Northstrive Biosciences Announces Positive FDA Response Supporting A Submission of IND for a Phase 2 Clinical Trial for EL-22 in Combination with GLP-1 Receptor Agonist for Obesity Treatment
Northstrive Biosciences, a subsidiary of PMGC Holdings (NASDAQ: ELAB), received positive FDA preliminary responses regarding their pre-IND meeting for EL-22, a novel engineered probiotic designed for obesity treatment in combination with GLP-1 receptor agonists.
The FDA's feedback supported that:
- Pharmacology studies demonstrate EL-22 activity
- Nonclinical studies adequately support safety and activity in overweight/obese populations
- Phase 1 study data and nonclinical studies appear sufficient for initiating Phase 2 trials
EL-22 targets the myostatin pathway to support muscle health during weight loss treatments. The company plans to file an IND application in 2025 to initiate Phase 2 clinical trials. Previous Phase 1 trials in South Korea showed the treatment was generally well-tolerated and safe in healthy volunteers.
Northstrive Biosciences, una filiale di PMGC Holdings (NASDAQ: ELAB), ha ricevuto risposte preliminari positive dalla FDA riguardo al loro incontro pre-IND per EL-22, un nuovo probiotico ingegnerizzato progettato per il trattamento dell'obesità in combinazione con agonisti del recettore GLP-1.
Il feedback della FDA ha confermato che:
- Gli studi farmacologici dimostrano l'attività di EL-22
- Gli studi non clinici supportano adeguatamente la sicurezza e l'efficacia nelle popolazioni sovrappeso/obese
- I dati dello studio di Fase 1 e gli studi non clinici sembrano sufficienti per avviare le sperimentazioni di Fase 2
EL-22 agisce sulla via della miostatina per favorire la salute muscolare durante i trattamenti per la perdita di peso. L'azienda prevede di presentare una domanda IND nel 2025 per iniziare le sperimentazioni cliniche di Fase 2. I precedenti studi di Fase 1 in Corea del Sud hanno mostrato che il trattamento è stato generalmente ben tollerato e sicuro in volontari sani.
Northstrive Biosciences, una subsidiaria de PMGC Holdings (NASDAQ: ELAB), recibió respuestas preliminares positivas de la FDA respecto a su reunión pre-IND para EL-22, un probiótico diseñado de forma innovadora para el tratamiento de la obesidad en combinación con agonistas del receptor GLP-1.
La retroalimentación de la FDA apoyó que:
- Los estudios farmacológicos demuestran la actividad de EL-22
- Los estudios no clínicos respaldan adecuadamente la seguridad y actividad en poblaciones con sobrepeso/obesidad
- Los datos del estudio de Fase 1 y los estudios no clínicos parecen suficientes para iniciar los ensayos de Fase 2
EL-22 actúa sobre la vía de la miostatina para apoyar la salud muscular durante los tratamientos para la pérdida de peso. La empresa planea presentar una solicitud IND en 2025 para comenzar los ensayos clínicos de Fase 2. Ensayos previos de Fase 1 en Corea del Sur mostraron que el tratamiento fue generalmente bien tolerado y seguro en voluntarios sanos.
Northstrive Biosciences는 PMGC Holdings(NASDAQ: ELAB)의 자회사로, 비만 치료를 위해 GLP-1 수용체 작용제와 병용하는 새로운 설계 프로바이오틱 EL-22에 대한 FDA 사전 IND 미팅에서 긍정적인 예비 반응을 받았습니다.
FDA의 피드백은 다음을 지지했습니다:
- 약리학 연구에서 EL-22의 활성이 입증됨
- 비임상 연구가 과체중/비만 인구에서 안전성과 활성을 충분히 뒷받침함
- 1상 연구 데이터와 비임상 연구가 2상 시험 개시에 충분한 것으로 보임
EL-22는 근육 건강을 지원하기 위해 마이오스타틴 경로를 표적으로 합니다. 회사는 2025년에 IND 신청을 제출하여 2상 임상시험을 시작할 계획입니다. 이전 한국에서의 1상 시험에서는 건강한 지원자에게서 치료가 일반적으로 잘 견디고 안전한 것으로 나타났습니다.
Northstrive Biosciences, une filiale de PMGC Holdings (NASDAQ : ELAB), a reçu des réponses préliminaires positives de la FDA concernant leur réunion pré-IND pour EL-22, un probiotique innovant conçu pour le traitement de l'obésité en association avec des agonistes du récepteur GLP-1.
Les retours de la FDA ont confirmé que :
- Les études pharmacologiques démontrent l’activité d’EL-22
- Les études non cliniques soutiennent adéquatement la sécurité et l’efficacité chez les populations en surpoids/obèses
- Les données de l’étude de phase 1 et les études non cliniques semblent suffisantes pour lancer les essais de phase 2
EL-22 cible la voie de la myostatine pour soutenir la santé musculaire durant les traitements de perte de poids. La société prévoit de déposer une demande IND en 2025 afin de démarrer les essais cliniques de phase 2. Les essais de phase 1 précédents en Corée du Sud ont montré que le traitement était généralement bien toléré et sûr chez des volontaires sains.
