Gaining Momentum, Biodexa is Advancing Two Recent Acquisitions Through the Clinic
Biodexa Pharmaceuticals (NASDAQ:BDRX) is advancing its transformation from a drug delivery innovator to a therapeutics company, focusing on diabetes and cancer treatments. The company's strategy involves repurposing proven molecules for new indications. Their key product eRapa for familial adenomatous polyposis (FAP) showed promising Phase 2 results with a 29% median decrease in polyp burden and 89% non-progression rate. The Phase 3 study is largely funded through a $25.5 million grant and matching funds. Additionally, Biodexa is developing MTX110 for glioblastoma and tolimidone for Type 1 diabetes, with several clinical milestones expected in the coming months.
Biodexa Pharmaceuticals (NASDAQ:BDRX) sta avanzando nella sua trasformazione da innovatore nel delivery di farmaci a azienda terapeutica, concentrandosi su trattamenti per il diabete e il cancro. La strategia dell'azienda prevede il riutilizzo di molecole comprovate per nuove indicazioni. Il loro prodotto chiave, eRapa, per la poliomatosi adenomatosa familiare (FAP), ha mostrato risultati promettenti nella Fase 2, con una diminuzione mediana del 29% nel carico di polipi e un tasso di non progressione dell'89%. Lo studio di Fase 3 è finanziato principalmente attraverso una sovvenzione di 25,5 milioni di dollari e fondi corrispondenti. Inoltre, Biodexa sta sviluppando MTX110 per il glioblastoma e tolimidone per il diabete di tipo 1, con diversi traguardi clinici attesi nei prossimi mesi.
Biodexa Pharmaceuticals (NASDAQ:BDRX) está avanzando en su transformación de innovador en la entrega de medicamentos a empresa terapéutica, enfocándose en tratamientos para la diabetes y el cáncer. La estrategia de la compañía implica la reutilización de moléculas probadas para nuevas indicaciones. Su producto clave, eRapa, para la poliposis adenomatosa familiar (FAP), mostró resultados prometedores en la Fase 2 con una disminución mediana del 29% en la carga de pólipos y una tasa de no progresión del 89%. El estudio de Fase 3 está financiado en gran medida a través de una subvención de 25,5 millones de dólares y fondos complementarios. Además, Biodexa está desarrollando MTX110 para glioblastoma y tolimidona para la diabetes tipo 1, con varios hitos clínicos esperados en los próximos meses.
바이오덱사 제약(Biodexa Pharmaceuticals) (NASDAQ:BDRX)는 약물 전달 혁신가에서 치료 회사로의 전환을 진행하고 있으며, 당뇨병 및 암 치료에 집중하고 있습니다. 회사의 전략은 검증된 분자를 새로운 적응증에 재사용하는 것을 포함합니다. 그들의 주요 제품 eRapa는 가족성 선종폴립증(FAP)에 대해 2상에서 유망한 결과를 보여주었으며, 폴립 부담이 29% 평균 감소하고 비진행률이 89%에 달했습니다. 3상 연구는 2,550만 달러의 보조금과 일치하는 자금으로 대규모로 자금 지원됩니다. 또한, 바이오덱사는 MTX110을 교모세포종을 위해, 톨리미돈을 1형 당뇨병을 위해 개발 중이며, 향후 몇 개 월 내에 여러 임상 이정표가 기대되고 있습니다.
Biodexa Pharmaceuticals (NASDAQ:BDRX) avance dans sa transformation d'innovateur en délivrance de médicaments à entreprise thérapeutique, se concentrant sur les traitements pour le diabète et le cancer. La stratégie de l'entreprise consiste à réutiliser des molécules éprouvées pour de nouvelles indications. Leur produit phare, eRapa, pour la polypose adénomateuse familiale (FAP), a montré des résultats prometteurs lors de la phase 2, avec une diminution médiane de 29 % de la charge polyposa et un taux de non-progression de 89 %. L'étude de phase 3 est en grande partie financée par une subvention de 25,5 millions de dollars et des fonds correspondants. De plus, Biodexa développe MTX110 pour le glioblastome et tolimidone pour le diabète de type 1, avec plusieurs jalons cliniques attendus dans les mois à venir.
Biodexa Pharmaceuticals (NASDAQ:BDRX) wandelt sich von einem Innovator in der Medikamentenabgabe zu einem therapeutischen Unternehmen, das sich auf Behandlungen für Diabetes und Krebs konzentriert. Die Strategie des Unternehmens umfasst die Umnutzung bewährter Moleküle für neue Indikationen. Ihr Schlüsselprodukt eRapa für familiäre adenomatöse Polypose (FAP) zeigte vielversprechende Ergebnisse in der Phase 2, mit einer medianen Verringerung der Polypenlast um 29% und einer Nicht-Progressionsrate von 89%. Die Phase-3-Studie wird größtenteils durch einen Zuschuss in Höhe von 25,5 Millionen USD und entsprechende Mittel finanziert. Darüber hinaus entwickelt Biodexa MTX110 für Glioblastome und tolimidone für Typ-1-Diabetes, wobei in den kommenden Monaten mehrere klinische Meilensteine erwartet werden.
