A Phase 3, Multicenter, Single Arm, Open-Label Trial, Investigating the Safety, Tolerability and Efficacy of TransCon PTH Administered Subcutaneously Daily in Japanese Adult Subjects with Hypoparathyroidism - PaTHway Japan Trial

Start Date02 Nov 2021

Sponsor / Collaborator-

NCT04701203 / Active, not recruitingPhase 3

PaTHway TRIAL: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial, With an Open-Label Extension, Investigating the Safety, Tolerability and Efficacy of TransCon PTH Administered Subcutaneously Daily in Adults With Hypoparathyroidism

During the first 26 weeks of the trial, participants will be randomly assigned to one of two groups: one group will receive TransCon PTH and one group will receive placebo. All subjects will start with a fixed dose of study drug and will be individually and progressively titrated to an optimal dose over a 10 week period, followed by an individualized dosing period up to 16 weeks. TransCon PTH or placebo will be administered as a subcutaneous injection using a pre-filled injection pen. Neither trial participants nor their doctors will know who has been assigned to each group. After the 26 weeks, participants will continue in the trial as part of a long-term extension study. During the extension, all participants will receive TransCon PTH, with the dose adjusted to their individual needs. This is a global trial that will be conducted in, but not limited to, the United States, Canada, Germany, and Denmark.

Start Date16 Feb 2021

Sponsor / Collaborator

Ascendis Pharma Bone Diseases A/S

NCT04009291 / Active, not recruitingPhase 2

PaTH Forward: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial With an Open-Label Extension, Investigating the Safety, Tolerability and Efficacy of TransCon PTH Administered Subcutaneously Daily in Adults With Hypoparathyroidism

During the first four weeks of the trial, participants will be randomly assigned to one of four groups: three groups will receive fixed doses of TransCon PTH and one group will receive placebo. TransCon PTH or placebo will be administered as a subcutaneous injection using a pre-filled injection pen. Neither trial participants nor their doctors will know who has been assigned to each group. After the four weeks, participants will continue in the trial as part of a long-term extension study. During the extension, all participants will receive TransCon PTH, with the dose adjusted to their individual needs. This is a global trial that will be conducted in, but not limited to, the United States, Canada, Germany, Denmark, and Norway.

Start Date27 Aug 2019

Sponsor / Collaborator

Ascendis Pharma A/S

100 Clinical Results associated with Palopegteriparatide

100 Translational Medicine associated with Palopegteriparatide

100 Patents (Medical) associated with Palopegteriparatide

Literatures (Medical) associated with Palopegteriparatide

01 Jan 2022·The Journal of clinical endocrinology and metabolismQ2 · MEDICINE

PaTH Forward: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial of TransCon PTH in Adult Hypoparathyroidism

Q2 · MEDICINE

Article

Author: Pagotto, Uberto ; Karpf, David B ; Rubin, Mishaela ; Vokes, Tamara ; Eriksen, Erik ; Palermo, Andrea ; Brod, Meryl ; Clarke, Bart ; Mourya, Sanchita ; Khan, Aliya A ; Smith, Alden ; Schwarz, Peter ; Shu, Aimee D ; Pihl, Susanne ; Rejnmark, Lars ; Marcocci, Claudio ; Markova, Denka ; Ahmed, Intekhab ; Hofbauer, Lorenz

Abstract:

Context:

Hypoparathyroidism is characterized by insufficient levels of parathyroid hormone (PTH). TransCon PTH is an investigational long-acting prodrug of PTH(1-34) for the treatment of hypoparathyroidism.

Objective:

This work aimed to investigate the safety, tolerability, and efficacy of daily TransCon PTH in adults with hypoparathyroidism.

Methods:

This phase 2, randomized, double-blind, placebo-controlled 4-week trial with open-label extension enrolled 59 individuals with hypoparathyroidism. Interventions included TransCon PTH 15, 18, or 21 µg PTH(1-34)/day or placebo for 4 weeks, followed by a 22-week extension during which TransCon PTH dose was titrated (6-60 µg PTH[1-34]/day).