Northstrive Biosciences, eine Tochtergesellschaft von PMGC Holdings (NASDAQ: ELAB), erhielt positive vorläufige Rückmeldungen der FDA bezüglich ihres Pre-IND-Meetings für EL-22, ein neu entwickeltes probiotisches Mittel zur Behandlung von Fettleibigkeit in Kombination mit GLP-1-Rezeptoragonisten.
Das Feedback der FDA bestätigte, dass:
- Pharmakologische Studien die Aktivität von EL-22 nachweisen
- Nichtklinische Studien die Sicherheit und Wirksamkeit bei übergewichtigen/fettleibigen Populationen ausreichend unterstützen
- Daten aus der Phase-1-Studie und nichtklinische Studien ausreichend erscheinen, um Phase-2-Studien zu starten
EL-22 zielt auf den Myostatin-Weg ab, um die Muskelgesundheit während der Gewichtsabnahme zu fördern. Das Unternehmen plant, 2025 einen IND-Antrag einzureichen, um Phase-2-Studien zu beginnen. Frühere Phase-1-Studien in Südkorea zeigten, dass die Behandlung bei gesunden Probanden allgemein gut verträglich und sicher war.
- FDA supports progression to Phase 2 clinical trials
- Successful completion of Phase 1 safety trials
- Positive preclinical data showing physiological improvements
- Novel approach addressing unmet need in obesity treatment
- Manufacturing partnerships still in discussion phase
- IND application and Phase 2 trials not starting until 2025
Insights
FDA's positive feedback on EL-22 enables Northstrive to advance to Phase 2 trials, reducing regulatory uncertainty for this obesity/muscle preservation therapy.
The FDA's preliminary responses to Northstrive regarding their obesity treatment candidate EL-22 represent a significant regulatory milestone. The agency has specifically agreed that Northstrive's pharmacology studies support EL-22's activity and that both the nonclinical package and Phase 1 data appear adequate to support the initiation of the proposed Phase 2 trial.
This regulatory feedback essentially removes a key development hurdle by supporting the company's planned IND submission for a Phase 2 trial combining EL-22 with GLP-1 receptor agonists. In biotech development, clarity from regulators substantially reduces program risk and provides a defined pathway forward.
Northstrive has indicated they will forego the pre-IND meeting, suggesting the written feedback was sufficiently comprehensive and positive to proceed directly to IND filing. The company aims to submit this application in 2025, which keeps this program on a standard development timeline for an early-stage asset.
While this news confirms regulatory pathway clarity, investors should recognize that substantial clinical development work remains. The Phase 2 trial will be the first to test the combination approach with GLP-1 receptor agonists and will need to demonstrate the product's ability to preserve muscle mass during weight loss therapy - an important unmet need that could differentiate this approach in the rapidly expanding obesity treatment market.
Northstrive's myostatin-targeting probiotic could address critical muscle loss in GLP-1 weight loss therapies, with promising regulatory progress.
EL-22 represents an innovative approach to one of the most pressing challenges in modern obesity management. While GLP-1 receptor agonists have revolutionized weight loss treatment, they cause loss of both fat and muscle mass - a significant clinical concern that can affect metabolic health and physical function.
The scientific approach behind EL-22 is particularly intriguing. By engineering a probiotic to express myostatin on its surface, Northstrive is targeting a well-validated biological pathway for muscle regulation. Myostatin naturally inhibits muscle growth, and interventions targeting this pathway have shown promise for muscle preservation in multiple preclinical models.
The completed Phase 1 trial in South Korea demonstrating general tolerability provides initial safety reassurance, but the planned Phase 2 study will be crucial to determine whether this approach delivers meaningful preservation of muscle mass when combined with GLP-1 therapies in actual patients with obesity.
The FDA's agreement that Northstrive's pharmacology studies support EL-22's activity and that previous data is adequate to support a Phase 2 trial suggests the scientific rationale is sound. If successful in clinical development, this adjunctive therapy could address a significant limitation of current obesity treatments - particularly important as GLP-1 therapies become more widely used and muscle preservation becomes a greater priority in clinical practice.
- Northstrive Biosciences received preliminary meeting responses from the FDA regarding Northstrive’s nonclinical studies and clinical development plans for EL-22, administered in combination with GLP-1 receptor agonists.
- Northstrive believes the FDA responses encourage a path forward for filing an IND application to conduct a Phase 2 clinical trial in overweight or obese patients.
- EL-22 is leveraging a myostatin-engineered probiotic approach to address obesity’s pressing issue of preserving muscle while on weight loss treatments, including GLP-1 receptor agonists.
