A Multicenter, Multiple-Dose Study in Neovascular Age-related Macular Degeneration (nAMD) to Evaluate the Safety, Tolerability, Pharmacodynamics, Immunogenicity, and Clinical Effect of Repeat Intravitreal (IVT) Injections of GEM103 as an Adjunct to Standard of Care Aflibercept Therapy

This study is designed to investigate the safety and tolerability of GEM103 IVT injection + standard of care vs. sham + standard of care.

Start Date29 Dec 2020

Sponsor / Collaborator

Gemini Therapeutics, Inc.

NCT04643886 / TerminatedPhase 2

A Multicenter, Open-label, Multiple Dose Study in Patients With Geographic Atrophy Secondary to Dry Age-related Macular Degeneration to Evaluate the Safety, Tolerability, Pharmacodynamics, and Immunogenicity of Repeat Intravitreal Injections of GEM103

This study is designed to investigate the safety, PK/PD, biomarker and early clinical effects of repeat GEM103 IVT injections.

Start Date30 Jul 2020

Sponsor / Collaborator

Gemini Therapeutics, Inc.

NCT04246866 / CompletedPhase 1

A Phase 1, Multicenter, Open-label, Single-dose, Dose-escalation Study in Patients With Geographic Atrophy (GA) Secondary to Dry Age-related Macular Degeneration (AMD) to Evaluate the Safety, Tolerability, Pharmacodynamics, and Immunogenicity of Intravitreal Injections of GEM103

The study is designed to identify the maximum tolerated dose (MTD) for intravitreal (IVT) administration of GEM103 in subjects with geographic atrophy (GA) secondary to dry AMD. Safety and tolerability of a single dose of GEM103 will be assessed based on the occurrence of dose-limiting toxicities (DLTs). Each subject will be followed for safety, pharmacokinetic (PK), clinical, and biomarker evaluations. Three escalating dose cohorts are planned.

Start Date19 Dec 2019

Sponsor / Collaborator

Gemini Therapeutics, Inc.

100 Clinical Results associated with GEM-103

100 Translational Medicine associated with GEM-103

100 Patents (Medical) associated with GEM-103

Literatures (Medical) associated with GEM-103

03 Jul 2022·Current eye researchQ4 · MEDICINE

A Novel Full-Length Recombinant Human Complement Factor H (CFH; GEM103) for the Treatment of Age-Related Macular Degeneration Shows Similar In Vitro Functional Activity to Native CFH

Q4 · MEDICINE

Article

Author: Makou, Elisavet ; Lauder, Scott ; Herbert, Andrew P. ; Biggs, Robyn M. ; Barlow, Paul N. ; Katti, Suresh K.

PURPOSE:

GEM103 is a recombinantly produced full-length version of the human complement factor H (CFH) under clinical investigation for treatment of age-related macular degeneration (AMD) in individuals carrying an AMD risk-associated genetic variant of CFH. This study aimed to investigate the complement pathway-related functions of GEM103 in comparison with those of native human CFH.

METHODS:

Key biological activities of GEM103 and human serum-derived CFH (sdCFH) were compared using four independent functional assays. Assays of C3b binding and C3 convertase decay-accelerating activity (DAA) were performed by surface plasmon resonance (SPR). Cofactor activity (CA) was measured using 8-anilinonaphthalene-1-sulfonic acid as a fluorescent probe of C3b integrity. The abilities of GEM103 and sdCFH to protect sheep erythrocytes from hemolysis by CFH-depleted normal human serum were assessed colorimetrically.

RESULTS:

In multiple SPR-based assays of C3b binding and DAA, the performance of GEM103 was consistently comparable to that of sdCFH across a range of matching concentrations. The EC₅₀ ± SD in the fluorescence-based fluid-phase CA assay was 0.21 ± 0.06 µM for GEM103 compared to 0.20 ± 0.09 µM for sdCFH. In hemolysis assays, the EC₅₀ value of 0.33 ± 0.16 µM for GEM103 versus 0.46 ± 0.06 µM for sdCFH were not significantly different (p = 0.81).

CONCLUSIONS:

GEM103, a recombinant CFH developed by Gemini Therapeutics, shows activity profiles comparable to sdCFH in all complement-related assays employed in this study, suggesting that GEM103 is equivalent to the native glycoprotein in terms of its in vitro functional activity. These results support further study of GEM103 as a potential therapy for AMD.

