Ascendis Pharma A/s · NASDAQ:ASND
Ascendis Pharma A/s — Technical Presentation (May 2021)
11 slides from Ascendis Pharma A/s's technical presentation, May 11, 2021
Slide 1: TransCon PTH – 58-Week Open-Label Extension (OLE) Update
Ascendis Pharma A/S TransConTM PTH – 58-Week Open-Label Extension (OLE) Update May 10, 2021 All product candidates are investigational. For investor communication only. Not for use in promotion or product commercialisation. Exhibit 99.1
Slide 2: Cautionary Note On Forward-Looking Statements
Cautionary Note On Forward-Looking Statements This presentation contains forward-looking statements. All statements other than statements of historical facts contained in this presentation, such as statements regarding our business strategy, prospective products, clinical trial results, product appr
Slide 3: Preliminary PaTH Forward Open-Label Extension (OLE) Data at 58 Weeks
Preliminary PaTH Forward Open-Label Extension (OLE) Data at 58 Weeks 58 subjects continue in the open-label extension beyond 58 weeks* Continued treatment with TransCon PTH demonstrated that: 91% of subjects were off standard of care therapy** Urinary calcium maintained in the normal range Bone mark
Slide 4: PaTH Forward OLE Mean Active Vitamin D Dose
OLE starts PaTH Forward OLE Mean Active Vitamin D Dose TransCon PTH enabled discontinuation of active vitamin D within two weeks of treatment initiation Preliminary PaTH Forward OLE week 58 data from live database snapshot. Data on file. Mean Active Vitamin D Dose µg/day (± SE) Weeks
Slide 5: PaTH Forward OLE Mean Calcium Supplement Dose
OLE starts PaTH Forward OLE Mean Calcium Supplement Dose TransCon PTH enabled rapid and continuous calcium supplement reduction; 40 of 58 subjects were taking 0 mg, and 53 of 58 subjects were taking 0 to 600 mg at week 58 Preliminary PaTH Forward OLE week 58 data from live database snapshot. Data on
Slide 6: PaTH Forward OLE Mean Serum Calcium and Mean 24-Hour Urine Calcium
Mean Calcium Corrected for Albumin mg/dL (± SE) PaTH Forward OLE Mean Serum Calcium and Mean 24-Hour Urine Calcium Preliminary PaTH Forward OLE week 58 data from live database snapshot. Data on file. ULN = Upper limit of normal. Mean 24-hour Urine Calcium mg/24hr (± SE) Mean 24-hour urine calcium no
Slide 7: PaTH Forward OLE SF-36 Health Survey Domain Mean Scores
PaTH Forward OLE SF-36® Health Survey Domain Mean Scores (SD) - Continued Normalization of Quality of Life Preliminary PaTH Forward OLE week 58 data from live database snapshot. Data on file. Green: Means above lower limit of population norm (47) All TransCon PTH (N = 59) SF-36 Domain Baseline Week
Slide 8: PaTH Forward OLE - P1NP and CTx Bone Markers
OLE starts OLE starts PaTH Forward OLE - P1NP and CTx Bone Markers Preliminary PaTH Forward OLE week 58 data from live database snapshot. Data on file. Procollagen 1N-Terminal Propeptide ng/mL (± SE) TransCon PTH treatment initially increased the levels of anabolic and catabolic bone markers which w
Slide 9: Preliminary PaTH Forward OLE Safety Summary
Preliminary PaTH Forward OLE Safety Summary at 58 Weeks TransCon PTH was well-tolerated at all doses administered 58 out of 59 randomized subjects currently receiving TransCon PTH in OLE* No drug-related serious TEAEs were reported No TEAEs leading to discontinuation of study drug TEAEs with TransCo
Slide 10: PaTH Forward OLE Overall TEAE Summary
PaTH Forward OLE Overall TEAE Summary Preliminary PaTH Forward OLE week 58 data from live database snapshot. Data on file. Percentages are calculated based on the number of subjects in the Safety Population. In the severity categories, subjects are displayed for the highest severity only. An AE is c
Slide 11: TransCon PTH: A Potential PTH Replacement Therapy
TransCon PTH: A Potential PTH Replacement Therapy Preliminary phase 2 PaTH Forward OLE results at 58 weeks demonstrated:* Durable benefits of TransCon PTH TransCon PTH was well-tolerated at all doses Subjects appeared to be establishing physiologic calcium metabolism* Bone markers continued to trend