HONG KONG – Osaka, Japan-based Shionogi & Co. Ltd. has inked a license agreement with Bioage Labs Inc. that sets the stage for the Richmond, Calif.-based startup to test asapiprant, originally developed for allergic rhinitis, for the treatment of COVID-19 and age-related declines in immune function. The deal, which included an up-front payment, potential milestones and royalties for Shionogi, gives Bioage rights to develop and commercialize the DP1 receptor antagonist to treat COVID-19 in the U.S., U.K. and Europe. Bioage is advancing the program as BGE-175.

Venture-backed Bioage, which raised $90 million in an oversubscribed series C financing in December, identified asapiprant’s antagonism of the prostaglandin D2 DP1 receptor as having the potential to restore function across several key immune mechanisms dysregulated with aging. The same mechanisms could be critical for mounting an effective response to COVID-19 infection. Building on that finding, the company intends to initiate a phase II trial testing the drug against COVID-19 in the first half of this year.

Bioage, which identified BGE-175’s mechanism of action as a promising area in which to focus its team’s energies is starting work with a solid package. “Shionogi’s previous clinical trial data demonstrate that BGE-175 inhibits PGD2 signaling with clear target engagement. In addition, their safety database comprises over 2,400 subjects across multiple clinical trials for allergic rhinitis,” a Shionogi spokeswoman told BioWorld.

Further research could elucidate even more applications for the candidate, Bioage CEO Kristen Fortney told BioWorld. “BGE-175 has broad potential to improve the host immune response of older people to multiple viral and bacterial respiratory infections. We are considering trials for influenza and RSV infection, subject to Shionogi granting Bioage a license for additional indications within our one-year exclusive negotiation period,” she said.

Improving lifespan, healthspan

Since its founding in 2015, Bioage has raised $127 million in venture capital funding to back its AI-driven approach to map the molecular pathways that impact human longevity. Its name, Forney said, “reflects the company's focus on aging. Aging is the root cause of many severe diseases, and we believe that studying these diseases through the lens of aging will reveal important new drug targets.” This deal and the company’s upcoming trials could help validate both the company’s platform and strategy, she said.

“Using a target identification platform based on proprietary longitudinal biobank data, we identify clinical-stage assets that modulate molecular determinants of healthy human aging and have been demonstrated to be safe in humans. We then in-license these assets from pharma partners and initiate clinical development for severe diseases of aging.”

In addition to BGE-175, Bioage has in-licensed from Taisho Pharmaceutical Co. Ltd. BGE-117, an inhibitor of hypoxia-inducible factor prolyl hydroxylase that it’s developing for muscle-related indications. A phase II efficacy trial of BGE-117 is also planned for the first half of this year.

COVID-19 work continues at Shionogi

Meanwhile, Shionogi is continuing its own work on the COVID-19 front, developing a recombinant protein vaccine that is now in a combined phase I/II trial in Japan.

The trial is a randomized, double-blind and placebo-controlled study testing multiple doses of antigen protein and adjuvant in combination. More than 200 Japanese adults are enrolled in the trial, which started in December 2020.

“Besides BGE-175, we are developing a therapeutic drug and are currently conducting nonclinical trials. We are also developing an antigen diagnostic kit in collaboration with Japanese academia,” said Shionogi’s spokesperson.