TARC

Apogee Therapeutics Announces First Participants Dosed in Phase 1 Trial of APG808, its Novel Half-life Extended IL-4Rα Antibody for the Treatment of Chronic Obstructive Pulmonary Disease (COPD) and Other Inflammatory Diseases

Retrieved on: 
Monday, March 25, 2024
I&I, TARC, Atopic dermatitis, Disease, Half-life, Patient, SAN, Heel, IND, Respiratory disease, Asthma, SQ, Clinical trial, Therapy, Safety, Pharmacokinetics, Engineering, Pharmaceutical industry

SAN FRANCISCO and WALTHAM, Mass., March 25, 2024 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc. (Nasdaq: APGE), a clinical-stage biotechnology company advancing differentiated biologics for the treatment of atopic dermatitis (AD), COPD, asthma and other inflammatory and immunology (I&I) indications, today announced that it has initiated dosing of healthy volunteers in its first clinical trial for APG808, a novel subcutaneous (SQ) extended half-life monoclonal antibody (mAb) targeting IL-4Rα, which is being developed as a treatment for people living with moderate-to-severe COPD, asthma and other I&I diseases.

Key Points: 
  • COPD is a progressive respiratory disease that is estimated to affect approximately 10 percent of the global population 40 years of age and older.
  • Despite recent advancements in COPD treatment, a significant number of people continue to suffer and die from the disease.
  • The APG808 Phase 1 trial is designed as a double-blind, placebo-controlled, first-in-human, single-ascending dose trial in healthy volunteers.
  • Importantly, this points to potentially less frequent dosing for patients with COPD, which could significantly improve quality of life.”

Press Release: New Phase 2b results for amlitelimab support potential for best-in-class maintenance of response in atopic dermatitis

Retrieved on: 
Monday, March 11, 2024
Eosinophil, Fever, Week, Headache, OX40L, Conjunctivitis, Scleroderma, Teaching hospital, Atopic dermatitis, Upper respiratory tract infection, Part, Asthma, TARC, Conference, AAD, Safety, Biomarker, Part Two, Hidradenitis suppurativa, IGA, Patient, Inflammation, Chills, Moa, Serum, American Academy, Pharmaceutical industry

The safety profile was consistent with Part 1 of the study with amlitelimab being well-tolerated and no new safety concerns identified.

Key Points: 
  • The safety profile was consistent with Part 1 of the study with amlitelimab being well-tolerated and no new safety concerns identified.
  • Overall rates of treatment-emergent adverse events (TEAEs) were 69.8% for continued amlitelimab treatment, 71.9% for the amlitelimab withdrawal-arm and 66.7% for placebo.
  • TEAEs more commonly observed included headache (11.6% amlitelimab continuation, 3.9% amlitelimab withdrawal, 6.7% placebo), upper respiratory tract infection (9.3% amlitelimab continuation, 5.5% amlitelimab withdrawal, 20% placebo).
  • Amlitelimab is currently under clinical investigation, and its safety and efficacy have not been evaluated by any regulatory authority.

Apogee Therapeutics Provides Pipeline Progress and Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Tuesday, March 5, 2024
SQ, PD, Injection, I&I, Research, OX40L, Inflammation, Atopic dermatitis, Growth, Asthma, TARC, Chronic obstructive pulmonary disease, IPO, Interim, Safety, Therapy, Pharmacokinetics, Patient, Clinical trial, Half-life, G&A, Pharmaceutical industry

SAN FRANCISCO and WALTHAM, Mass., March 05, 2024 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc. (Nasdaq: APGE), a clinical-stage biotechnology company advancing differentiated biologics for the treatment of atopic dermatitis (AD), chronic obstructive pulmonary disease (COPD), asthma and other inflammatory and immunology (I&I) indications, today reported pipeline highlights and fourth quarter and full year 2023 financial results.

Key Points: 
  • “2023 was a momentous year for Apogee with the completion of a successful IPO, initiation of our first clinical program of APG777 in healthy volunteers and the nomination of our second pipeline candidate, APG808,” said Michael Henderson, M.D., Chief Executive Officer of Apogee.
  • Cash Position: Cash, cash equivalents and marketable securities were $395.5 million as of December 31, 2023, compared to $151.9 million as of December 31, 2022.
  • Based on current operating plans, Apogee expects its existing cash, cash equivalents and marketable securities will enable the company to fund its operating expenses into 4Q 2026.
  • Net loss increased primarily as a result of higher R&D and G&A operating expenses as described above, partially offset by higher interest income.

Apogee Announces Positive Interim Results from Phase 1 Healthy Volunteer Trial for APG777, its Novel Half-Life Extended Anti-IL-13 Antibody for the Treatment for Atopic Dermatitis and Other Inflammatory Diseases, Exceeding its Trial Objectives Ahead of Sc

Retrieved on: 
Tuesday, March 5, 2024
Paragon, Well, SAD, PD, Injection, I&I, Waldman, Headache, Inflammation, Quality of life, Management, Atopic dermatitis, Asthma, TARC, AUC, Volunteering, Cmax, Chronic obstructive pulmonary disease, Outline of health sciences, Safety, Biomarker, Therapy, CQD, Chronic pain, Immunology, IGA, Webcast, Sleep, Patient, MPH, Half-life, Serum, Pharmaceutical industry

Based on these data, the company plans to initiate a randomized, placebo-controlled, Phase 2 clinical trial in patients with moderate-to-severe AD in the first half of 2024 ahead of schedule.

