FDA clears investigational new drug application for Zabalafin Hydrogel
Key takeaways:
- Zabalafin Hydrogel is a novel, first-in-class, multi-target therapeutic plant-based drug.
- Phase 2b and phase 3 trials may begin in 2025 and 2026, respectively.
- A new drug application is anticipated for 2029.
The investigational new drug application for Zabalafin Hydrogel for the treatment of mild to moderate atopic dermatitis has been cleared by the FDA, Alphyn Biologics announced in a press release.
“This is an important milestone for Alphyn as we advance what we believe will become the drug of choice for atopic dermatitis or eczema patients and their physicians,” Neal Koller, CEO of Alphyn Biologics, told Healio. “Zabalafin Hydrogel is the leader in the shift to a complete treatment approach for AD and has the potential to offer patients substantial benefits over current drugs.”
As Healio previously reported, Zabalafin Hydrogel (AB-101a, Alphyn Biologics) is a novel, first-in-class, multi-target therapeutic plant-based drug for the treatment of AD.
Zabalafin not only addresses itch, but also the immune-inflammatory and bacterial components of the disease.
So far, the two phase 2a trials of Zabalafin in this indication have met all primary and secondary endpoints. Furthermore, this nonsteroidal topical has demonstrated an excellent safety and patient tolerability profile, which Koller said “could make it a compelling choice for long-term, continuous use.”
According to the release, the company anticipates the initiation of the global phase 2b trials of Zabalafin in the first quarter of 2025.
Koller also told Healio that phase 3 trials should begin in 2026, whereas the new drug application submission is anticipated for 2029.