Disc Medicine Announces Several Presentations Across Hematology Portfolio at the 64th American Society of Hematology Annual Meeting - PR Newswire

1 year ago 48

, /PRNewswire/ -- Disc Medicine, a clinical-stage biopharmaceutical institution focused connected the discovery, development, and commercialization of caller treatments for patients surviving with superior hematologic diseases, presented 5 posters spanning respective of its hematology programs astatine the 64^th American Society of Hematology (ASH) Annual Meeting and Exposition held successful New Orleans, LA.

"Disc Medicine continues to marque sizeable advancement towards the improvement of perchance first-in-class therapeutic candidates for hematologic disorders," said John Quisel, J.D., Ph.D., Chief Executive Officer astatine Disc Medicine. "The 5 presentations astatine the ASH Annual Meeting show the singular enactment of our squad to make caller candidates that are designed to people cardinal pathways with validated roles successful reddish humor compartment biology."

A transcript of each poster presumption from the ASH Annual Meeting is disposable connected Disc's website.

Bitopertin: Bitopertin is an investigational, orally administered inhibitor of glycine transporter 1, GlyT1, that is designed to inhibit heme biosynthesis, with 2 Phase 2 trials presently ongoing successful erythropoietic protoporphyria (EPP), a illness characterized by utmost phototoxic reactions and liver illness caused by an accumulation of the heme metabolite metal-free PPIX.

Poster 2346: BEACON: A Phase 2, Randomized, Open Label Study of Bitopertin to Evaluate the Safety, Tolerability, Efficacy, and Protoporphyrin IX Concentrations successful Participants with Erythropoietic Protoporphyria (EPP)

BEACON Phase 2 survey is an ongoing randomized, open-label, aggregate dose objective proceedings being conducted successful Australia, designed to measure the safety, tolerability, and efficacy of bitopertin successful patients with EPP oregon X-linked protoporphyria (XLP)
Patients volition beryllium stratified by mean clip to prodrome past randomized into 2 open-label parallel arms of 20mg (<30 minutes to prodrome) and 60mg (>30 minutes to prodrome) oral bitopertin erstwhile regular for 24 weeks
Primary endpoint is the percent alteration from baseline successful metal-free protoporphyrin IX (PPIX) levels
Key secondary endpoint is full hours of sunlight vulnerability from 10:00 americium to 6:00 pm connected days with nary pain, and different secondary endpoints see the pharmacokinetic (PK) profile, and the information and tolerability of bitopertin
Upon completion of the 24-week attraction period, patients person the enactment of continuing successful an open-label hold of the study

Poster 3661: Bitopertin, a Selective Glycine Transporter 1 Inhibitor, Reduced PPIX Level and Improved Liver Fibrosis successful a Mouse Model of Erythropoietic Protoporphyria (EPP)

Data demonstrated that bitopertin, an investigational, orally disposable selective inhibitor of GlyT1, tin trim PPIX accumulation successful humor and trim cholestasis and fibrosis successful the liver of an EPP rodent model
Mice that received 100 ppm and 200 ppm bitopertin exhibited a 31% and 49% simplification successful escaped PPIX successful blood, respectively
Bitopertin attraction led to 51% and 45% reductions successful PPIX attraction successful the livers of EPP mice astatine 100 ppm and 200 ppm, respectively
Addition of bitopertin to the fare of EPP mice reduced the incidence of ductular absorption and the severity of liver fibrosis, with 60% of the power radical exhibiting ductular absorption arsenic compared to 30% of the 100 ppm bitopertin radical and 10% of the 200 ppm bitopertin radical arsenic evaluated done histopathological analysis
We judge these information suggest that bitopertin whitethorn beryllium disease-modifying and whitethorn beryllium effectual successful treating the photosensitivity and modifying the hepatoxicity successful EPP patients

DISC-0974: DISC-0974 is an investigational monoclonal antibody (mAb) targeting a bony morphogenetic macromolecule (BMP)-signaling co-receptor called hemojuvelin (HJV) and is designed to suppress hepcidin accumulation and summation serum robust levels successful patients suffering from anemia of inflammation.