01 Jun 2022·Ophthalmology science

A Phase I, Single Ascending Dose Study of GEM103 (Recombinant Human Complement Factor H) in Patients with Geographic Atrophy

Article

Author: Bakall, Benjamin ; Marcus, Dennis M ; Barone, Samuel B ; Pieramici, Dante ; Jamal, Karim N ; Couvillion, Stephen S ; Patki, Kiran C ; Dhoot, Dilsher S ; Maturi, Raj K ; Boyer, David S ; Bridges, William Z ; Aziz, Aamir A ; Khanani, Arshad M ; Bagheri, Nika ; Holekamp, Nancy M

Purpose:

To establish the safety, tolerability, pharmacokinetics, and pharmacodynamics of an intravitreal injection of recombinant human complement factor H (CFH), GEM103, in individuals with genetically defined age-related macular degeneration (AMD) and geographic atrophy (GA).

Design:

Phase I single ascending-dose, open-label clinical trial (ClinicalTrials.gov identifier, NCT04246866).

Participants:

Twelve individuals 50 years of age or older with a confirmed diagnosis of foveal GA in the study eye.

Methods:

Participants were assigned to the increasing dose cohorts and received 1 50-μl intravitreal injection of GEM103 at doses of 50 μg/eye, 100 μg/eye, 250 μg/eye, or 500 μg/eye; dose escalation was dependent on the occurrence of dose-limiting toxicities.

Main Outcome Measures:

Safety assessments included ocular and systemic adverse events (AEs), ocular examinations, clinical laboratory and vital signs, and serum antidrug antibody levels. Biomarkers, measured in the aqueous humor (AH), included CFH and complement activation biomarkers factor Ba and complement component 3a.

Results:

No dose-limiting toxicities were reported, enabling escalation to the maximum study dose. No anti-GEM103 antidrug antibodies were detected during the study. Four participants experienced AEs; these were nonserious, mild or moderate in severity, and unrelated to GEM103. The AEs in 2 of these participants were related to the intravitreal injection procedure. No clinically significant ophthalmic changes and no ocular inflammation were observed. Visual acuity was maintained and stable throughout the 8-week follow-up period. No choroidal neovascularization occurred. CFH levels increased in a dose-dependent manner after GEM103 administration with supraphysiological levels observed at week 1; levels were more than baseline for 8 weeks or more in all participants receiving single doses of 100 μg or more. Complement activation biomarkers were reduced 7 days after dose administration.

Conclusions:

A single intravitreal administration of GEM103 (up to 500 μg/eye) was well tolerated in individuals with GA. Of the few mild or moderate AEs reported, none were determined to be related to GEM103. No intraocular inflammation or choroidal neovascularization developed. CFH levels in AH were increased and stable for 8 weeks, with pharmacodynamic data suggesting that GEM103 restored complement regulation. These results support further development in a repeat-dose trial in patients with GA with AMD.

26 May 2020·Veterinary medicine international

An Intranasal Vaccination with a Recombinant Outer Membrane Protein H against Haemorrhagic Septicemia in Swamp Buffaloes

Article

Author: Tankaew, Pallop ; Muangthai, Korkiat ; Rittipornlertrak, Amarin ; Varinrak, Thanya ; Atthikanyaphak, Kheemchompu ; Sthitmatee, Nattawooti ; Nambooppha, Boondarika ; Sawada, Takuo ; Muenthaisong, Anucha

Hemorrhagic septicemia (HS) is an important infectious disease in cattle and buffaloes, caused by Pasteurella multocida B:2 and E:2. The intranasal recombinant OmpH-based vaccine was successfully used to protect dairy cattle from HS in a previous study. Thus, this study aimed to examine the protective ability of that vaccine among buffaloes. Four groups of Thai swamp buffaloes received different vaccines and were labeled as 100 or 200 μg of the rOmpH with CpG-ODN2007, commercial HS bacterin vaccine, and nonvaccinated control groups. Sera and whole blood were collected to examine the antibody levels and cellular immune response using indirect ELISA and MTT assay, respectively. Challenge exposure was performed with virulent P. multocida strain M-1404 serotype B:2 on day 72 of the experiment. The antibody titers to P. multocida among immunized buffaloes were significantly higher than in the control group (p<0.01), especially the 200 μg of the rOmpH group. The stimulation index (SI) of the intranasally vaccinated groups revealed significantly higher levels than the nonvaccinated group (p<0.01), but not different from the intramuscularly commercial HS vaccine. The clinical signs and high fever were observed after challenge exposure in the nonvaccinated group, while it was not observed among the 200 μg of rOmpH immunized buffaloes. The other immunized groups showed partial protection with transient fever. In conclusion, the rOmpH-based intranasal vaccine could elicit protective ability and induce antibody- and cell-mediated immune response against virulent P. multocida strain among swamp buffaloes.

