Northstrive Biosciences Co-Founder Featured on Bear Bull Traders Following Announcement of Positive FDA Response Supporting Submission of IND for EL-22 Phase 2 Clinical Trial
Northstrive Biosciences, a subsidiary of PMGC Holdings (NASDAQ: ELAB), announced that Co-Founder Deniel Mero was featured in a Bear Bull Traders interview discussing recent FDA preliminary meeting responses. The responses support their plans for EL-22, a myostatin-engineered probiotic treatment designed to preserve muscle during weight loss with GLP-1 receptor agonists.
The FDA's feedback supports moving forward with an Investigational New Drug (IND) application for a Phase 2 clinical trial targeting overweight or obese patients. Bear Bull Traders, founded by Andrew Aziz, reaches 595,000 YouTube subscribers and maintains a network of over 7,000 active members and 100,000 newsletter subscribers globally.
Northstrive Biosciences, una controllata di PMGC Holdings (NASDAQ: ELAB), ha annunciato che il co-fondatore Deniel Mero è stato ospite in un'intervista di Bear Bull Traders per discutere le recenti risposte preliminari della FDA. Le risposte supportano i loro piani per EL-22, un trattamento probiotico ingegnerizzato con miostatina, progettato per preservare la massa muscolare durante la perdita di peso con agonisti del recettore GLP-1.
I feedback della FDA supportano l'avanzamento con una domanda di Nuovo Farmaco Sperimentale (IND) per una sperimentazione clinica di Fase 2 rivolta a pazienti sovrappeso o obesi. Bear Bull Traders, fondato da Andrew Aziz, conta 595.000 iscritti su YouTube e gestisce una rete di oltre 7.000 membri attivi e 100.000 iscritti alla newsletter a livello globale.
Northstrive Biosciences, una filial de PMGC Holdings (NASDAQ: ELAB), anunció que el cofundador Deniel Mero fue entrevistado en Bear Bull Traders para hablar sobre las recientes respuestas preliminares de la FDA. Las respuestas respaldan sus planes para EL-22, un tratamiento probiótico diseñado con ingeniería de miostatina para preservar el músculo durante la pérdida de peso con agonistas del receptor GLP-1.
La retroalimentación de la FDA apoya avanzar con una solicitud de Nuevo Fármaco en Investigación (IND) para un ensayo clínico de Fase 2 dirigido a pacientes con sobrepeso u obesidad. Bear Bull Traders, fundado por Andrew Aziz, cuenta con 595,000 suscriptores en YouTube y mantiene una red de más de 7,000 miembros activos y 100,000 suscriptores al boletín a nivel mundial.
Northstrive Biosciences는 PMGC Holdings(NASDAQ: ELAB)의 자회사로, 공동 창립자 데니엘 메로가 Bear Bull Traders 인터뷰에 출연하여 최근 FDA 예비 회의 응답에 대해 논의했다고 발표했습니다. 이 응답들은 GLP-1 수용체 작용제와 함께 체중 감량 중 근육을 보존하도록 설계된 근육억제단백질 조작 프로바이오틱 치료제 EL-22에 대한 계획을 뒷받침합니다.
FDA의 피드백은 과체중 또는 비만 환자를 대상으로 한 2상 임상시험을 위한 임상시험용 신약(IND) 신청 진행을 지지합니다. Andrew Aziz가 설립한 Bear Bull Traders는 유튜브 구독자 595,000명을 보유하고 있으며, 전 세계적으로 7,000명 이상의 활동 회원과 100,000명의 뉴스레터 구독자를 유지하고 있습니다.
Northstrive Biosciences, une filiale de PMGC Holdings (NASDAQ : ELAB), a annoncé que le cofondateur Deniel Mero a été interviewé par Bear Bull Traders pour discuter des récentes réponses préliminaires de la FDA. Ces réponses soutiennent leurs projets concernant EL-22, un traitement probiotique modifié par ingénierie de la myostatine, conçu pour préserver la masse musculaire lors de la perte de poids avec des agonistes du récepteur GLP-1.
Les retours de la FDA appuient la soumission d'une demande d'Investigational New Drug (IND) pour un essai clinique de phase 2 ciblant des patients en surpoids ou obèses. Bear Bull Traders, fondé par Andrew Aziz, compte 595 000 abonnés sur YouTube et gère un réseau de plus de 7 000 membres actifs ainsi que 100 000 abonnés à sa newsletter à l'échelle mondiale.
Northstrive Biosciences, eine Tochtergesellschaft von PMGC Holdings (NASDAQ: ELAB), gab bekannt, dass Mitbegründer Deniel Mero in einem Bear Bull Traders-Interview über die jüngsten vorläufigen Rückmeldungen der FDA sprach. Die Antworten unterstützen ihre Pläne für EL-22, eine myostatin-engineerierte probiotische Behandlung, die darauf abzielt, Muskeln während des Gewichtsverlusts mit GLP-1-Rezeptoragonisten zu erhalten.