Results:

By Week 26, 91% of participants treated with TransCon PTH achieved independence from standard of care (SoC, defined as active vitamin D = 0 μg/day and calcium [Ca] ≤ 500 mg/day). Mean 24-hour urine Ca (uCa) decreased from a baseline mean of 415 mg/24h to 178 mg/24h by Week 26 (n = 44) while normal serum Ca (sCa) was maintained and serum phosphate and serum calcium-phosphate product fell within the normal range. By Week 26, mean scores on the generic 36-Item Short Form Health Survey domains increased from below normal at baseline to within the normal range. The Hypoparathyroidism Patient Experience Scale symptom and impact scores improved through 26 weeks. TransCon PTH was well tolerated with no treatment-related serious or severe adverse events.

Conclusion:

TransCon PTH enabled independence from oral active vitamin D and reduced Ca supplements (≤ 500 mg/day) for most participants, achieving normal sCa, serum phosphate, uCa, serum calcium-phosphate product, and demonstrating improved health-related quality of life. These results support TransCon PTH as a potential hormone replacement therapy for adults with hypoparathyroidism.

01 Dec 2021·Journal of patient-reported outcomes

Psychometric validation of the Hypoparathyroidism Patient Experience Scales (HPES)

Article

Author: Brod, Meryl ; Gianettoni, Jill ; Shu, Aimee ; Smith, Alden ; Lin, Zhengning ; Markova, Denka ; McLeod, Lori ; Mourya, Sanchita

Abstract:

Background:

Hypoparathyroidism (HP) is a rare endocrine disorder characterized by absent or inappropriately low levels of circulating parathyroid hormone with associated significant physical and cognitive symptoms. This study evaluated the psychometric properties of the Hypoparathyroidism Patient Experience Scales (HPES), which were developed as disease-specific, patient-reported outcome (PRO) measures to assess the symptoms and impacts associated with HP in adults.

Methods:

Data from a non-interventional, observational study (N = 300) and a Phase 2 clinical trial (N = 59) were used in the psychometric evaluation. Observational and trial assessments included: an online validation battery (baseline or screening) and retest (approximately 2 weeks after baseline or screening). In the trial, the primary efficacy endpoint was assessed at week 4 through re-administration of the HPES and validation battery subset. The observational study’s larger sample size allowed for evaluation of the HPES descriptive properties, scoring algorithm, test-retest reliability, and construct validity. The trial data examined responsiveness, meaningful within-patient change estimates, and treatment impact on HPES scores.

Results:

Demographic and self-reported medical characteristics results were similar across the 2 studies. Factor analysis confirmed domains in the HPES-Symptom (n = 2) and HPES-Impact (n = 4). For both measures, total and domain scores demonstrated acceptable reliability and validity for both the observational and trial samples. Internal consistency evidence was strong. Test-retest reliability estimates generally approached the recommended 0.70 threshold. The construct validity correlations with other PRO measures were mainly as hypothesized, thus supporting the HPES scores and constructs. Mean scores for both measures also differed as anticipated and significantly across known-groups, thus providing evidence for the scores discriminating between meaningful groups. Trial results supported both HPES total and domain scores’ ability to detect change. The difference in mean total and domain scores for both measures demonstrated statistically significant improvements for TransCon PTH compared to placebo treated subjects despite the small sample and a short 4-week duration on fixed, non-optimized doses.

Conclusions:

The HPES were found to be conceptually sound with adequate evidence supporting their reliability and validity. Incorporation of the HPES into clinical and research settings will help to further elucidate and assess the patient experience of living with HP and identify treatment differences.

01 Dec 2020·Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research

Efficacy and Safety of Parathyroid Hormone Replacement With TransCon PTH in Hypoparathyroidism: 26-Week Results From the Phase 3 PaTHway Trial

Article

Author: Vokes, Tamara ; Abbott, Lisa G ; Gagnon, Claudia ; Ukena, Jenny ; Eng, Walter Frank ; Khan, Aliya A ; Sibley, Christopher T ; Rubin, Mishaela R ; Clarke, Bart L ; Schwarz, Peter ; Rejnmark, Lars ; Shu, Aimee D ; Marcocci, Claudio ; Kohlmeier, Lynn ; Smith, Alden R ; Pihl, Susanne ; An, Xuebei ; Palermo, Andrea ; Shoback, Dolores M ; Hofbauer, Lorenz C

ABSTRACT:

