Existing progesterone formulations for Traumatic Brain Injury (TBI) are not suitable for commercial development because they are imprecisely formulated at the bedside, resulting in potential variations in drug dosing and the failure to meet strict release specifications required by regulatory authorities. In addition these formulations lack intellectual property protection and contain components that are not suitable for long-term infusion.
AT-PGS-371 was developed to obviate these deficiencies and generate a progesterone based neuroprotection product suitable for approval and that would justify the requisite development investment. AT-PGS-371 comes in a lyophilized format that can easily be reconstituted at the hospital bedside or by the emergency medic at accident site to meet strict QC specifications. The proprietary formulation contains FDA-approved excipients that are suitable for extended bolus and prolonged infusion. Today’s announced completion of a 24 month stability study concludes a three year development project and establishes a two year shelf life for AT-PGS-371 and clearly shows that the NanoBindi based formulation can be easily reconstituted to meet the product release specifications. These data satisfy the clinical requirements for a commercially viable progesterone formulation product.
Arkesh Mehta, Avanti’s CEO, stated, “We believe AT-PGS-371 will enable the transition of progesterone from a research tool to a commercially viable product. The lack of patent protection and an approvable formulation have impeded the development of progesterone therapeutics for TBI.
Dr. Mehta, further added, “The current study clearly establishes the capability for the multifunctional nanoparticle based progesterone to be easily reconstituted and to meet key stringent release specifications. Multi-functional NanoBindi based product manufacturing offers a number of compelling benefits, including flexible modular product design and reduced development cost and time. While production and regulatory processes for biological products are often complex and time consuming,
Avanti's NanoBindi based products can be developed and approved faster for the following reasons:
- Simple and easily scalable technology enables design variations that are analogous to structure–activity relation analyses used in small molecule research.
- Modular, biodegradable and biologically safe building blocks enable robust and rapid product development.
- Demonstrated scalability is based upon use of established biopharmaceutical unit operations and processes.
- Avanti Therapeutics is now seeking development partners for AT-PGS-371 to pursue an accelerated 505(b) (2) NDA registration and commercialization strategy for specific neurological indications including TBI, stroke and spinal cord injury.
For more information on Avanti Therapeutics’ patient-friendly CNS products please visit www.AT-GC.com.
Contacts
Avanti Therapeutics, Inc.
Jenny Smith
202-677-5458
Jenny@at-gc.com
