NVI-100 is a first-in-class soluble peptide CGRP receptor antagonist given subcutaneously via patient-friendly autoinjector, with the goal of bypassing migraine-associated gastrointestinal symptoms such as nausea, vomiting, and gastric stasis.
NVI-100 was engineered to provide high solubility and stability in water-based formulations. These unique features enabled the development of a rapidly absorbed subcutaneous formulation, with the goal of overcoming common limitations of existing migraine medications.
OUR APPROACH
At Nuvie Bio, we are targeting the calcitonin gene-related peptide (CGRP) receptor.
Decades of basic and clinical science have established that CGRP promotes migraine attacks.
Calcitonin gene-related peptide (CGRP)
Clinical studies have shown that CGRP is released during migraine attacks, infusion of CGRP produces migraine in patients, and blocking CGRP or CGRP receptors is clinically efficacious in treating migraine.
These findings have led to the development and approval of a first wave of CGRP-targeted therapies, both for the acute and preventive treatment of migraine. While a significant advancement in migraine treatment, these medications have important limitations.
1
Nuvie Bio’s peptide technology
At Nuvie Bio, we have implemented advanced peptide chemistry to design the next generation of improved CGRP receptor antagonists.
The first wave of acute treatment CGRP receptor antagonists focused on oral delivery of small molecules.
At Nuvie Bio, we are prioritizing efficacy, focusing on identifying therapeutic candidates with fast onset and high and consistent efficacy, with the development of a rapidly absorbed subcutaneous peptide.
NVI-100* is a first-in-class soluble peptide CGRP receptor antagonist given subcutaneously via a patient-friendly autoinjector, bypassing migraine-associated gastrointestinal symptoms such as nausea, vomiting, and gastric stasis.
NVI-100 was purposely engineered to provide high solubility and stability in water-based formulations. These unique features enabled the development of a small volume, rapidly absorbed subcutaneous formulation to overcome common limitations of existing migraine medications.
Nuvie Bio’s next generation CGRP receptor antagonist
Nuvie Bio is developing NVI-100, a potentially transformative new acute therapeutic candidate for migraine specifically designed to deliver “speed to relief that is tolerable”, thereby reducing trade-offs between efficacy and side effects.
2
A Phase 1 clinical trial in healthy volunteers has shown that NVI-100 is well tolerated and produces rapid, high, and consistent plasma levels, which has potential to deliver an unprecedented combination of speed to relief and high and consistent efficacy, which will be evaluated in the planned Phase 2 clinical program.
Based on existing data, NVI-100 is primarily cleared by the kidney which may help to improve the safety profile and reduce potential drug-drug interactions compared to drugs that are metabolized by the liver.
NVI-100 has the potential to become the first acute treatment for migraine that reduces the need to choose between efficacy and tolerability. We believe this can ultimately increase adherence and persistency, thereby optimizing migraine treatment and decrease the risk for disease progression.
3
References
-
Goadsby PJ. Calcitonin gene-related peptide antagonists as treatments of migraine and other primary headaches. Drugs. 2005;65(18):2557-2567.
-
Srinivasan K, Kozminski K, et al. Pharmacological, Pharmacokinetic, Pharmacodynamic and Physicochemical Characterization of FE 205030: A Potent, Fast Acting, Injectable CGRP Receptor Antagonist for the Treatment of Acute Episodic Migraine. J Pharm Sci. 2022 Jan;111(1):247-261.
-
On file at Nuvie Bio, Inc.​
* Disclaimer: None of our product candidates has been approved by any regulatory authority or deemed safe or effective for any indication. Information about our product candidates are subject to change based on ongoing testing.