News (Medical) associated with GEM-103

25 Apr 2023

·www.globenewswire.com

4DMT Acquires Complement Pathway Inhibitor Payload for 4D-175 Product Candidate for Geographic Atrophy

4DMT acquires all world-wide rights to short-form human complement factor H (sCFH) from Aevitas Therapeutics, Inc.; technology invented at University of PennsylvaniaAnnounces sCFH as payload for 4D-175 lead product candidate for geographic atrophy (GA); sCFH extensively characterized in 3 genetic mouse models and in non-human primates (NHP)CFH variants with reduced complement inhibitory function are a well-validated genetic risk factor for GA secondary to age-related macular degeneration (AMD), with approximately 75% of AMD patients carrying a high-risk variant of CFH; utilizing a precision medicine approach, this population represents a potential target population for 4D-175Continues expansion of the proprietary R100 retinotropic vector-based large-market ophthalmology portfolio beyond 4D-150 for wet AMD and diabetic macular edema (DME) EMERYVILLE, Calif., April 24, 2023 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, “4DMT”), a clinical-stage biotherapeutics company harnessing the power of directed evolution for genetic medicines targeting large-market diseases, today announced that it acquired the rights and know-how for short-form human complement factor H (sCFH) from Aevitas Therapeutics, Inc. The transgene encoding sCFH, a shortened and optimized form of a natural inhibitor of the inflammatory complement pathway invented at the University of Pennsylvania, will be combined with 4DMT’s proprietary retinotropic R100 vector to engineer the product candidate 4D-175 for treatment of GA secondary to AMD. Geographic atrophy is a highly prevalent disease with a significant unmet medical need. According to published estimates, there are over one million individuals with GA in the U.S. alone as of 2022. The first treatment for GA, complement inhibitor pegcetacoplan injection, was approved in the U.S. in February 2023 and is administered by intravitreal (IVT) injection once every 25 to 60 days. Similar treatment regimens with anti-VEGF agents for neovascular (wet) AMD have proven difficult to maintain. Challenges in adhering to monthly or every-other-month treatment for wet AMD can lead to suboptimal clinical outcomes, suggesting the same may be encountered in the treatment of GA. Thus, a treatment that achieves consistent expression of a therapeutic could lead to more optimal clinical outcomes. 4D-175 is designed to achieve continuous expression of sCFH in the retina from a single injection in order to inhibit the inflammatory complement pathway in patients with GA without requiring repeated injections. Complement Factor H (CFH) is a master regulator of the complement system, functioning as a natural inhibitor of the alternative complement pathway. Dysregulation of the complement system can lead to autoimmune and inflammatory diseases, including GA. Mutations in the gene encoding CFH are among the strongest genetic risk factors for AMD including GA, with approximately 75% of patients carrying a high-risk variant of CFH with reduced complement inhibitory function, leading to complement pathway hyperactivity. sCFH is an engineered and optimized version of CFH that can fit into AAV vectors with robust expression and full functionality confirmed in human cells in vitro, and in multiple preclinical animal models and species in vivo. The construct was co-invented by Wenchao Song, Ph.D., Professor of Pharmacology at the Perelman School of Medicine at the University of Pennsylvania. Dr. Song has extensive experience researching complement-mediated inflammatory, autoimmune, and thrombotic vasculopathy disorders. Restoring CFH function using sCFH protein could restore normal complement regulation and reduce retinal injury that manifests as progressive GA. Preclinical proof-of-concept for this approach using 1) human sCFH delivered systemically using an adeno associated virus (AAV) in a mouse model of atypical hemolytic uremic syndrome (aHUS) and 2) a mouse version of sCFH delivered using an AAV in mouse models of C3 glomerulopathy and aHUS each demonstrated recovery from complement dysregulation, reduced organ damage, and improved survival. “The potential of delivering sCFH with a clinically-validated retinotropic AAV vector in R100 for complement-mediated ophthalmologic diseases is an exciting step in advancing meaningful therapies toward the clinic,” said Dr. Song. “I look forward to working with the 4DMT team to continue the development of sCFH to potentially treat GA and other diseases.” “We are pleased to add an innovative and