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Mireca awarded USD 989,000 from the Foundation Fighting Blindness
Mireca receives the Translational Research Acceleration Program (TRAP) Award of USD 989,000 from the renowned US-based Foundation Fighting Blindness.
The lead program of Mireca, a patent protected cGMP-analog in a novel sustained-release formulation (MM238), will be further advanced towards the clinic by these funds, that provide for a series of IND-enabling toxicology and translational proof-of-concept studies.
As TRAP Awardee Mireca may participate in the Foundation Fighting Blindness’ mentorship program and is granted access to the Foundation’s network, spanning across all stages from bench to bedside.
The Foundation Fighting Blindness thus boosts Mireca’s progress in developing MM238 for inherited retinal diseases across a wide range of genetic mutations.
TÜBINGEN, GERMANY, January 29th, 2024 — Mireca Medicines GmbH, an ophthalmology company formed to develop treatments for inherited retinal diseases today announces it received a USD 989,000 Translational Research Acceleration Program Award from the renowned Foundation Fighting Blindness. The funds will permit Mireca to further advance the preclinical development of its lead product MM238.
By becoming an awardee of this competitive funding, the Foundation recognizes Mireca’s leading contribution to unlocking the potential of targeting the cGMP pathway to treat inherited retinal diseases (IRD) like Retinitis Pigmentosa (RP), Leber Congenital Amaurosis, and Stargardt’s disease. A wide range of mutations in at least 30% of these patients trigger excess levels of cGMP, thus over-activating the enzyme protein kinase G (PKG) which further down the signaling cascade causes the loss of photoreceptors. Mireca has developed proprietary cGMP-analogs that inhibit PKG, thereby halting photoreceptor degeneration which preserves retinal structure and function.
During the TRAP project Mireca will continue developing its proprietary lead program MM238, a cGMP-analog in a tailored PLGA-based formulation, which is protected by a strong intellectual property estate. The formulation has previously shown an intraocular retention and release profile that supports life-long patient compliance. Product development and manufacturing will be followed by scientific advice meetings, safety, toxicology and translational proof-of-concept studies, all aimed at an Investigational New Drug (IND) filing. In performing these efforts, Mireca may tap into the Foundation’s strong network across all research and development stages, especially by consulting Dr. Cheryl L. Rowe-Rendleman, a regulatory and clinical senior executive, who the Foundation Fighting Blindness has assigned as project mentor.
“Our research and development journey started with understanding the photoreceptor cell death mechanism. It took us through developing a novel class of small molecules that can regulate this disease pathway in combination with drug delivery formulations that are suitable for chronic ocular treatment. 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. Being awarded with funds, network and mentoring from the Foundation Fighting Blindness to push our treatment approach further in its preclinical development is a significant reward and confirmation of our efforts. I am honored to be leading this TRAP project as principal investigator,” stated Prof. Dr. Francois Paquet-Durand, Mireca’s Scientific Founder.
“Mireca’s pioneering pan-mutation approach is convincing as it has the potential to treat a high percentage of patients suffering from inherited retinal degenerations, who have hardly any treatment options today,” said Chad Jackson, Ph.D., Senior Director at the Foundation Fighting Blindness.
About Mireca Medicines GmbH
Mireca Medicines GmbH, Tübingen (Germany), is an expanding, preclinical stage company pioneering the development of proprietary cyclic guanosine monophosphate (cGMP)-analogs and drug delivery technologies to treat diseases caused by a dysregulation of cGMP, affecting protein kinase G (PKG). Mireca’s lead program focusses on the inhibition of PKG for neuroprotection and has obtained positive preclinical data for inherited retinal diseases (IRD). IRD-type disease include Retinitis Pigmentosa (RP), Leber’s Congenital Amaurosis, and Stargardt’s disease.
About the Foundation Fighting Blindness
Established in 1971 in the Unites States of America, the Foundation Fighting Blindness is the world’s leading private funding source for retinal degenerative disease research. The Foundation has raised more than $915 million toward its mission of accelerating research for preventing, treating, and curing blindness caused by the spectrum of blinding retinal diseases including: Retinitis Pigmentosa, macular degeneration, and Usher syndrome. Visit FightingBlindness.org for more information.
About the Translational Research Acceleration Program
The Translational Research Acceleration Program (TRAP) awards will accelerate the movement of preclinical research toward an Investigational New Drug filing and into clinical trials to provide a robust and diverse pipeline of potential therapies to fight inherited retinal diseases (IRD) and dry age-related macular degeneration.
