Fighting Foundation Blindness (FFF) has granted Mireca Medicines GmbH the Translational Research Acceleration Program (TRAP) Award, totaling nearly $1 million.
Refresh me on Mireca.
Based in Germany, the preclinical-stage company specializes in developing inherited retinal disease (IRD) treatments and drug delivery technologies, including proprietary cyclic guanosine monophosphate (cGMP)-analogs.
Its lead cGMP program includes positive clinical data and neuroprotection for the following IRDs:
- Retinitis pigmentosa (RP)
- Leber’s Congenital Amaurosis (LCA)
- Stargardt’s disease
And this award?
The TRAP Award was established to advance preclinical research for an investigational new drug (IND) filing and into clinical trials to support a pipeline of potential therapies for IRDs, including dry age-related macular degeneration (AMD).
How will Mireca use this funding?
The company plans to continue advancing the preclinical development of its lead investigational asset: MM238, a patent-protected cGMP-analog in a novel sustained-release formulation.
The plan: to provide for a series of IND-enabling toxicology and translational (small participant-sized) proof-of-concept (PoC) studies.
Of note, PoC studies are usually early-stage clinical trials that seek to determine if an investigational product produces an expected response in its participants.
Hold up … wasn’t Mireca originally partnering to develop MM238?
Good memory!
Back in August 2022, Mireca and Graybug Vision Inc (now CalciMedica Inc) launched an IRD-focused collaboration to develop MM238 using then-Graybug’s proprietary sustained-release drug delivery technologies.
Fast forward to May 2023, the companies terminated the partnership due to CalciMedica deciding to move away from ocular disease drug development.
Did Mireca gain anything from it?
Yes, indeed they did.
Mireca gained all exclusive rights and access to technologies that had been developed during the 10-month collaboration—including a new patent application with formulation and release data for select cGMP-analogs that were part of CalciMedica’s sustained-release drug delivery technologies.
See here for more details on that.
Gotcha. So is there any pre-clinical data on this asset so far?
There is!
The company reported that the formulation has previously exhibited an intraocular retention and release profile, supporting life-long patient compliance.
“We have demonstrated proof-of-concept in preclinical IRD-models, with a favorable safety profile and tolerability window, and upscaled the small molecule manufacturing to GMP-grade,” stated Mirecoa’s Francois Paquet-Durand, PhD, scientific founder and principal investigator of the MM238 program.
And what’s next?
Mireca plans to complete product development and manufacturing of MM238 before conducting scientific advice meetings and the PoC studies, as well as utilize FFF’s network resources through each stage of research and development.
The end goal: an IND filing with the FDA.