differentiated preclinical GA product candidate into our large market ophthalmology portfolio, which leverages our clinically-validated R100 retinotropic vector,” said David Kirn, M.D., Co-founder and Chief Executive Officer of 4DMT. “This represents continued value generation from our robust product design and development engine to leverage the vector modularity of our platform in the ophthalmology therapeutic area.” “Providing patients with a low-dose, safe and tolerable long-duration treatment option with the potential to preserve vision in patients with GA would be a tremendous breakthrough,” said Robert Kim, M.D., Chief Medical Officer of 4DMT. “We are working relentlessly to leverage our existing clinical, nonclinical, and CMC experience with the R100 vector in three different patient populations to rapidly bring this important product candidate to the clinic.” About 4DMT 4DMT is a clinical-stage biotherapeutics company harnessing the power of directed evolution for genetic medicines targeting large market diseases. 4DMT seeks to unlock the full potential of genetic medicines using its proprietary invention platform, Therapeutic Vector Evolution, which combines the power of the Nobel Prize-winning technology, directed evolution, with approximately one billion synthetic AAV capsid-derived sequences to invent customized and evolved vectors for use in our product candidates. All of our vectors are proprietary to 4DMT and were invented at 4DMT, including the vectors utilized in our clinical-stage and preclinical pipeline product candidates: R100, A101, and C102. The Company is initially focused on five clinical-stage product candidates in three therapeutic areas for both rare and large market diseases: ophthalmology, pulmonology, and cardiology (Fabry disease cardiomyopathy). The 4DMT customized and evolved vectors were invented with the goal of being delivered at relatively low doses through clinically routine, well-tolerated, and minimally invasive routes of administration, transducing diseased cells in target tissues efficiently, having reduced immunogenicity and, where relevant, having resistance to pre-existing antibodies. 4DMT is currently advancing five product candidates in clinical development: 4D-150 for wet AMD and DME, 4D-710 for cystic fibrosis lung disease, 4D-310 for Fabry disease cardiomyopathy, 4D-125 for XLRP, and 4D-110 for choroideremia. The 4D preclinical product candidates in development are: 4D-175 for geographic atrophy and 4D-725 for AATLD. 4D-150, 4D-710, 4D-310, 4D-125, and 4D-110 are 4DMT’s product candidates in clinical development and have not yet been approved for marketing by the US FDA or any other regulatory authority. No representation is made as to the safety or effectiveness of 4D-150, 4D-710, 4D-310, 4D-125, or 4D-110 for the therapeutic uses for which they are being studied. 4D Molecular Therapeutics™, 4DMT™, Therapeutic Vector Evolution™, and the 4DMT logo are trademarks of 4DMT. The laboratory of Dr. Song at the University of Pennsylvania has received sponsored research funding from Aevitas Therapeutics. Penn and Dr. Song have either received, or may receive in the future, financial consideration related to the licensing of certain Penn intellectual property to 4DMT. Dr. Song holds an equity stake in Aevitas, is a scientific founder of Aevitas and is a member of their Scientific Advisory Board. Forward Looking Statements: This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements regarding the therapeutic potential, and clinical benefits, as well as the development plans and related timing for the clinical development of 4D-175. The words "may," “might,” "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," “expect,” "estimate," “seek,” "predict," “future,” "project," "potential," "continue," "target" and similar words or expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including risks and uncertainties that are described in greater detail in the section entitled "Risk Factors" in 4D Molecular Therapeutics’ most recent Annual Report on Form 10-K, as well as any subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent 4D Molecular Therapeutics' views only as of today and should not be relied upon as representing its views as of any subsequent date. 4D Molecular Therapeutics explicitly disclaims any obligation to update any forward-looking statements. No representations or warranties (expressed or implied) are made about the accuracy of any such forward looking statements. Contacts: Media: Katherine SmithEvoke CanaleKatherine.Smith@evokegroup.com Investors: Julian PeiHead of Investor Relations and Corporate Financejpei@4dmt.com267-644-5097

