prifemilast (HPP737) / vTv Therapeutics, Newsoara Biopharma, cAMPfield Therapeutics - LARVOL DELTA

Graham Heap Joins cAMPfield as R&D President to Advance Prifemilast Phase 2 Program (citybiz) - "The leadership buildout reflects cAMPfield’s focus on strengthening its development capabilities as it moves from early clinical work toward larger international studies. The company is positioning prifemilast, a once-daily oral phosphodiesterase 4 (PDE4) inhibitor, in a competitive inflammatory bowel disease market where demand remains strong for effective oral therapies that can offer durable disease control with improved tolerability."

New P2 trial • Crohn's disease • Ulcerative Colitis

HPP737 in Adult Patients With Plaque Psoriasis (clinicaltrials.gov) - P3 | N=607 | Completed | Sponsor: Newsoara Biopharma Co., Ltd.

New P3 trial • Dermatology • Immunology • Psoriasis

Safety and Efficacy of HPP737 in Adult Patients With Plaque Psoriasis (clinicaltrials.gov) - P2 | N=123 | Completed | Sponsor: Newsoara Biopharma Co., Ltd.

New P2 trial • Dermatology • Immunology • Psoriasis

HPP737 in Adult Patients With Moderate-to-severe Plaque Psoriasis. (clinicaltrials.gov) - P3 | N=515 | Completed | Sponsor: Newsoara Biopharma Co., Ltd.

New P3 trial • Dermatology • Immunology • Psoriasis

cAMPfield Launches With $180 Million Series A to Advance Prifemilast, a Potential Best-in-Class Oral Therapy for IBD (PRNewswire) - "cAMPfield initiating global Phase 2 trials in moderate-to-severe ulcerative colitis and Crohn's disease."

Financing • New P2 trial • Crohn's disease • Ulcerative Colitis

Pharmacokinetics, Safety and Tolerability of HPP737, a Novel PDE4 Inhibitor, in Healthy Chinese Participants: Phase I Study. (PubMed, Drug Des Devel Ther) - "HPP737 showed a favorable pharmacokinetics profile suitable for once-daily administration and was well-tolerated in healthy Chinese participants, with a notably low incidence of CNS-related effects-a common limitation of existing PDE4 inhibitors. Collectively, these findings support the continued clinical development of HPP737 as a potential treatment for COPD."

Clinical • Journal • P1 data • PK/PD data • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

China's Newsoara pens $135M deal for remaining rights to vTv's inflammation drug (FierceBiotech) - "Having already secured regional rights to vTv Therapeutics’ inflammation drug, China’s Newsoara is fronting $20 million to take ownership of the clinical-stage asset across the rest of the world. The therapy in question is HPP737, a phosphodiesterase type 4 (PDE4) inhibitor that vTv has taken into phase 1 development to treat psoriasis. Newsoara originally secured the rights for the drug in China and various other Pacific Rim countries in 2018 for an undisclosed price....The new deal means North Carolina-based vTv could also be in line for up to $50 million in development milestones, $65 million in sales milestones and tiered royalties on sales should Newsoara manage to get HPP737 to market."

Licensing / partnership • Psoriasis

HPP737 Substance Balance Study in Human (clinicaltrials.gov) - P=N/A | N=8 | Not yet recruiting | Sponsor: Newsoara Biopharma Co., Ltd.

New trial • Dermatology • Immunology • Psoriasis

vTv Therapeutics Announces Restructuring to Prioritize its Lead Program and Focus Operations (Yahoo Finance) - "Due to its shift in strategic focus, the Company:...Paused vTv’s development activities on HPP737, a PDE4 inhibitor for treatment of psoriasis, while it evaluates strategic options; and Continues to support the development of its partnered programs."

Trial suspension • Immunology • Psoriasis

vTv Therapeutics Announces Results of Multiple Ascending Dose Study and Development Plan for HPP737, an Oral PDE4 Inhibitor for the Treatment of Psoriasis (GlobeNewswire) - P1, N=84; NCT04714294; Sponsor: Newsoara Biopharma Co., Ltd.; "vTv Therapeutics Inc...announced results of a multiple ascending dose study evaluating HPP737, an orally administered phosphodiesterase type 4 ('PDE4') inhibitor, in healthy adults...Dose escalation up to 20mg/day demonstrated approximate dose proportional increases in exposure, while maintaining a favorable safety and tolerability profile with no dose limiting safety or tolerability findings observed. There were no serious adverse events and no discontinuations due to treatment emergent adverse events...vTv plans to file an IND application later this year for a 12-week Phase 2 clinical trial evaluating the safety and efficacy of HPP737 in patients with moderate to severe psoriasis with study initiation targeted for early 2022."

