Bioxytran Completes Randomized Clinical Trial For its Broad-Spectrum Antiviral Drug
Bioxytran (OTCQB: BIXT) announced on October 29, 2025 the completion of a randomized, double-blind, placebo-controlled dose-optimization trial for its oral broad-spectrum antiviral candidate ProLectin-M. The company says prior Phase 2 results showed treated participants reached undetectable PCR viral levels in less than one week. Data from the new trial will be used to inform a phase 3 trial design for CDSCO and will be submitted to the FDA at the agency's request. Bioxytran expects to compile detailed safety and efficacy endpoints for peer-reviewed publication and plans to submit full results in the coming weeks.
Bioxytran (OTCQB: BIXT) ha annunciato il 29 ottobre 2025 il completamento di uno studio randomizzato, in doppio cieco, controllato con placebo, di ottimizzazione della dose per il suo candidato antivirale a spettro largo orale ProLectin-M. L'azienda afferma che i risultati della fase 2 hanno mostrato che i partecipanti trattati hanno raggiunto livelli virali PCR non rilevabili in meno di una settimana. I dati del nuovo trial saranno utilizzati per informare la progettazione di uno studio di fase 3 per CDSCO e saranno presentati alla FDA su richiesta dell'agenzia. Bioxytran prevede di raccogliere endpoint dettagliati di sicurezza ed efficacia per una pubblicazione tra pari e intende presentare i risultati completi nelle prossime settimane.
Bioxytran (OTCQB: BIXT) anunció el 29 de octubre de 2025 la finalización de un ensayo aleatorizado, doble ciego, controlado con placebo, de optimización de dosis para su candidato antiviral de amplio espectro oral ProLectin-M. La empresa dice que los resultados de la Fase 2 mostraron que los participantes tratados alcanzaron niveles virales de PCR indetectables en menos de una semana. Los datos del nuevo ensayo se utilizarán para informar el diseño de un ensayo de Fase 3 para CDSCO y se presentarán a la FDA a petición de la agencia. Bioxytran espera compilar endpoints detallados de seguridad y eficacia para su publicación en revisión por pares y planea presentar los resultados completos en las próximas semanas.
Bioxytran(OTCQB: BIXT)가 2025년 10월 29일에 경구용 광범위 항바이러스 표적 후보물질 ProLectin-M의 용량 최적화 시험을 무작위화, 위약 대조, 이중 맹검으로 완료했다고 발표했습니다. 회사 측은 2상 결과에서 치료받은 참가자들이 일주일 이내에 PCR 바이러스 수치가 검출 불가 수준에 도달했다고 말합니다. 새로운 시험의 데이터는 CDSCO를 위한 3상 설계를 알리는 데 사용되며 기관의 요청에 따라 FDA에 제출될 예정입니다. Bioxytran는 동료 평가를 거친 출판을 위해 안전성 및 효과성의 자세한 엔드포인트를 수집할 것으로 기대하며, 향후 몇 주 내에 전체 결과를 제출할 계획입니다.
Bioxytran (OTCQB: BIXT) a annoncé le 29 octobre 2025 l'achèvement d'un essai randomisé, en double aveugle, contrôlé par placebo, d'optimisation de la dose pour son candidat antiviral à large spectre oraux ProLectin-M. La société indique que les résultats de la phase 2 ont montré que les participants traités ont atteint des Niveaux viraux PCR indétectables en moins d'une semaine. Les données du nouvel essai seront utilisées pour éclairer la conception d'un essai de phase 3 pour la CDSCO et seront soumises à la FDA à la demande de l'agence. Bioxytran prévoit de compiler des endpoints détaillés de sécurité et d'efficacité en vue d'une publication par les pairs et envisage de soumettre les résultats complets dans les prochaines semaines.
Bioxytran (OTCQB: BIXT) gab am 29. Oktober 2025 die Fertigstellung einer randomisierten, doppelblinden, placebokontrollierten Dosisoptimierungsstudie für seinen oralen Breitband-Antiviralenkandidaten ProLectin-M bekannt. Das Unternehmen teilt mit, dass frühere Phase-2-Ergebnisse gezeigt haben, dass behandelte Teilnehmer in weniger als einer Woche unnachweisliche PCR-Viruslevel erreichten. Die Daten der neuen Studie werden verwendet, um das Design einer Phase-3-Studie für CDSCO zu informieren, und werden auf Anfrage der Behörde dem FDA vorgelegt. Bioxytran erwartet, detaillierte Sicherheits- und Wirksamkeitsendpunkte für eine begutachtete Veröffentlichung zusammenzustellen und plant, die vollständigen Ergebnisse in den kommenden Wochen einzureichen.