Drug Approval

10 Aug 2022

·www.biopharmadive.com

Gemini’s fall gives Disc a way around biotech’s IPO slump

Dive Brief:Disc Medicine, a privately held startup specializing in drugs for blood disorders, announced Wednesday it will go public through a reverse merger with struggling biotechnology company Gemini Therapeutics.The new company will use Discs name, be run by its existing management team and advance a portfolio of medicines led by a candidate thats newly in Phase 2 testing. Disc shareholders will own 72% of the company, while existing Gemini stockholders will hold the remaining 28%.In a challenging year for biotechs planning to go public, the reverse merger gives Disc an alternative route to Wall Street, while a concurrent round of financing hands it access to new funds.Dive Insight:Current market conditions are preventing many private biotech companies from going public, but where there's a will, there's a way. The reverse merger will give Watertown, Mass.-based Disc an infusion of much-needed cash while allowing the troubled Gemini to capitalize on the value of its public listing.By the time the companies close the deal in the last quarter of 2022, there will be approximately $92 million left in Gemini's coffers, said Jonathan Yu, Discs chief business officer.Combined with roughly $54 million in new financing from investors including OrbiMed, Atlas Venture and 5 AM Ventures, plus whats left of a $90 million round from 2021, Disc will have $175 million available by the end of the year, enough to keep the company afloat until 2025.Disc CEO John Quisel said the company decided against waiting for the right time to file for an initial public offering once the offer from Gemini was on the table.We can now control our future and ensure that our molecules are able to complete their clinical course, Quisel said.Disc Medicines portfolio includes bitopertin, an experimental drug licensed from Roche that turned up poor results against psychiatric disorders like schizophrenia, but showed potential for treating certain rare genetic blood disorders. Bitopertin is now in Phase 2 clinical testing for erythropoietic porphyria, a potentially fatal inherited condition, with Disc announcing the trials initiation on Wednesday.It's also working on an antibody drug acquired from AbbVie and designed to treat some forms of anemia. One Phase 1b/2 trial evaluating the drug in myelofibrosis patients with anemia is already underway. Disc plans to start a second study in patients with chronic kidney disease later this year.Funding those clinical trials requires a lot of capital, and thats where the funds from Gemini come in.Gemini went public five years after its launch, via an October 2020 merger with a special purpose acquisition company created by investment firm Foresite Capital. Shares began trading in February 2021. The company was working on GEM103, a candidate to treat age-related macular degeneration, among other drug prospects.But Gemini fell on hard times during the downturn. In October, it cut 20% of its workforce and announced it would focus exclusively on late-stage development of GEM103, ending its early drug research.That trial never began, however. A strategic review was launched in January and a month later, Gemini's board of directors appointed a new CEO. The company then let go of 80% of its remaining employees and terminated its work on GEM103.The new board will include eight directors from Disc and one from Gemini.Over the past few years, we've learned that there's a lot of uncertainty in the world, Quisel said. This transaction presenting itself now is a great opportunity for us. '

