Less than 10 months after announcing an exclusive partnership, Mireca Medicines GmbH and Graybug Vision Inc. (now CalciMedica Inc.) have ended their inherited retinal disease (IRD)-focused collaboration.
Refresh me on the players.
Mireca is a preclinical-stage company focused on developing inherited retinal disease (IRD) treatments and drug delivery technologies, including proprietary cyclic guanosine monophosphate (cGMP)-analogs.
Graybug Vision (recently merged under the new name CalciMedica) was a clinical-stage biopharmaceutical company targeting the development of therapies and proprietary technology for life-threatening inflammatory diseases with a high unmet need.
CalciMedica is a clinical-stage biopharmaceutical company focused on developing therapies for life-threatening inflammatory diseases with high unmet need.
CalciMedica’s proprietary technology targets the inhibition of CRAC (calcium release-activated calcium) channels designed to modulate the immune response and protect against tissue cell injury.
Talk about the initial agreement.
Announced in August 2022, the partnership was intended to develop Mireca’s proprietary cGMP for treating inherited retinal diseases—including retinitis pigmentosa (RP), Leber’s Congenital Amaurosis (LCA), and Stargardt's disease—via Graybug’s proprietary sustained-release drug delivery technologies.
Keep going …
Graybug Vision was to acquire exclusive access to Mireca’s inventory of protein kinase G (PKG) modulators and take over the research, development, manufacturing, and commercialization of Mireca’s cGMP analogs for both eye and ear treatment.
Mireca was to also transfer an orphan drug designation (ODD) status to Graybug Vision for RP treatment.
So what went wrong?
To put it simply, CalciMedica (as Graybug is now known as) decided to move away from ocular disease drug development.
That’s it?
Pretty much. All exclusive rights and access Graybug received under the partnership (as outlined above) are now reverting back to Mireca’s ownership.
This also included a new patent application that included formulation and release data for select cGMP-analogs that were part of Graybug’s sustained-release drug delivery technologies.
Any other technologies that were created?
Yes! Mireca now owns the following:
- An improved, patent-protected cGMP-analog (selected as lead compound)
- A new proprietary manufacturing process (adhering to the FDA’s standards good manufacturing practice [GMP])
- cGMP-analog slat forms produced via the new manufacturing process
So what’s next?
Mireca plans to continue development of the lead compound and formulation combination (dubbed MM238) as its internal lead product, with the goal of creating a treatment for IRDs.