Conventional therapy for hypoparathyroidism consisting of active vitamin D and calcium aims to alleviate hypocalcemia but fails to restore normal parathyroid hormone (PTH) physiology. PTH replacement therapy is the ideal physiologic treatment for hypoparathyroidism. The double-blind, placebo-controlled, 26-week, phase 3 PaTHway trial assessed the efficacy and safety of PTH replacement therapy for hypoparathyroidism individuals with the investigational drug TransCon PTH (palopegteriparatide). Participants (n = 84) were randomized 3:1 to once-daily TransCon PTH (initially 18 μg/d) or placebo, both co-administered with conventional therapy. The study drug and conventional therapy were titrated according to a dosing algorithm guided by serum calcium. The composite primary efficacy endpoint was the proportion of participants at week 26 who achieved normal albumin-adjusted serum calcium levels (8.3–10.6 mg/dL), independence from conventional therapy (requiring no active vitamin D and ≤600 mg/d of calcium), and no increase in study drug over 4 weeks before week 26. Other outcomes of interest included health-related quality of life measured by the 36-Item Short Form Survey (SF-36), hypoparathyroidism-related symptoms, functioning, and well-being measured by the Hypoparathyroidism Patient Experience Scale (HPES), and urinary calcium excretion. At week 26, 79% (48/61) of participants treated with TransCon PTH versus 5% (1/21) wiplacebo met the composite primary efficacy endpoint (p < 0.0001). TransCon PTH treatment demonstrated a significant improvement in all key secondary endpoint HPES domain scores (all p < 0.01) and the SF-36 Physical Functioning subscale score (p = 0.0347) compared with placebo. Additionally, 93% (57/61) of participants treated with TransCon PTH achieved independence from conventional therapy. TransCon PTH treatment normalized mean 24-hour urine calcium. Overall, 82% (50/61) treated with TransCon PTH and 100% (21/21) wiplacebo experienced adverse events; most were mild (46%) or moderate (46%). No study drug-related withdrawals occurred. In conclusion, TransCon PTH maintained normocalcemia while permitting independence from conventional therapy and was well-tolerated in individuals with hypoparathyroidism. © 2022 The Authors. Journal of Bone and Mineral Research published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research (ASBMR).AbstractTransCon PTH is an investigational once-daily prodrug providing sustained release of active PTH designed to maintain stable PTH levels in the physiological range for 24 hours/day. The PaTHway trial met all primary and key secondary endpoints with statistically significant differences from placebo. Most adverse events (AEs) were mild/moderate. Injection-site reactions and headaches were the most common treatment-related AEs.