Key Points: 
  • Based on these data, the company plans to initiate a randomized, placebo-controlled, Phase 2 clinical trial in patients with moderate-to-severe AD in the first half of 2024 ahead of schedule.
  • At Apogee, we refuse to stop at good enough and are dedicated to advancing innovative solutions for patients.
  • The Phase 1 trial is a first-in-human, randomized, double-blind, placebo-controlled study designed to evaluate safety and PK of APG777 in healthy volunteers.
  • A live webcast of the call will be available on the Investor Relations page of Apogee’s website at https://investors.apogeetherapeutics.com/news-events/events .

Apogee Highlights Corporate Progress and Reports Third Quarter 2023 Financial Results

Retrieved on: 
Monday, November 13, 2023
European Academy of Management, Safety, SAN, General counsel, Research and development, Therapy, IND, Initial public offering, Exercise, Clinical trial, Administration, Aulus Cornelius Cossus Arvina, Patient, TARC, G&A, Pharmacokinetics, Atopic dermatitis, Conference, IPO, Half-life, R, Growth, Chronic obstructive pulmonary disease, Congress, Health, I&I, Asthma, Inflammation, Vaccine, Pharmaceutical industry, COPD, Apsis, Venereology, Dermatology

SAN FRANCISCO and WALTHAM, Mass., Nov. 13, 2023 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc. (Nasdaq: APGE), a clinical-stage biotechnology company advancing differentiated biologics for the treatment of atopic dermatitis (AD), asthma, chronic obstructive pulmonary disease (COPD) and other inflammatory and immunology (I&I) indications, today provided business updates and reported third quarter 2023 financial results.

Key Points: 
  • “I am proud of our team’s execution during the third quarter and 2023 overall.
  • Research & Development (R&D) Expenses: R&D expenses for the third quarter of 2023 were $17.1 million, compared to $9.9 million for the third quarter of 2022.
  • General and Administrative (G&A) Expenses: G&A expenses for the third quarter of 2023 were $7.2 million, compared to $0.6 million for the third quarter of 2022.
  • Net Loss: Net loss for the third quarter of 2023 was $20.8 million, compared to the net loss for the third quarter of 2022 which was $19.7 million.

ASLAN Pharmaceuticals Presents New Data on Eblasakimab and Farudodstat in Two Late-Breaking Presentations at the 1st International Societies for Investigative Dermatology Meeting

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Monday, May 15, 2023
Learning, Hair, IL-12, ISID, ASLN, Research fellow, TARC, HF, DHODH, MHC, HFS, IP-10, Atopic dermatitis, Research, Inflammation, IP, Publication, Associate, Immune privilege, II, IL-2, Alopecia areata, Organization, Patient, International Society for Traumatic Stress Studies, SAN, Autoimmune disease, GM-CSF, Epithelium, MHC-II, Cytokine, AD, T helper cell, Johns Hopkins School of Medicine, Vaccine, Pharmaceutical industry, Dermatology, TH1, AA

“This late-breaking data offers new and important insights into the novel mechanisms of eblasakimab and farudodstat for atopic dermatitis (AD) and alopecia areata (AA) respectively," said Dr Ferda Cevikbas, Head of Translational Science at ASLAN Pharmaceuticals.

Key Points: 
  • “This late-breaking data offers new and important insights into the novel mechanisms of eblasakimab and farudodstat for atopic dermatitis (AD) and alopecia areata (AA) respectively," said Dr Ferda Cevikbas, Head of Translational Science at ASLAN Pharmaceuticals.
  • “Furthermore, data from an ex vivo human AA disease model demonstrates the potential for farudodstat to protect against immune privilege collapse in AA.
  • This study investigated whether farudodstat, a DHODH inhibitor, has potential in the treatment of AA using an innovative ex vivo model for AA.
  • Together, the findings highlight the potential for farudodstat as a novel therapy for AA.

ASLAN Pharmaceuticals Presents New Data on Eblasakimab in Multiple Posters at the 31st Annual European Academy of Dermatology and Venereology (EADV) Congress

Retrieved on: 
Wednesday, September 7, 2022
NASDAQ, Immunoglobulin E, Itch, Sleep, Serum, Congress, POC, TARC, ASLN, GLOBE, Surround optical-fiber immunoassay, European Academy of Allergy and Clinical Immunology, Atopy, Atopic dermatitis, Biomarker, AD, AD1, Patient, LDH, Vaccine, Pharmaceutical industry, Venereology, Dermatology

Three posters are being presented as e-posters throughout the duration of the congress from September 7 to 10, 2022.