- Phase 2 eRapa trial showed strong results with 29% polyp reduction and 89% non-progression rate
- Secured $25.5 million in funding for eRapa Phase 3 trial through FDA submission
- eRapa market potential estimated at $500M-$1B peak annual sales
- MTX110 showed significant survival improvement in glioblastoma patients (12-13 months vs. 2-9 months)
- Strategic acquisitions completed with minimal upfront costs (5% and 9.9% stock payments)
- Company bearing all development costs for licensed products
- Revenue sharing agreements with licensors will impact future profits
- Multiple clinical trials requiring significant ongoing investment
Insights
The clinical progress of Biodexa's pipeline shows significant potential, particularly with eRapa for FAP treatment. The
The MTX110 data for glioblastoma showing 12-13 months survival versus 2-9 months historical data is clinically meaningful. The tolimidone program for Type 1 diabetes, while earlier stage, targets a significant unmet need in beta cell preservation. Multiple near-term catalysts including the FDA Type C meeting, Phase 3 initiation and interim NMIBC data provide clear value inflection points.
Biodexa's business model of in-licensing clinical-stage assets with proven safety profiles represents an intelligent risk-mitigation strategy. The deal structures are particularly favorable - eRapa required only
The company's focus on orphan indications provides strong market protection through exclusivity periods. With multiple shots on goal across oncology and diabetes, plus near-term catalysts, the risk-reward profile appears attractive given the current
CARDIFF, UK / ACCESSWIRE / November 21, 2024 / Biodexa Pharmaceuticals PLC (NASDAQ:BDRX), an acquisition-focused clinical-stage biopharmaceutical company focused on developing treatments for unmet medical needs, has made significant progress in transforming itself from a drug delivery innovator to a therapeutics company with a focus on drugs to fight diabetes and cancer.
Biodexa's strategy is not based on discovering new medicines; rather it looks to reduce the risk of failure in the clinic by re-purposing molecules with proven safety records for new indications. When Biodexa sees potential, it acquires these products from third parties under licensing agreements which generally call for the company to bear the costs of development and share the rewards of commercialization with the licensor.
eRapa soon to enter Phase 3
The shift to a therapeutics company is paying off for Biodexa as illustrated by its recent acquisition of eRapa for familial adenomatous polyposis, or FAP. FAP is an inherited condition that puts people at a much greater risk of developing colon cancer. With FAP, hundreds or thousands of precancerous polyps grow throughout the gastrointestinal tract. There is no approved therapeutic option for treating FAP patients, for whom active surveillance and surgical resection of the colon and/or rectum remain the standard of care. People with FAP - which usually appears in adolescence - end up eventually having their entire colon removed and using a colostomy bag. If left untreated, there is a
"eRapa could be a transformational deal for Biodexa," says Biodexa CEO Stephen Stamp. "The deal included an upfront payment of only
As covered by Benzinga earlier this year, Biodexa published six-month phase 2 data, as well as 12-month data for eRapa that showed a median decrease in polyp burden of
Phase 3 Through To NDA Largely Funded
The FAP program was awarded a
"There are approximately 40,000 and 60,000 patients with FAP in the US and Europe respectively. As an orphan drug, eRapa will benefit from seven and 10 year exclusivity in the US and Europe, respectively, and based on the pricing of other orphan drugs, could achieve peak annual sales of
It doesn't end there. Biodexa said there is currently an ongoing placebo-controlled phase 2 study of eRapa for non-muscle invasive bladder cancer (NMIBC), an early-stage bladder cancer. Biodexa said about 130 of 168 patients have been recruited so far, and it is evaluating the possibility of an interim analysis around the end of the year.
Furthermore, in October, the company announced the status of patients in Cohort A of the phase 1 study of its drug MTX110 - a solubilized formulation of the cancer drug panobinostat which is marketed as Farydak® - for recurrent glioblastoma, the most common and aggressive malignant primary brain cancer: all patients at that point had overall survival of between 12 and 13 months since starting treatment with MTX110, a significant improvement on overall survival of 2 to 9 months in the background population.
Tolimidone, a Phase 2-Ready Asset For Type 1 Diabetes
The company is currently working with the University of Alberta to initiate a Phase 2a dose confirmation study of tolimidone for the treatment of Type 1 diabetes. The study is designed to build on the preclinical data, which Biodexa said suggested tolimidone could have a proliferative impact on pancreatic beta cells, the cells responsible for insulin production.
Biodexa in-licensed tolimidone from Melior Discovery in December 2023 in return for
"Over the next few months, we can expect the outcome of the Type C meeting with FDA on eRapa phase 3 program, the start of recruitment of the registrational Phase 3 study of eRapa in FAP, the start of recruitment of a Phase 2a study of tolimidone in Type 1 diabetes and interim analysis of eRapa phase 2 study in NMIBC," said Stamp. "Another busy and productive period for our team here at Biodexa."
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