Adipositas-Therapie; Neue Wege
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| Neuester Beitrag: | 03.01.24 09:59 | von: Balu4u | Leser gesamt: | 20.814 |
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The phase 2b, randomised, double-blind, placebo-controlled trial will enrol 150 patients with BMI between 30 and 60 kg/m2, and T2DM.
The trial will be conducted at 15 sites in Australia only and investigate 1.2 mg and 1.8 mg doses of beloranib twice weekly.
Primary endpoint is change in body weight after 12 months; secondary endpoints include change in glycaemic control.
Comment:
Zafgen is pursuing a dual route to market for beloranib:
The primary focus is niche indications Prader-Willi Syndrome, where phase 3 recently begun, and obesity related to hypothalamic injury, currently in phase 2.
The secondary focus is on general obesity where the company now may target obese T2DM patients with the current phase 2b trial in Australia.
In a previous phase 2 in trial general obesity, 1.2 mg and 2.4 mg doses of beloranib produced 6.7% and 10.6% weight loss, respectively, after 12 weeks.
However, the 2.4 mg dose conferred tolerability issues and high withdrawal rates.
Whereas 2.4 mg is also tested in the ongoing phase 3 trial for PWS, it appears the company does not consider it suitable for general obesity in T2DM patients.
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Sicherheitsbedenken
the results from the non-human primate studies for the CTI-1601 program implied some safety concerns
The company has reported mortality in a 90-day non-human primate study which is believed to be due to bacterial meningitis infection and had no connection with the drug
https://www.benzinga.com/general/biotech/21/05/...itive-cti-1601-data
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https://investors.larimartx.com/news-releases/...ines-agency-priority
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FDA verhängt einen klinischen Stop für CTI-1601
Im Posting #37 hatte sich schon angdeutet, dass es zu Problemen kommen könnte.
"However, due to the additional regulatory requirements that come with responding to a formal clinical hold, we believe there is a possibility that the initiation of these trials may be delayed into 2022. Regarding the termination of the previously announced private placement financing, as of March 31, 2021, we have $81.4 million in cash and investments, which provides cash runway through the first half of 2022.”
https://investors.larimartx.com/news-releases/...al-hold-cti-1601-and
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95 Mio. $ Privatplatzierung geplatzt
https://endpts.com/...ug-and-a-95m-cash-infusion-goes-out-the-window/
Zahlen für Q1/21
- keine Umsätze
- Verlust 12 Mio. $
- Cash 81 Mio. $
- MK 132 Mio. $
https://investors.larimartx.com/news-releases/...r-2021-operating-and
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Wertpapier: Larimar Therapeutics Lt |
FDA hält klinischen Stop für CTI-1601 aufrecht
"FDA stated it is maintaining its clinical hold at this time and that additional data is needed to resolve the clinical hold. Larimar is further analyzing previously completed studies, and is evaluating if additional studies are warranted. The Company also intends to engage FDA to determine how best to provide these data."
https://investors.larimartx.com/news-releases/...r-2021-operating-and
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Ob Larimar mit einer niedrigeren Dosierung die FDA dazu bewegen kann, den klinischen Stop für CTI-1601 aufzuheben bleibt erstmal abzuwarten.
Zahlen für Q2/22
- keine Umsätze
- Verlust 8,7 Mio. $
- Cash 55 Mio. $
- MK 44 Mio. $
- projected cash runway through the third quarter of 2023
https://investors.larimartx.com/news-releases/...601-clinical-program
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über 160% Kursanstieg in den letzten 6 Monaten! Wer war mit dabei? Seit August 2022 hat sich einiges getan:
- im September hat die FDA den klinischen Stop aufgehoben
- zudem hatte der 10% Eigentümer Deerfield Private Design Fund IV, L.P im größeren Umfang Aktien erworben (zu durchschnittlich 3,15$)
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