Clinical Catch-Up: Adocia, Allecra Therapeutics & Aldeyra Therapeutics
06 Oct 2022
Orphan Drug
Adocia, Allecra Therapeutics and Aldeyra Therapeutics are ending the week with promising results from their respective clinical trials on hard-to-treat diseases.
Continue reading below.
Adocia Anti-Obesity Candidate Fares Well vs Humalog In Phase II Study
New data released Thursday from Adocia's Phase II trial of M1Pram in obese people with Type I Diabetes demonstrated the drug's ability to deliver significant weight loss results versus Humalog.
M1Pram, a combination of M1 insulin and pramlintide, is in a regular insulin pen form, and Adocia has a patent for coformulation up to 2038. Pramlintide is an FDA-approved amylin analog used as an insulin adjunct in people with type I and type II diabetes and can improve glycemic control, weight loss and general well-being.
Post-hoc analyses of the M1Pram study showed that those who used the combination saw a reduction in body mass index by 5.56 kg at week 16 compared to a decrease of only 0.57 kg in those who took Humalog. Weight loss also did not plateau by the end of the study period.
In terms of glycemic control, M1Pram offered results "as good as gold standard mealtime insulin," the report stated. The drug also reduced the participants' daily dose of prandial insulin by 21%.
Adocia is reportedly seeking partnership opportunities to further develop M1Pram's potential.
Allecra's Proposed cUTI Drug Combo Meets Superiority Endpoint In Phase III
Allecra Therapeutics' first full analysis of the completed Phase III ALLIUM trial of cefepime/enmetazobactam released Wednesday demonstrated the combination drug candidate's effectiveness in treating people with complicated urinary tract infections (cUTIs).
Results published in the Journal of the American Medical Association (JAMA) showed that cefepime/enmetazobactam met non-inferiority and superiority criteria when it was compared to piperacillin/tazobactam in the primary outcome of microbiological eradication and clinical cure.
The primary outcome was achieved in 79.1% of the cefepime/enmetazobactam group versus 58.9% in the piperacillin/tazobactam group. Treatment-emergent adverse events cropped up, but most were mild to moderate.
Allecra is currently working with ADVANZ PHARMA to commercialize cefepime/enmetazobactam in the U.K., Switzerland, Norway and the European Union and will complete submission for marketing authorization by the end of the year. Allecra is seeking commercialization partners in the U.S. and working on regulatory submissions.
Aldeyra Retinal Disease Drug Achieves Primary Endpoint, No Safety Concerns
Aldeyra Therapeutics announced Thursday that its proposed treatment for proliferative vitreoretinopathy (PVR) achieved the primary endpoint of numerical superiority versus routine surgical care in preventing retinal detachment.
ADX-2191 (methotrexate injection, USP) is a sterile, non-compounded intravitreal formulation designed to prevent or treat retinal diseases. The FDA gave ADX-2191 an orphan drug designation for the prevention of proliferative vitreoretinopathy, and the treatment of primary vitreoretinal lymphoma and retinitis pigmentosa.
Part I of Aldeyra's Phase III GUARD trial was conducted over six months, with 68 patients receiving ADX-2191 and 38 receiving a routine surgical intervention. Although secondary or exploratory endpoints were not met, the drug exhibited superiority in reducing the retinal detachment rate, hypotony, complete retinal detachment by six months, epiretinal membrane formation and macular attachment.
Given these results, Aldeyra plans to hold a Type C meeting with the U.S. FDA by the first half of 2023 to discuss completing clinical development activities for the drug.
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