meet the various requirements necessary to earn FDA approval for ophthalmic use.”

Russell Trenary, President & CEO, Outlook Therapeutics

“Our mission is to bring novel and transformative therapies to the anterior (front) chamber of the eye, particularly for the treatment of ocular surface disease. The company obtained its first FDA approval in 2021 for its Tyrvaya medication, the first and only nasal spray for the treatment of the signs and symptoms of dry eye disease.”

Jeffrey Nau, President & CEO, Oyster Point Pharma

“The company’s second pillar, brensocatib, is currently in a phase 3 clinical trial as the first investigational DPP1 inhibitor developed for neutrophil-driven inflammatory conditions… The drug is unique in that it targets the inflammatory process associated with bronchiectasis rather than the historically unsuccessful approach of treating with anti-infectives. Results from the phase 2 trial were published in the New England Journal of Medicine, the first time in nearly 20 years this journal has published on bronchiectasis.”

Will Lewis, Chairman & CEO, Insmed

“We are developing product candidates of standardized composition based on defined bacterial strains grown from clonal cell banks in a manner analogous to monoclonal antibody production… We believe that our targeted approach could offer consistent composition and quality attributes, provide more consistent clinical benefit, limit safety risk, and enable greater scalability compared with fecal-derived approaches.”

Bernat Olle, CEO, Vedanta Biosciences

“During the pandemic AzurRx BioPharma decided to acquire First Wave Bio, and the merged company was renamed First Wave BioPharma. Through the transaction and merger, we purchased full rights to First Wave’s proprietary formulations of niclosamide and exclusive international rights to develop oral and topical formulations of the compound for all gastrointestinal indications including Covid-related GI infections, IBD indications including ulcerative colitis (UC) and Crohn’s disease, and immune checkpoint inhibitor-associated colitis and diarrhea. We own the method of usage and delivery of these formulations as therapies for several auto-immune, inflammatory and viral ailments.”

James Sapirstein, Chairman, President and CEO, First Wave BioPharma

Image courtesy of CDC on Unsplash