AntibodyIPOAcquisition

15 Jul 2022

·www.sciencedaily.com

Opening new doors: First synthetic mechanosensitive potassium channel

Intrigued by the properties of ion channel proteins commonly observed in cells, researchers have developed the first synthetic mechanosensitive potassium channel using a newly developed aromatic fluorinated amphiphilic cyclophane. Displaying both 'stimuli responsiveness' and 'selective ion transport' abilities, their new ion channel could open new doors for the future therapeutic and industrial usage of synthetic mechanosensitive channels. Intrigued by the properties of ion channel proteins commonly observed in cells, Tokyo Tech researchers have developed the first synthetic mechanosensitive potassium channel using a newly developed aromatic fluorinated amphiphilic cyclophane. Displaying both "stimuli responsiveness" and "selective ion transport" abilities, their new ion channel could open new doors for the future therapeutic and industrial usage of synthetic mechanosensitive channels. Nature inspires humankind in a myriad of ways. Take, for instance, "stimuli-responsive" ion transport channel proteins. These proteins are found embedded in cell membranes and respond to a variety of external stimuli, including light, pH, and mechanical force. Given their crucial role in several biological processes, researchers have attempted to synthesize the artificial versions of these channel proteins for use in therapeutic and industrial settings. However, success in synthesizing them has been elusive. The complex structural requirements for stimuli responsiveness and specific ion transport properties have been identified as the major impediment in their synthesis. Overcoming these difficulties, researchers from Tokyo Institute of Technology (Tokyo Tech), led by Assistant Professor Kohei Sato and Full Professor Kazushi Kinbara, have recently developed the first synthetic mechanosensitive (responsive to mechanical force) channel with potassium ion selectivity. Their findings are published in the Journal of the American Chemical Society. Talking about the study, Assist. Prof. Sato and Prof. Kinbara, affiliated with the School of Life Science and Technology at Tokyo Institute of Technology (Tokyo Tech), say, "With our experience in designing multiblock amphiphiles which self-assemble to form supramolecular ion channels, we hypothesized that linear amphiphiles were not suitable for transporting specific ions; hence, we attempted structural modifications to incorporate both stimuli responsiveness and ion selectivity." As mentioned by Assist. Prof. Sato and Prof. Kinbara, the researchers tweaked the structure of a complex organic molecule known as a multiblock amphiphile to incorporate a perfluorinated aromatic unit. The resulting structure, a fluorinated amphiphilic cyclophane, contained hydrophobic perfluorinated oligo(phenylene-ethynylene) units and hydrophilic octa(ethylene glycol) linkers. The researchers also designed one partially fluorinated and one nonfluorinated amphiphilic cyclophane for investigating the impact of aromatic fluorination. Microscopy revealed that both the perfluorinated cyclophane, named CFF, and the partially fluorinated cyclophane, named CFH, could get incorporated in the lipid bilayer membrane, while the nonfluorinated cyclophane could not. The researchers then analyzed the ion transport property, stimuli responsiveness, and potassium ion selectivity of CFF and CFH using conductance measurements, fluorescence assays, and computational studies. They identified that both CFF and CFH self-assembled in the bilayer membrane to form supramolecular ion channels. Moreover, the flow of current across the membrane confirmed the transmembrane ion transport property of both CFF and CFH, more efficient and pronounced in CFF. Changes in the current flow on applying membrane tension further confirmed the stimuli responsiveness of the channels formed by CFF and CFH. The ion transport property of CFF was affected significantly, while it did not change much for CFH. Assist. Prof. Sato, Prof. Kinbara, and their team attribute these variations to the differential interaction of the aromatic units of CFH and CFF within the membrane. Lastly, fluorescence assay revealed highest permeability of CFF for potassium ions compared to other alkali metal cations. The team found that the higher affinity of potassium ions for the fluorine atoms in the core of the structure was responsible for this phenomenon. Commenting on these findings, Assist. Prof. Sato and Prof. Kinbara say, "The fact that a supramolecular ion channel formed by CFF possesses such stimuli responsiveness and potassium ion selectivity is not only intriguing, but also strikingly similar to the mechanosensitive channels found in mammalian neurons." With this demonstration, possibilities such as the development of therapies for ion-channel related diseases, manipulation of important biological processes, and development of industrial material purification technologies are already in sight!

100 Deals associated with GEM-103

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Wet age-related macular degeneration	Phase 2	US	Gemini Therapeutics, Inc.	29 Dec 2020
dry age-related macular degeneration	Phase 2	US	Gemini Therapeutics, Inc.	30 Jul 2020
Geographic Atrophy	Phase 2	US	Gemini Therapeutics, Inc.	30 Jul 2020

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04684394 (CTgov)	Phase 2	Wet age-related macular degeneration	50	aflibercept+GEM103 (SoC + GEM103)	vokadlgqgj(ztlrnfvztr) = lpfowtdheb cwcpmharim (xddwovlyxm, bqpozlsado - gzzdbejzva) View more	-	31 Oct 2022
				Sham (SoC + Sham)	vokadlgqgj(ztlrnfvztr) = kldfqnbkwd cwcpmharim (xddwovlyxm, plwwxztchp - hekxqptkbq) View more
PO329 (AAO2021)	Phase 2	Geographic Atrophy complement factor H (CFH) levels \| PD biomarkers in AH	62	GEM103 at 250 µg	jjlzupnnyl(hosloolboa) = ugmgueulay rihnviutfz (jtawvykibb, 18.92) View more	Positive	13 Nov 2021
				GEM103 at 500 µg	jjlzupnnyl(hosloolboa) = dezdvylped rihnviutfz (jtawvykibb, 18.92) View more

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