New P2 trial • P1 data • Immunology • Psoriasis

vTv Therapeutics Announces 2021 Second Quarter Financial Results and Provides Corporate Update (GlobeNewswire) - "Psoriasis: Multiple Ascending Dose Study with HPP737...We expect to report the results from this study in the third quarter. Phase 2 Study Planning. The Company is planning a phase 2 clinical trial of HPP737 in patients with psoriasis. We are discussing the proposed study design with the FDA during the third quarter and expect to begin the study late in the fourth quarter of 2021 or early in the first quarter of 2022...R&D Expenses: Research and development expenses were $2.4 million and $3.1 million for the three months ended June 30, 2021 and March 31, 2021, respectively...decrease in spending for our study of HPP737 in psoriasis."

Commercial • New P2 trial • P1 data • P2 data • Immunology • Psoriasis

vTv Therapeutics to Participate at the 6th World Psoriasis & Psoriatic Arthritis Conference with Poster Presentation on HPP737 (GlobeNewswire) - "vTv Therapeutics Inc...announced that it will be presenting data from the clinical development of HPP737 as a treatment for psoriasis in a poster presentation at the 6th World Psoriasis & Psoriatic Arthritis Conference held virtually June 30 – July 3, 2021 in Stockholm, Sweden."

Clinical data • PK/PD data • Immunology • Psoriasis

vTv Therapeutics Announces 2021 First Quarter Financial Results and Provides Corporate Update (GlobeNewswire) - "Multiple Ascending Dose Study with HPP737...This phase 1 study is expected to report topline results in the third quarter and will inform dose selection for a planned phase 2 study in psoriasis...R&D Expenses: Research and development expenses were $3.1 million and $2.5 million for the three months ended March 31, 2021 and December 31, 2020, respectively. This increase of $0.6 million was driven primarily by the increase in spending for our study of HPP737 in psoriasis."

Commercial • P1 data • Immunology • Psoriasis

vTv Therapeutics Announces Initiation of Multiple Ascending Dose Study of HPP737, an Oral PDE4 Inhibitor for the Treatment of Psoriasis (GlobeNewswire) - P1, N=NA; "...Newsoara Biopharma, has advanced HPP737 into phase 2 with the initiation of a proof of concept study in chronic obstructive pulmonary disease (COPD) in China. The phase 2 study in COPD follows the completion of a phase 1 pharmacokinetic bridging study in which HPP737 was well tolerated with no dose limiting safety or tolerability findings and little or no gastrointestinal distress."

P1 data • Trial status • Chronic Obstructive Pulmonary Disease • Respiratory Diseases

vTv Therapeutics Announces Initiation of Multiple Ascending Dose Study of HPP737, an Oral PDE4 Inhibitor for the Treatment of Psoriasis (GlobeNewswire) - "vTv Therapeutics Inc...announced the initiation of a phase 1 multiple ascending dose study evaluating...HPP737, to assess the pharmacokinetics, pharmacodynamics, safety and tolerability of HPP737 in healthy adult volunteers. The Company expects to complete the study in Q2 2021...to inform dose selection for a phase 2 study in psoriasis which is planned for later this year."

New P2 trial • Trial completion date • Trial status • Immunology • Psoriasis

Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers (clinicaltrials.gov) - P1; N=84; Recruiting; Sponsor: Newsoara Biopharma Co., Ltd.

Clinical • New P1 trial

vTv Therapeutics Announces 2020 Third Quarter Financial Results and Update (BioSpace) - "Psoriasis: Multiple Ascending Dose Study with HPP737: The Company is planning a phase 1 multiple ascending dose study to assess the safety, tolerability, and pharmacokinetic profile of HPP737, a PDE4 inhibitor, in healthy volunteers. vTv expects to initiate the study in the first quarter of 2021 and to report topline results in the second quarter of 2021."

New P1 trial • P1 data • Trial initiation date • Immunology • Psoriasis

vTv Therapeutics Announces Common Stock Purchase Agreement for up to $47 Million with Lincoln Park Capital (GlobeNewswire) - "vTv Therapeutics...today announced it has entered into a common stock purchase agreement ('Purchase Agreement') for up to $47 million with Lincoln Park Capital Fund, LLC ('LPC'), a Chicago-based institutional investor...'The LPC financing will help us reach a number of potential value-driving events over the next six to nine months...conducting a multiple-ascending dose study of HPP737 as part of a development program of the product as an oral therapy for psoriasis.'"

Licensing / partnership • New trial • Immunology • Psoriasis