About Inherited Retinal Diseases (IRD)
Grouped under the term “Inherited Retinal Diseases,” Retinitis Pigmentosa, Leber’s congenital amaurosis, and Stargardt’s disease often result in the degeneration and loss of the light-sensitive cells in the retina, the so-called photoreceptors. This leads to severe visual impairment and eventually blindness. IRD are caused by a genetic defect in a single gene, out of more than 280 possible genes. Patients with these conditions may develop symptoms in early childhood, including night blindness or the inability to see parts of the world in front of them. They can take abnormally long periods of time to adjust to changes in lighting, and some patients may even find light uncomfortable. Individuals affected by IRD will gradually lose their sight and, unfortunately, most forms of IRD remain untreatable to this day.
For further information, please contact
Mireca Medicines GmbH
Barbara Brunnhuber, CEO
M: +31 6 23 93 69 66
E: bb@mireca.eu
Mireca reacquires all and more rights from Graybug Vision deal
04.05.2023, Mireca has been (re)assigned all intellectual property rights that Mireca had previously sold to Greybug, as well as acquired an additional patent application for cGMP-analogs in Graybug’s sustained drug delivery technology. A patent was issued for a new lead cGMP-analog, and a proprietary GMP manufacturing process was developed and material for pre-clinical development was manufactured. The patent protected cGMP-analog in a novel sustained-release formulation (MM238) for Inherited Retinal Disease will be further developed by Mireca.
Mireca signs transformative deal with Nasdaq-listed Graybug Vision
08.04.2022, Mireca has established an exclusive partnership with Graybug Vision, Inc. (Nasdaq: GRAY), a clinical-stage biopharmaceutical company focused on transformative medicines for ocular diseases, to develop Mireca’s proprietary cGMP analogues for the treatment of Inherited Retinal Diseases, such as Retinitis Pigmentosa, Leber’s Congenital Amaurosis and Stargardt’s disease, using Graybug’s proprietary sustained-release drug delivery technologies.
ARVO 2019: Emerging Drug for RP Evaluated in Safety & Tolerability Study
01.05.2019, FFB Eye on the Cure Research News, Francois Paquet-Durand, PhD, chief scientific officer at the company Mireca, discusses an emerging drug for Retinitis Pigmentosa, and other Inherited Retinal Diseases. The compound is active across many mutations and reaches the retina in a liposomal delivery system (like a "nano capsule"). The positive safety & tolerability study was presented in a poster at the 2019 meeting of the Association for Research in Vision and Ophthalmology (ARVO), April 28-May 2, 2019, in Vancouver, Canada.
Erbliche Netzhautdegeneration: Neuer RP-Wirkstoff vom Start-up
01.04.2018, transkript, Erbliche Netzhauterkrankungen, wie Retinitis pigmentosa (RP) betreffen mindestens zwei Millionen Menschen weltweit. Noch gibt es kaum Wege, die Degeneration der Stäbchenzellen in der Netzhaut und damit den fortschreitenden Sehverlust aufzuhalten. Ein Strukturanalogon des Signalmoleküls cGMP bremst den Verlust der Photorezeptoren bei ganz unterschiedlichen Krankheitsformen, berichteten Mitte Marz Forscher der Mireca Medicines GmbH, einer Ausgründung der Universitätsklinik Tübingen (PNAS, doi: 10.1073/pnas.1718792115).
Mireca announces publication detailing its cGMP approach in science journal PNAS
14.03.2018, Mireca announces the publication of an article by Eleonora Vighi et al. “Combination of cGMP analogue and drug delivery system provides functional protection in hereditary retinal degeneration”, in Proceedings of the National Academy of Sciences of the United States of America (PNAS).
Weiterer Schritt in der Entwicklung eines neuen Medikaments für erbliche Netzhautdegeneration. Aktuell im Wissenschaftsjournal PNAS veröffentlicht
14.03.2018, Universitätsklinikum Tübingen, Bei bestimmten seltenen Netzhauterkrankungen kommt es im Auge zum Absterben von Photorezeptoren, deren Ursache unterschiedliche krankheitsauslösende Mutationen sein können. Für die Entwicklung von Therapien besteht zudem die Herausforderung, dass die Netzhaut durch die sogenannte „Blut-Hirn-Schranke“ gegen die meisten Medikamente abgeschirmt ist. Jetzt ist es Wissenschaftlern des Forschungsinstituts für Augenheilkunde Tübingen, aus Lund (Schweden), Modena und Reggio Emilia (Italien) gelungen, einen Signalweg zu finden, über den eine neuartige Medikamentensubstanz diese Schranke passieren kann.