Bioxytran (OTCQB: BIXT) أعلنت في 29 أكتوبر 2025 عن اكتمال تجربة عشوائية، مزدوجة التعمية، محكومة بالعلاج الوهمي لتحسين جرعة candidate مضاد الفيروسات واسع النطاق الفموي ProLectin-M. وتقول الشركة إن نتائج المرحلة 2 أظهرت أن المشاركين المعالجين وصلوا إلى مستويات فيروسية PCR غير قابلة للكشف في أقل من أسبوع. سيتم استخدام بيانات التجربة الجديدة لإبلاغ تصميم تجربة المرحلة 3 لــ CDSCO وسيتم تقديمها إلى FDA عند طلب الوكالة. وتتوقع Bioxytran تجميع نقاط نهاية السلامة والفعالية التفصيلية للنشر في مراجعة الأقران وتخطط لتقديم النتائج الكاملة في الأسابيع القادمة.
Bioxytran (OTCQB: BIXT) 于 2025年10月29日 宣布完成其口服广谱抗病毒候选药物 ProLectin-M 的随机、双盲、安慰剂对照剂量优化试验。公司表示，先前的二期结果显示，接受治疗的参与者在不到一周的时间内达到 PCR病毒水平不可检测。来自新试验的数据将用于为 CDSCO 的三期试验设计提供信息，并应机构的要求提交给 FDA。Bioxytran 预计编制详细的安全性和有效性终点，以便同行评审发表，并计划在未来几周内提交完整结果。
- Completed randomized double-blind, placebo-controlled trial on Oct 29, 2025
- Prior Phase 2: undetectable PCR in treated participants in <1 week
- Planned regulatory submissions to CDSCO and FDA
- Company expects peer-reviewed publication of full trial data in coming weeks
- Full efficacy and safety data not yet released or peer-reviewed
- No phase 3 approval or authorization yet; next steps depend on regulatory review
- Press release gives no quantitative safety endpoints or participant counts
- Data from the dose optimization trial expected soon
- ProLectin-M is positioned as the first oral antiviral sugar chemistry drug
BOSTON, MASSACHUSETTS, Oct. 29, 2025 (GLOBE NEWSWIRE) -- BIOXYTRAN, INC. (OTCQB: BIXT) (the “Company”), a clinical stage biotechnology company pioneering innovative therapies for viral diseases, is pleased to announce the successful completion of its second randomized double-blind, placebo-controlled clinical trial for its leading broad-spectrum antiviral drug candidate, ProLectin-M. Data from the trial is expected to inform both the CDSCO for a phase 3 trial design and will also be submitted to the FDA pursuant to their request.
This second randomized controlled trial was designed to confirm the groundbreaking results from the Company's earlier Phase 2 study, which demonstrated that ProLectin-M achieved undetectable levels of Polymerase Chain Reaction (PCR) and infection in less than one week in treated participants. The successful execution of this third independent trial significantly strengthens the robust evidence for ProLectin-M's potential as a rapid-acting oral therapeutic for a wide range of viral infections.
The comprehensive data from this third clinical trial, including detailed safety and efficacy endpoints, is expected to be compiled for publication in a peer-reviewed medical journal. The company anticipates that the full results will be submitted for publication in the coming weeks.
"The successful completion of our third trial is a significant achievement for Bioxytran and represents a potential paradigm shift in antiviral therapy," said Dr. David Platt, CEO of Bioxytran. "To have consistently targeted undetectable viral presence by Polymerase Chain Reaction (PCR) in such a short timeframe across multiple trials is a remarkable achievement. As the first oral antiviral based on the power of sugar chemistry, ProLectin-M is on track to deliver a therapeutic that could fundamentally change how the world manages viral outbreaks."
About Bioxytran, Inc.
Bioxytran, Inc. is at the forefront of developing linear complex carbohydrate-based therapeutics to address critical unmet medical needs in its antiviral platform technology.
For more information, visit www.bioxytraninc.com
Investor Relations
Michael Sheikh
509-991-0245
mike.sheikh@bioxytraninc.com
Forward-Looking Statements
This press release includes forward-looking statements as defined under federal law, including those related to the performance of technology described in this press release. These forward-looking statements are generally identified by the words “believe,” “expect,” “anticipate,” “estimate,” “intend,” “plan,” and similar expressions, although not all forward-looking statements contain these identifying words. Such statements are subject to significant risks, assumptions and uncertainties. Known material factors that could cause Bioxytran’s actual results to differ materially from the results contemplated by such forward-looking statements are described in the forward-looking statements and risk factors in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, and those risk factors set forth from time-to-time in other filings with the Securities and Exchange Commission. Bioxytran undertakes no obligation to correct or update any forward-looking statement, whether as a result of new information, future events, or otherwise, except to the extent required under federal securities laws.
FAQ
What did Bioxytran (BIXT) announce on October 29, 2025 about ProLectin-M?
Did ProLectin-M reach undetectable viral levels in trials and how quickly?
Will Bioxytran (BIXT) submit ProLectin-M data to regulators and which ones?
When will full ProLectin-M trial results be published for investors?
Does the October 29, 2025 announcement mean ProLectin-M is approved for use?
