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Sunday, Jul 14, 2024

Weight-Loss Injections Reimagined with Needle-Free Tech

BIOTECH: Biora Innovating Smart Pills for Patients

San Diego biotech firm Biora Therapeutics (NASDAQ: BIOR) is working to deliver patients popular weight-loss medications in the form of so-called smart pills. Originally designed as diabetes drugs, GLP-1-based therapies – sold under brand names like Ozempic, Wegovy and Mounjaro, are currently only available as injections. Biora hopes to change that.

Adi Mohanty
Biora Therapeutics

“It’s no secret that people hate needles,” Biora CEO Adi Mohanty said. “The data show us that among people with diabetes who are receiving injectable GLP-1 agonist therapy, 42% of patients fail to maintain treatment because of injection concerns. There’s a 71% higher discontinuation rate for patients who start injectable GLP-1 therapy compared to those starting an orally delivered therapy. So we think our BioJet technology could really make a difference in improving disease management, by allowing patients to simply swallow a capsule.”

Biora’s BioJet – still in the early stages of development — is a swallowable capsule that’s about the size of a multivitamin. It’s designed to get the large-molecule medication through the harsh, acidic environment of the stomach and into the small intestine to maximize the body’s ability to absorb it. This July, the company presented new data on it at the American Diabetes Association meeting in San Diego, revealing that the capsules achieved an average of 37% oral bioavailability for so-called semaglutide, a type of GLP-1-based therapy being used for weight loss.

The data was accepted as a late-breaking abstract, meaning that scientists are eager to see where this all goes. “Late-breaking abstracts recognize novel, critically important research developments that occur after the deadline for abstracts to be submitted to a scientific meeting – essentially, research that shouldn’t wait until the next meeting,” added Mohanty. “It’s uncommon for preclinical data to be accepted as a late-breaker, and we think the fact that ours was accepted by the American Diabetes Association indicates the tremendous interest by the scientific community in solving the challenge of oral delivery of complex large molecules.”

Biora’s not the only company that’s working on oral delivery of medications that are typically taken via injection, but Biora says its technology is superior. “Those other approaches include the use of absorption enhancers in tablets or capsules, or ingestible devices that use a dissolvable microneedle. All of these other approaches require more complex reformulation of the product,” said Mohanty who added that reformulating drugs can be time-consuming, expensive and require additional testing.

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The company’s other tech platform is its NaviCap device, a swallowable capsule that is designed to deliver drugs directly to the site of disease in the large intestine for patients with inflammatory bowel diseases like Crohn’s disease and ulcerative colitis (UC). In the case of UC, the company is sending the drug tofacitinib to the large intestine to treat the affected area. Biora plans to file an investigational new drug application with the FDA during Q3 of this year to begin a phase 1 clinical trial toward the end of the year.

In July, Biora announced a group of new U.S. and European patents for the NaviCap technology that cover a range of therapeutic targets to treat UC.

Biora relaunched in 2022 after rebranding from its former name, Progenity, which dates back to 2010. It comes after the company agreed in 2020 to a $49 million settlement for overbilling federal health insurance programs and paying kickbacks to doctors who ordered Progenity’s prenatal genetic tests for their patients.

“When I joined the company, my task was to achieve a total transformation from the previous diagnostics business to a completely different industry,” said Mohanty of the switch to Biora. “The company had these therapeutics technologies that were unrelated to its core business, that it was kind of incubating in the background, and those became the focus of the new company. I’m proud of how the team has coalesced around our new focus and mission to deliver on the potentially transformative NaviCap and BioJet oral delivery platforms.”

He added, “We are now a smaller team that has the right talent and resources and is laser-focused on what we need to do to advance these needle-free therapeutics that could improve the lives of so many people.”

Biora Therapeutics

FOUNDED: 2010 as a diagnostics company
CEO: Adi Mohanty
REVENUE: $12.2 million (FY2022)
BUSINESS: biotech
WEBSITE: bioratherapeutics.com
NOTABLE: In July, Biora was awarded a group of U.S. and European patents related to its technology for several therapeutic targets.


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