News (Medical) associated with Palopegteriparatide

18 Jun 2024

·www.sciencedaily.com

Promising drug target for treating osteoporosis

Osteoporosis or the weakening of bones makes the aging population vulnerable to fractures and a decreased quality of life. The parathyroid hormone (PTH)-derived peptide -- teriparatide has demonstrated strong bone promoting effects. However, it is also to known to exert bone-resorbing effects. A new study uncovers a novel PTH-inducible target gene -- Gprc5a which suppresses the proliferation and differentiation of 'osteoblasts' or bone-forming cells, and may serve as a therapeutic target in the treatment of osteoporosis. Osteoporosis is a skeletal condition that leads to the weakening of bones, making them porous, fragile, and prone to breakage. A whopping 8.9 million fractures are caused by osteoporosis annually, with one fracture occurring every three seconds! The aging population is the most vulnerable to primary osteoporosis, given, their frailty, and often, requires long-term therapy and support. Advances in healthcare and the corresponding rise in the aging population have put a strain on available resources, underscoring the need for effective therapies against osteoporosis. Induction of parathyroid hormone (PTH) signaling using the PTH-derived peptide -- teriparatide, has demonstrated strong bone-promoting effects in patients with osteoporosis. These effects are mediated by osteogenesis, the process of bone formation involving the differentiation and maturation of bone-forming cells called osteoblasts. However, PTH induction is also associated with the differentiation of macrophages into osteoclasts, which are specialized cells responsible for bone resorption. Although, bone remodeling by osteoblasts and osteoclasts is crucial for maintaining skeletal health, PTH-induced osteoclast differentiation can decrease treatment efficacy in patients with osteoporosis. However, precise molecular mechanisms underlying the dual action of PTH signaling in bone remodeling are not well understood. To bridge this gap, Professor Tadayoshi Hayata and Ms. Chisato Sampei, from Tokyo University of Science, along with their colleagues, conducted a series of experiments to identify druggable target genes downstream of PTH signaling in osteoblasts. Explaining the rationale behind their study published on 20 May, 2024, in the Journal of Cellular Physiology, corresponding author, Prof. Hayata says, "In Japan, it is estimated that 12.8 million people, or one in ten people, suffer from osteoporosis, which can significantly deteriorate their quality of life. Teriparatide is classified as a drug that promotes bone formation, but it also promotes bone resorption, which may limit bone formation. However, the full scope of its pharmacological action remains unknown." The researchers treated cultured mouse osteoblast cells and mice with teriparatide. They then assessed gene expression changes induced by PTH in both the cultured cells and bone cells isolated from the femurs of the treated animals, using advanced RNA-sequencing analysis. Among several upregulated genes, they identified a novel PTH-induced gene -- 'Gprc5a', encoding an orphan G protein-coupled receptor, which has been previously explored as a therapeutic target. However, its precise role in osteoblast differentiation had not been fully understood. PTH induction has been known to activate the cyclic adenosine monophosphate (cAMP) and protein kinase C (PKC) signaling pathways. Interestingly, the team found that in addition to PTH induction, activation of cAMP and PKC also resulted in overexpression of Gprc5a, albeit to a lesser extent, underscoring the potential involvement of other molecular pathways. Notably, upregulation of Gprc5a was suppressed upon inhibition of transcription, but, remained unaffected upon suppressing protein synthesis, suggesting that Gprc5a could be transcribed early on in response to PTH signaling and serves as a direct target gene. Furthermore, the researchers examined the effect of Gprc5a downregulation on osteoblast proliferation and differentiation. Notably, while PTH induction alone did not affect cell proliferation, Gprc5a knockdown resulted in an increase in the expression of cell-cycle-related genes and osteoblast differentiation markers. These findings suggest that Gprc5a suppresses osteoblast proliferation and differentiation. Diving deeper into the molecular mechanisms underlying the effects of Gprc5a, in PTH-induced osteogenesis, the researchers identified Activin receptor-like kinase 3 (ALK3) -- a bone morphogenetic protein (BMP) signaling pathway receptor, as an interacting partner of Gprc5a. In line with their speculation, overexpression of Gprc5a indeed, led to suppression of BMP signaling via receptors including ALK3. Overall, these findings reveal that Gprc5a -- a novel inducible target gene of PTH, negatively regulates osteoblast proliferation and differentiation, by partially suppressing BMP signaling. Gprc5a can thus, be pursued as a novel therapeutic target while devising treatments against osteoporosis. The study sheds light on the complex process of bone remodeling and explains the bone-promoting and bone-resorbing effects of PTH signaling. "Our study shows Gprc5a may function as a negative feedback factor for the bone formation promoting effect of teriparatide. Suppressing Gprc5a function may, therefore, increase the effectiveness of teriparatide in non-responding patients. In the future, we hope that our research will lead to improved quality of life and healthy longevity for people suffering from osteoporosis," concludes Prof. Hayata. We too hope that these findings pave the way for the development of effective therapies that can improve the lives of people living with osteoporosis.

03 Jun 2024

·www.globenewswire.com

Entera Bio Reports Phase 1 Clinical Data of First-in-Class, Oral PTH(1-34) Peptide Candidate (EB612) for Patients with Hypoparathyroidism at ENDO 2024