NEWPORT BEACH, Calif., April 24, 2025 (GLOBE NEWSWIRE) -- Northstrive Biosciences Inc. (“Northstrive”), a subsidiary of PMGC Holdings Inc. (NASDAQ: ELAB) (the “Company,” “PMGC,” “we,” or “our”), announced that it has received preliminary responses and commentary from the U.S. Food and Drug Administration (“FDA”) regarding its scheduled Type B pre-Investigational New Drug (“pre-IND”) meeting. Northstrive initially requested this meeting with the FDA to discuss nonclinical studies and Northstrive Biosciences’ clinical development plans for EL-22 administered in combination with GLP-1 receptor agonists. Northstrive believes the FDA’s responses support an IND submission for the initiation of a proposed Phase 2 clinical study.
The FDA’s responses indicated, amongst other things, that it agreed that (i) Northstrive’s pharmacology studies support EL-22 activity; (ii) Northstrive’s nonclinical studies appear adequate to support the safety and activity of EL-22 in overweight and obese human populations, and (iii) data from Northstrive’s Phase 1 study and completed nonclinical studies appear adequate to allow the initiation of the proposed Phase 2 clinical trial. Northstrive believes the FDA’s preliminary responses regarding the pre-IND meeting were sufficient and will forego the pre-IND meeting. Northstrive aims to file the Investigational New Drug application in 2025 and thereafter initiate a Phase 2 clinical trial to evaluate the combination of EL-22 with GLP-1 receptor agonists for obesity treatment. Northstrive is in ongoing discussions with Current Good Manufacturing Practices (cGMP) manufacturing partners to prepare the production of EL-22.
EL-22 is a novel, patent-pending engineered probiotic designed to express myostatin on its surface, targeting the validated myostatin pathway to support muscle health. Preclinical studies, including a 2022 publication in mdx mice (a model of Duchenne muscular dystrophy), demonstrated significant physiological and functional improvements.1 EL-22 has also completed a Phase 1 clinical trial in South Korea, where it was shown to be generally well-tolerated and safe in healthy volunteers.
“The nonclinical data package of EL-22, as well as the Phase 1 study conducted in South Korea, appear adequate to support the safety and activity in an obese patient population,” stated Deniel Mero, Co-founder of Northstrive Biosciences. “This positive reinforcement from the FDA is a critical milestone in the development of EL-22 to address one of obesity’s biggest unmet needs; the preservation of muscle for patients on GLP-1 therapies.”
About Northstrive Biosciences Inc.
Northstrive Biosciences Inc., a PMGC Holdings Inc. company, is a biopharmaceutical company focusing on the development and acquisition of cutting-edge aesthetic medicines. Northstrive’s lead asset, EL-22, leverages an engineered probiotic approach to address obesity’s pressing issue of preserving muscle while on weight loss treatments, including GLP-1 receptor agonists. For more information, please visit www.northstrivebio.com.
About PMGC Holdings Inc.
PMGC Holdings Inc. is a diversified holding company that manages and grows its portfolio through strategic acquisitions, investments, and development across various industries. Currently, our portfolio consists of three wholly owned subsidiaries: Northstrive Biosciences Inc., PMGC Research Inc., and PMGC Capital LLC. We are committed to exploring opportunities in multiple sectors to maximize growth and value. For more information, please visit https://www.pmgcholdings.com.
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as “believes,” “expects,” “plans,” “potential,” “would” and “future” or similar expressions such as “look forward” are intended to identify forward-looking statements. Forward-looking statements are made as of the date of this press release and are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy, activities of regulators and future regulations and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Although the Company believes that the expectations expressed in these forward-looking statements are reasonable, it cannot assure you that such expectations will turn out to be correct, and the Company cautions investors that actual results may differ materially from the anticipated results. Therefore, you should not rely on any of these forward-looking statements. These and other risks are described more fully in PMGC’s filings with the United States Securities and Exchange Commission (“SEC”), including the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 28, 2025, and its other documents subsequently filed with or furnished to the SEC. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at www.sec.gov. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, the Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
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1 Reference: Sung DK, Kim H, Park SE, Lee J, Kim JA, Park YC, Jeon HB, Chang JW, Lee J. A New Method of Myostatin Inhibition in Mice via Oral Administration of Lactobacillus casei Expressing Modified Myostatin Protein, BLS-M22, Int. J. Mol. Sci. 2022, 23, 9059. https://doi.org/10.3390/ijms23169059.
FAQ
What is the significance of FDA's response to ELAB's EL-22 obesity treatment?
When will ELAB begin Phase 2 clinical trials for EL-22?
What makes EL-22 different from other obesity treatments?
What were the results of EL-22's Phase 1 clinical trials?
How does ELAB's EL-22 work in combination with GLP-1 agonists?
