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OPKO Health and Entera Bio Expand $50M Oral Peptide Therapy Partnership

OPKO Health, Entera Bio Expand Partnership to Advance Oral Peptide Therapies

Edited by Robert McTiernan··3 min read

OPKO Health, Entera Bio Expand Partnership to Advance Oral Peptide Therapies

Biopharma partners OPKO Health and Entera Bio have expanded their collaborative agreement to advance two innovative oral peptide therapies, including a first-in-class oral PTH tablet targeting hypoparathyroidism and a dual-action metabolic disease candidate, the companies announced.

The expanded partnership builds on their existing collaboration, with both companies increasing their joint development efforts across two key therapeutic programs. Under the terms of the expanded agreement, OPKO and Entera will jointly develop a long-acting PTH therapy for hypoparathyroidism, maintaining a 50/50 ownership and cost-sharing structure.

Hypoparathyroidism Treatment Takes Center Stage

The oral PTH tablet represents a potentially transformative approach to managing hypoparathyroidism, a rare endocrine disorder characterized by insufficient parathyroid hormone production. Current treatment options are limited, typically involving daily calcium supplements and vitamin D analogs that do not address the underlying hormone deficiency.

"Our goal is to provide patients with hypoparathyroidism a more convenient treatment option that eliminates the burden of daily injections while maintaining therapeutic efficacy," said Phillip Frost, M.D., Chairman and CEO of OPKO Health.

The companies have demonstrated promising preclinical data supporting a single, once-daily tablet formulation. Entera's proprietary N-Tab® oral peptide platform enables the delivery of peptides traditionally restricted to injectable administration, potentially revolutionizing treatment approaches for complex endocrine disorders.

Metabolic Disease Program Expands

Concurrent with the hypoparathyroidism program, the OPKO Health partnership will continue advancing an oral oxyntomodulin (OXM) therapy targeting metabolic and fibrotic disorders. The dual GLP-1/glucagon receptor agonist represents an innovative approach to addressing obesity and related metabolic conditions.

Key Development Milestones

The collaboration targets several critical near-term milestones:

  • Filing an investigational new drug (IND) application for the oral PTH tablet in late 2026
  • Initiating Phase 1 clinical studies for injectable oxyntomodulin
  • Preparing for subsequent oral OXM tablet clinical development

Platform Technology Drives Innovation

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Entera Bio's N-Tab® oral peptide platform sits at the core of these development efforts, offering a potentially disruptive approach to peptide drug delivery. The technology addresses significant challenges in oral peptide administration, including enzymatic degradation and poor bioavailability.

"The partnership that our team has forged with OPKO since late 2023 has been very synergistic," said Miranda Toledano, CEO of Entera Bio. "Preclinical data of our oral long-acting PTH suggests this program holds the potential to transform the hypoparathyroidism landscape."

Strategic Leadership Transition

The partnership announcement coincides with a leadership change, with OPKO executive Steve Rubin joining Entera's board of directors. Rubin brings three decades of experience in corporate governance and strategic drug development oversight.

Market Implications

The collaboration highlights a growing trend in biopharma toward more patient-friendly, convenient therapeutic approaches. Oral peptide therapies represent a significant potential advancement over traditional injectable treatments, potentially improving patient adherence and quality of life.

Competitive Landscape

While several GLP-1 and PTH therapies exist in the market, the oral delivery mechanism distinguishes this partnership. Current treatments for hypoparathyroidism and metabolic disorders often require daily injections, creating a substantial unmet medical need that oral formulations could address.

Looking Ahead

As the partnership progresses, investors and healthcare professionals will closely watch the development of these innovative oral peptide therapies. The combination of OPKO's protein chemistry expertise and Entera's oral delivery platform represents a potentially transformative approach to challenging therapeutic areas.

The expanded collaboration underscores the continued innovation in peptide-based therapeutics and the ongoing quest to develop more patient-friendly treatment modalities.

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