JERUSALEM, June 03, 2024 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX), (“Entera” or the “Company”) a leader in the development of orally delivered peptides and small therapeutic proteins, today announced Phase 1 clinical data for its hypoparathyroidism focused investigational program, EB612, as presented on June 1st at the Endocrine Society ENDO 2024 Annual Meeting. Entera’s EB612 program aims to provide the first oral PTH daily tablet hormone replacement therapy for patients suffering from hypoparathyroidism. Late stage investigational PTH replacement treatments include TransCon PTH (palopegteriparatide) by Ascendis Pharma A/S and eneboparatide (AZP-3601) by Amolyt Pharma. Both these modalities require patients to administer injections every day. Entera previously published positive Phase 2a study results in hypoparathyroid patients with four times a day (QID) regimen (Ish-Shalom, JBMR 2021) of EB612. The data reported from this Phase 1 clinical study include pharmacokinetic (PK), pharmacodynamic (PD) and safety results from the application of a new generation of Entera’s N-Tab™ technology platform and EB612, the active peptide fragment 1-34 of the N-terminal region of human parathyroid hormone (teriparatide) dosed twice a day (BID). Significant systemic exposure was reported following both administrations of EB612 tablets. Aside from positive PK measures, sustainable PD effects were reported, including serum levels of calcium (albumin corrected), phosphate, and 1,25(OH)2-Vitamin D (reaching +3.9%, -20.8%, and +73.2% change on average from baseline, respectively) and decreased endogenous serum PTH(1-84) (reaching -43.0% change on average from baseline). There were no treatment-emergent Adverse Events of hypercalcemia reported. There were no treatment-emergent Serious AEs. The only Study Drug-Related AE was mild headache, reported in two out of fifteen subjects. No significant findings were observed in blood and urine lab tests. All vital signs were within the normal range. “The encouraging findings from this Phase 1 study reaffirm the ability of our N-Tab™ platform to develop simple oral tablet treatments of important peptide therapeutics. Here we suggest that a BID administration of our unmodified PTH(1-34) peptide may provide a viable alternative for patients with hypoparathyroidism who require a peptide replacement therapy for life and are intolerant, adverse or cannot access a daily injectable product,” said Miranda Toledano, Chief Executive Officer at Entera. The poster can be found on the Entera Bio website (Link to poster) About Entera Bio Entera is a clinical stage company focused on developing oral peptide or protein replacement therapies for significant unmet medical needs where an oral tablet form holds the potential to transform the standard of care. The Company leverages on a disruptive and proprietary technology platform (N-Tab™) and its pipeline includes five differentiated, first-in-class oral peptide programs, expected to enter the clinic (Phase 1 to Phase 3) by 2025. The Company’s most advanced product candidate, EB613 (oral PTH (1-34)), is being developed as the first oral, osteoanabolic (bone building) once-daily tablet treatment for post-menopausal women with low BMD and high-risk osteoporosis, with no prior fracture. A placebo controlled, dose ranging Phase 2 study of EB613 tablets (n= 161) met primary (PD/bone turnover biomarker) and secondary endpoints (BMD). Entera is preparing to initiate a Phase 3 registrational study for EB613 pursuant to the FDA’s qualification of a quantitative BMD endpoint which is expected to occur by January 2025. The EB612 program is being developed as the first oral PTH(1-34) tablet peptide replacement therapy for hypoparathyroidism. Entera is also developing the first oral oxyntomodulin, a dual targeted GLP1/glucagon peptide, in tablet form for the treatment of obesity; and first oral GLP-2 peptide tablet as an injection-free alternative for patients suffering from rare malabsorption conditions such as short bowel syndrome in collaboration with OPKO Health. For more information on Entera Bio, visit www.enterabio.com or follow us on LinkedIn, Twitter, Facebook, Instagram. Cautionary Statement Regarding Forward Looking Statements Various statements in this press release are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements (other than statements of historical facts) in this press release regarding our prospects, plans, financial position, business strategy and expected financial and operational results may constitute forward-looking statements. Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward-looking statements. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Forward-looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved. Important factors that could cause actual results to differ materially from those reflected in Entera’s forward-looking statements include, among others: changes in the interpretation of clinical data; results of our clinical trials; the FDA’s interpretation and review of our results from and analysis of our clinical trials; unexpected changes in our ongoing and planned preclinical development and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates; the potential disruption and delay of manufacturing supply chains; loss of available workforce resources, either by Entera or its collaboration and laboratory partners; impacts to research and development or clinical activities that Entera may be contractually obligated to provide; overall regulatory timelines; the size and growth of the potential markets for our product candidates; the scope, progress and costs of developing Entera’s product candidates; Entera’s reliance on third parties to conduct its clinical trials; Entera’s expectations regarding licensing, business transactions and strategic collaborations; Entera’s operation as a development stage company with limited operating history; Entera’s ability to continue as a going concern absent access to sources of liquidity; Entera’s ability to obtain and maintain regulatory approval for any of its product candidates; Entera’s ability to comply with Nasdaq’s minimum listing standards and other matters related to compliance with the requirements of being a public company in the United States; Entera’s intellectual property position and its ability to protect its intellectual property; and other factors that are described in the “Cautionary Statements Regarding Forward-Looking Statements,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Entera’s most recent Annual Report on Form 10-K filed with the SEC, as well as the company’s subsequently filed Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. There can be no assurance that the actual results or developments anticipated by Entera will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Entera. Therefore, no assurance can be given that the outcomes stated or implied in such forward-looking statements and estimates will be achieved. Entera cautions investors not to rely on the forward-looking statements Entera makes in this press release. The information in this press release is provided only as of the date of this press release, and Entera undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law.