Key Points: 
  • Three posters are being presented as e-posters throughout the duration of the congress from September 7 to 10, 2022.
  • Collectively, the data being presented at EADV gives us great confidence to continue investigating eblaskaimabs role in AD and other indications in the future.
  • Signaling through the Type 2 receptor induces expression of a multitude of marker molecules, correlating with disease severity.
  • The poster shows results of patient samples from the proof-of-concept (PoC) trial of eblasakimab in adults with moderate-to-severe atopic dermatitis.

Non-invasive skin immune biomarker test helps predict development of eczema in babies, new study presented at the EADV Congress finds

Retrieved on: 
Tuesday, September 6, 2022
University, Bispebjerg Hospital, Shoulder, Dermatitis, Disease, Skin, Barrier, BABY, TARC, Association, European Academy of Allergy and Clinical Immunology, IT University of Copenhagen, Immune system, Population, Biomarker, Risk, Congress, Life, Journal of the European Academy of Dermatology and Venereology, Pharmaceutical industry, Vaccine, Medical device, Venereology, Dermatology

MILAN, Sept. 6, 2022 /PRNewswire/ -- Researchers have identified an immune biomarker in newborns that can predict the subsequent onset and severity of paediatric atopic eczema, a new study presented at the 31st European Academy of Dermatology and Venereology (EADV) Congress has shown.

Key Points: 
  • MILAN, Sept. 6, 2022 /PRNewswire/ -- Researchers have identified an immune biomarker in newborns that can predict the subsequent onset and severity of paediatric atopic eczema, a new study presented at the 31st European Academy of Dermatology and Venereology (EADV) Congress has shown.
  • The study found a positive association between the level of TARC and the severity of eczema.
  • The strips were analysed for immune biomarkers and babies were followed up for the next 2 years.
  • This provides a window of opportunity to develop targeted trials and prevent cases of eczema from occurring", concluded Dr Anne-Sofie Halling.

Non-invasive skin immune biomarker test helps predict development of eczema in babies, new study presented at the EADV Congress finds

Retrieved on: 
Tuesday, September 6, 2022
University, Bispebjerg Hospital, Shoulder, Dermatitis, Disease, Skin, Barrier, BABY, TARC, Association, European Academy of Allergy and Clinical Immunology, IT University of Copenhagen, Immune system, Population, Biomarker, Risk, Congress, Life, Journal of the European Academy of Dermatology and Venereology, Pharmaceutical industry, Vaccine, Medical device, Venereology, Dermatology

MILAN, Sept. 6, 2022 /PRNewswire/ -- Researchers have identified an immune biomarker in newborns that can predict the subsequent onset and severity of paediatric atopic eczema, a new study presented at the 31st European Academy of Dermatology and Venereology (EADV) Congress has shown.

Key Points: 
  • MILAN, Sept. 6, 2022 /PRNewswire/ -- Researchers have identified an immune biomarker in newborns that can predict the subsequent onset and severity of paediatric atopic eczema, a new study presented at the 31st European Academy of Dermatology and Venereology (EADV) Congress has shown.
  • The study found a positive association between the level of TARC and the severity of eczema.
  • The strips were analysed for immune biomarkers and babies were followed up for the next 2 years.
  • This provides a window of opportunity to develop targeted trials and prevent cases of eczema from occurring", concluded Dr Anne-Sofie Halling.

DermTech Presents New Research Differentiating Atopic Dermatitis and Psoriasis at the Society for Investigative Dermatology’s Annual Meeting

Retrieved on: 
Wednesday, May 18, 2022
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Medical Devices, Genetics, Physician, Psoriasis, Population, Medicine, Private Securities Litigation Reform Act, Lecture, IPC, Overalls, U.S. Securities and Exchange Commission, Dermatology, Skin, Smart, Patient, NASDAQ, Solution, SID, Decision-making, Clinical trial, CXCL9, Research, Medicare, Method, Howell, Registry, RNA, Biomarker, Genomics, NOS2, Inflammation, Adoption, TARC, Precision medicine, Society, Security (finance), SEC, Annual report, Atopic dermatitis, Medical imaging, Pharmaceutical industry

Michael Howell, Ph.D., chief scientific officer at DermTech, presented new research that enables the differentiation of the inflammatory signatures of atopic dermatitis from psoriasis in potential clinical trial participants.

Key Points: 
  • Michael Howell, Ph.D., chief scientific officer at DermTech, presented new research that enables the differentiation of the inflammatory signatures of atopic dermatitis from psoriasis in potential clinical trial participants.
  • Titled A Novel Expression Based, Non-Invasive Method to Differentiate Atopic Dermatitis and Psoriasis, the presentation focused on the viability of conducting non-invasive skin sampling with the DermTech Smart Sticker to differentiate atopic dermatitis from psoriasis.
  • DermTech collected epidermal skin samples from patients with moderate to severe atopic dermatitis and psoriasis for this research study.
  • Using a machine-learning approach, DermTech identified a unique ratio that stratified patients into atopic dermatitis versus psoriasis.