Zelos Therapeutics Initiates Dosing in Clinical Study of Nasal Spray Teriparatide Formulation
Zelos Therapeutics, Inc. has initiated a seven-day clinical study of a nasal spray formulation of ZT-034 (teriparatide), a non-injectable alternative to Eli Lilly and Company's Forteo (teriparatide [rDNA origin]). The study aims to evaluate the efficacy and safety of the nasal spray formulation in comparison to the marketed product. The development of non-injectable formulations, such as nasal spray ZT-034, could expand the market for parathyroid hormone (PTH) analogs to over $1 billion.
Key Takeaways:
- Zelos Therapeutics has initiated dosing in a seven-day clinical study of a nasal spray formulation of ZT-034 (teriparatide) developed in collaboration with Aegis Therapeutics, LLC.
- The nasal spray formulation is designed to offer a simple and convenient alternative to the daily injections of Forteo, which generated $800M in annual sales in 2009.
- The study will include a Forteo treatment arm to provide an initial comparison with the marketed product.
- Aegis Therapeutics' proprietary agent Intravail[R] is used to create a stable solution of teriparatide and enhance absorption of the peptide across the nasal mucosal surface.
- Zelos Therapeutics plans to develop nasal spray ZT-034 under the 505(b)(2) regulatory pathway, which permits companies to obtain FDA approval by relying on the agency's findings of safety and/or efficacy for a previously approved drug.
- Aegis Therapeutics' Intravail[R] technology has been successfully applied to intranasal administration of peptides, resulting in dramatic increases in bioavailability.
Statistics:
- Annual sales of Forteo in 2009: $800M
- Potential market size for parathyroid hormone (PTH) analogs: over $1 billion
- Number of days: seven (duration of the clinical study)
- Number of participants: not specified
Sources:
- Zelos Therapeutics, Inc. press release
- Aegis Therapeutics, LLC press release
- Clinical Trials Week editors' report on NewsRx.com (2010)