Phase 1Phase 2Clinical ResultPhase 3

15 May 2024

·firstwordpharma.com

Ascendis’ hormone replacement therapy hit with three-month FDA review delay

Ascendis Pharma is facing another setback on its journey to win approval for TransCon PTH (palopegteriparatide) to treat hypoparathyroidism. The FDA on Tuesday extended its review of the hormone replacement therapy by three months and now expects to make a decision by August 14.According to Ascendis, the FDA needs more time to review new information submitted by the company, which constituted a major amendment to its application for TransCon PTH. “We have responded to all requests received to date from the FDA and will work with the agency as they continue their review,” said CEO Jan Mikkelsen.The delay follows a complete response letter from the US regulator last year, which cited issues with the manufacturing control strategy for variability of delivered dose in the TransCon PTH drug/device combo, but did not raise any concerns with the investigational drug’s efficacy or safety.Ascendis’ application for TransCon PTH includes data from the Phase III PaTHway and Phase II PaTH Forward trials, which showed that 79% and 86% of treated patients, respectively, achieved normalisation of serum calcium and independence from conventional therapy at six months of treatment.

Phase 2Phase 3Clinical Result

100 Deals associated with Palopegteriparatide

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R&D Status

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Indication	Country/Location	Organization	Date
Hypoparathyroidism	EU	Ascendis Pharma Bone Diseases A/S	17 Nov 2023
Hypoparathyroidism	IS	Ascendis Pharma Bone Diseases A/S	17 Nov 2023
Hypoparathyroidism	LI	Ascendis Pharma Bone Diseases A/S	17 Nov 2023
Hypoparathyroidism	NO	Ascendis Pharma Bone Diseases A/S	17 Nov 2023

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04701203 (PaTHway, GlobeNewswire) Manual	Phase 3	Hypoparathyroidism	82	TransCon PTH (palopegteriparatide)	nfnfvfbwai(ttfryrljtf) = oqhwfonayt mwsiwcfzbc (sybxwkdjaf ) View more	Positive	13 May 2024
				TransCon PTH (palopegteriparatide) (eGFR < 60 mL/min/1.73m2)	nfnfvfbwai(ttfryrljtf) = jghmvpbyyw mwsiwcfzbc (sybxwkdjaf ) View more
NCT04009291 (PaTHway \| PaTH Forward, CTgov)	Phase 2	Hypoparathyroidism	59	TransCon PTH (TransCon PTH 15 mcg)	vsjccjtwrd(ciosuydflh) = cprbzqnmvu lwyaqajiyg (xvyelawcby, yyseiwbjxp - chrhwqwxzg) View more	-	01 Sep 2023
				TransCon PTH (TransCon PTH 18 mcg)	vsjccjtwrd(ciosuydflh) = tufdvluayu lwyaqajiyg (xvyelawcby, euveqkvjye - goocfnycza) View more
NCT04009291 (PaTH Forward, Corporate Publications) Manual	Phase 2	-	57	TransCon™ PTH	tuhotuiyhj(anmjopbqqf) = odlwhjqugl ybzpnnefhq (kzjtnoxwsy ) View more	Positive	12 Sep 2022
NCT04701203 (Corporate Publications) Manual	Phase 3	Hypoparathyroidism	82	Palopegteriparatide	bxpygbozup(mlhpdqrpsk) = rvggrmqnhi qsnikeddle (jhuvywigtx, 66.3 ~ 88.1) View more	Positive	13 Mar 2022
				Placebo	bxpygbozup(mlhpdqrpsk) = ytjzewjakt qsnikeddle (jhuvywigtx, 0.1 ~ 23.8) View more
NCT04009291 (PaTH Forward, Pubmed \| J Clin Endocrinol Metab) Manual	Phase 2	Hypoparathyroidism	59	TransCon PTH	lnhkvjsijk(mxvkaetwfm) = spjhyuibaa edzdumzhcw (apmrhgndpl )	Positive	04 Aug 2021
				TransCon PTH 18 µg PTH(1-34)/day	-

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