Poster 2339: DISC-0974, an Anti-Hemojuvelin Antibody, Reduces Hepcidin and Mobilizes Iron successful Healthy Volunteers

A treble blind, placebo-controlled Phase 1a survey successful steadfast volunteers, evaluated azygous ascending doses of DISC-0974 astatine 7mg and 28mg IV and 14mg, 28mg, and 56mg SC
DISC-0974 demonstrated favorable PK profiles, and important aspects of the compound's pharmacokinetic (PK)/pharmacodynamics (PD) narration were observed
Demonstrated tolerability, with lone Grade 1 adverse events observed crossed each dose levels
DISC-0974 was shown to little serum hepcidin-25 and summation serum robust successful a dose-dependent manner.
56mg SC dose radical (N=6) besides showed an summation successful reddish humor cells and hemoglobin compared to placebo
A survey of once-monthly dosing of DISC-0974 is ongoing successful myelofibrosis and anemia patients (NCT05320198) and studies are planned successful different diseases with anemia of inflammation, specified arsenic chronic kidney illness (CKD)

Poster 3641: DISC-0974, an Anti-Hemojuvelin (HJV) Monoclonal Antibody, Reduced Hepcidin and Improved Anemia successful a Rat Model of Chronic Kidney Disease

Treatment of adenine-induced rat models of CKD with DISC-0974 resulted successful a simplification successful HAMP cistron look successful the liver arsenic measured astatine the extremity of the study, accordant with the projected mechanics of enactment of blocking the enactment of the BMP/BMPR/HJV complex
DISC-0974 led to a simplification successful serum hepcidin levels, accrued robust availability, and substantially prevented the simplification successful hemoglobin that is seen successful animals with renal impairment induced by adenine
Study provides preclinical impervious of conception for the improvement of DISC-0974 for the attraction of patients with CKD anemia and Disc is readying a Phase 2 survey of DISC-0974 successful CKD anemia

DISC-0998: DISC-0998 is an investigational, potent and highly selective HJV mAb engineered with the mutation operation of T250Q/M429L (QL-mutation) successful the Fc region, which is designed to change binding to the FcRn receptor and summation PK half-life.

Poster 3657: Preclinical Pharmacokinetics and Pharmacodynamics of DISC-0998, a Humanized Anti-Hemojuvelin (HJV) Monoclonal Antibody to Suppress the Production of Hepcidin

Study evaluated the PK/PD relationships of DISC-0998 with hepcidin, serum iron, and transferrin saturation (TSAT) successful antheral cynomolgus monkeys
Following azygous SC oregon IV dose, DISC-0998 exhibited debased clearance (SC CL/F 0.14 - 0.83 mL/hr/kg, IV CL 0.14 mL/hr/kg), tiny measurement of organisation (Vz 50 -104 mL/kg), and nonlinear PK arsenic expected for a mAb
Compared to DISC-0974, DISC-0998 clearance was 33% lower, and half-life (t_1/2) was implicit 2 times longer
Findings enactment further improvement of DISC-0998 for disorders related to anemia of inflammation, with the imaginable for little predominant dosing compared to DISC-0974

About Disc Medicine

Disc Medicine is simply a clinical-stage biopharmaceutical institution that is dedicated to transforming the lives of patients with hematologic disorders. We are gathering a portfolio of innovative, perchance first-in-class therapeutic candidates that are designed to impact cardinal pathways of reddish humor compartment biology. We are committed to processing treatments that empower and bring anticipation to the galore patients who endure from hematologic diseases. For much information, delight sojourn www.discmedicine.com.

On August 10, 2022, Gemini Therapeutics, Inc. (Nasdaq: GMTX) ("Gemini") and Disc Medicine, Inc. ("Disc"), announced that they person entered into a definitive merger statement to harvester the companies successful an all-stock transaction. The combined institution volition absorption connected advancing Disc's pipeline of hematology programs, including aggregate objective trials for its clinical-stage programs bitopertin and DISC-0974. Upon shareholder approval, the combined institution is expected to run nether the sanction Disc Medicine, Inc. and commercialized connected the Nasdaq Global Market nether the ticker awesome IRON. The merger and related financing are expected to adjacent successful the 4th fourth of 2022. For much accusation visit: https://www.discmedicine.com/news/gemini-therapeutics-and-disc-medicine-announce-merger-agreement/.

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