Das Feedback der FDA unterstützt die Einreichung eines Investigational New Drug (IND)-Antrags für eine Phase-2-Studie bei übergewichtigen oder adipösen Patienten. Bear Bull Traders, gegründet von Andrew Aziz, erreicht 595.000 YouTube-Abonnenten und unterhält ein Netzwerk von über 7.000 aktiven Mitgliedern sowie 100.000 Newsletter-Abonnenten weltweit.
- FDA's preliminary response supports progression to Phase 2 clinical trials
- Addresses significant unmet need in obesity treatment market
- Potential synergy with popular GLP-1 receptor agonist medications
- Early stage of development - still requires IND approval
- No clinical efficacy data available yet
Insights
FDA's positive preliminary response enables Northstrive to advance toward IND submission for EL-22, addressing muscle loss in GLP-1 patients.
The FDA's preliminary meeting responses to Northstrive Biosciences regarding their nonclinical studies and clinical development plans for EL-22 represent a meaningful regulatory milestone. This feedback is specifically characterized as encouraging "a path forward for filing an IND application" for a Phase 2 clinical trial in overweight or obese patients.
The scientific approach behind EL-22 targets a significant unaddressed concern in current obesity treatment. Northstrive is developing a myostatin-engineered probiotic designed to preserve muscle mass when administered alongside GLP-1 receptor agonists. This addresses a recognized limitation of current GLP-1 therapies, which can cause loss of both fat and muscle tissue during weight reduction.
From a regulatory perspective, receiving constructive pre-IND feedback from the FDA is an important de-risking event, though multiple steps remain before clinical trials can commence. The company must still formally submit their IND application, which the FDA will then review to determine if the proposed Phase 2 clinical study can proceed safely.
The specific indication targeting muscle preservation as a companion therapy to GLP-1 receptor agonists represents a strategic focus on a well-defined clinical need. If successful in development, this approach could potentially complement rather than compete with established obesity treatments, addressing a recognized side effect that limits their clinical utility.
Northstrive's positive FDA feedback supports advancing EL-22 to Phase 2 trials, targeting a growing unmet need in obesity treatment market.
This regulatory progress for Northstrive Biosciences represents a strategic positioning in the rapidly evolving weight management therapeutic landscape. The preliminary FDA responses support their development path for EL-22, which addresses the critical issue of muscle preservation during GLP-1-mediated weight loss therapy.
From a market opportunity perspective, Northstrive is targeting a clearly defined and growing problem. As GLP-1 receptor agonist use expands for obesity treatment, the issue of muscle mass preservation becomes increasingly important for long-term patient outcomes. By developing a companion therapy rather than a competing primary treatment, Northstrive has selected a development path that could see fewer competitive barriers.
The company's myostatin-engineered probiotic approach represents an innovative biological mechanism for addressing this side effect. While the article doesn't detail the preclinical evidence, the FDA's supportive response suggests the scientific approach has demonstrated sufficient promise to advance toward human studies.
For PMGC Holdings, this subsidiary's progress indicates advancement of a differentiated asset within their portfolio. The development of EL-22 as a muscle-preserving adjunctive therapy represents a focused approach to a specific metabolic challenge, rather than attempting to compete directly in the crowded primary obesity treatment space.
NEWPORT BEACH, Calif., April 28, 2025 (GLOBE NEWSWIRE) -- Northstrive Biosciences Inc. (“Northstrive”), a subsidiary of PMGC Holdings Inc. (NASDAQ: ELAB) (the “Company,” “PMGC,” “we,” or “our”), is proud to announce that Co-Founder Deniel Mero was recently featured in an exclusive interview hosted by Bear Bull Traders, a leading global online stock trading community for professional and aspiring traders.
During the interview, Mr. Mero discussed Northstrive’s recent milestone: receiving 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. 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.
Bear Bull Traders is a respected trading education platform founded by bestselling author Andrew Aziz. Along with its 595,000 YouTube subscribers, Bear Bull Traders has an extensive network of over 7,000 active members and 100,000 newsletter subscribers worldwide, Bear Bull Traders offers a dynamic environment for traders through expert mentorship, live trading rooms, educational courses, and a vibrant, supportive community.
“We are honored to share our story with the Bear Bull Traders community, that, like Northstrive, is committed to leveraging innovation,” said Deniel Mero, Co-founder of Northstrive Biosciences. “We believe the FDA responses encourage a path forward for filing an IND application to conduct a Phase 2 clinical trial in overweight or obese patients; addressing one of obesity’s biggest unmet needs.”
The full interview featuring Deniel Mero can be viewed here.
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.
About Bear Bull Traders
Bear Bull Traders is an international trading education community founded in 2015 by Andrew Aziz. With over 100,000 members globally, Bear Bull Traders offers comprehensive education, expert mentorship, and community support to empower traders toward success in financial markets.
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FAQ
What is the significance of FDA's response to ELAB's EL-22 drug development?
How does ELAB's EL-22 work with GLP-1 receptor agonists?
What is the next development phase for ELAB's EL-22 treatment?
What unmet need does ELAB's EL-22 address in obesity treatment?
