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Corbus Pharmaceuticals Inc. (NASDAQ:CRBP) Publishes Phase 2b Lenabasum Study In Cystic Fibrosis In The Cystic Fibrosis Journal

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Corbus Pharmaceuticals Inc. (NASDAQ:CRBP) has announced its baseline patient disease characteristics and demographics in the Phase 2b lenabasum study in cystic fibrosis. The company has also indicated that the last patient has completed their last visit in the study.

Phase 2b lenabasum CF study topline results expected in Q3 2020

The drug development company published the information in the electronic appendage of the Journal of Cystic Fibrosis concerning this year’s 43rd European Cystic Fibrosis Conference. The publication’s abstract title was, “Patient demographics and baseline disease characteristics in a multicentre, randomized, double-blind, placebo-controlled phase 2b study of lenabasum, a selective cannabinoid receptor type 2 agonist, in cystic fibrosis.”

Topline study results readout is expected in Q3 2020. Corbus CEO Yuval Cohen acknowledged the efforts of clinical investigators, company staff as well as the subjects for the commitment and dedication to finalize the study in time despite uncertainties of COVID-19. The CEO thanked the Cystic Fibrosis Foundation for its financial support and expertise in facilitating the study design as well as its execution.

Phase 2b CF study enrolled 426 subjects

Around 426 subjects were enrolled in the Phase 2b multinational study, which was evaluating the safety and efficacy of lenabasum in the treatment of cystic fibrosis. The study was a randomized, double-mask, placebo-controlled trial where subjects were dosed with 5mg of lenabasum twice daily and 20mg of lenabasum twice daily or placebo twice daily. The study lasted around 28 weeks plus a 4-week safety follow-up after active treatment.

The study’s primary efficacy endpoint was pulmonary exacerbation (PEx) event rate. On the other hand, the secondary efficacy endpoint outcomes included other PEx measures, changes in forces expiratory volume in a second (FEV1, percentage predicted as well as changes in Cystic Fibrosis Questionnaire-Revised respiratory area score.

Corbus received a Development Award from the Cystic Fibrosis Foundation of around $25 million, which was used to fund the study.  The FDA has granted lenabasum Fast Track designation and Orphan Drug designation for cystic fibrosis treatment in the US as well as Orphan Designation from the EMA.

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GW Pharmaceuticals Plc (NASDAQ:GWPH) Reports $148.2 Million In Revenues In Q4 2020

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GW Pharmaceuticals Plc (NASDAQ:GWPH) reported $148.2 million (up 35.83% YoY) in total revenues in Q4 2020. Its full-year revenues are $572.2 million.

CEO of GW Pharmaceuticals, Justin Gover, said the company is pleased to report strong performance in 2020. It is on the backdrop of a significant surge in Epidyolex sales by over 70% last year despite the ongoing coronavirus. The company expects to realize strong growth in 2021 by improving performance in Europe and the US.

Phase 3 clinical studies of nabiximols

GW commenced the Phase-3 clinical study of nabiximols for the treatment of MSS (multiple sclerosis spasticity). To fulfill its commitment given to the patients to develop medicines to address the unmet needs, the company is advancing its robust and diverse neuroscience pipeline using clinical-stage and preclinical stage pipeline candidates.

Signs an accord with Jazz Pharmaceuticals Plc

GW Pharmaceuticals entered an exclusive agreement with Jazz Pharmaceuticals Plc (NASDAQ:JAZZ) on February 3, 2021. Under the agreement, Jazz will acquire GW Pharmaceuticals for $7.2 billion. The deal is subject to the nod of the High Court of Justice of England and Wales and the shareholders of GW Pharmaceuticals and will close in Q2 2021.

Epidyolex to treat Tuberous Sclerosis Complex related seizures

GW Pharmaceuticals announced the receipt of positive opinion for its type II variation application for Epidyolex from EMA (European Medicines Agency) CHMP (Committee for Medicinal Products for Human Use). Epidyolex will be used to treat seizures related to TSC (Tuberous Sclerosis Complex) for patients aged two years or older.

The condition TSC causes tumor growth in vital organs like the heart, skin, brain, lungs, kidneys, and eyes of your body. It is easily diagnosed in childhood. Over 90% of the patients with TSC usually experience Epilepsy. Around 60% of those patients with seizures do not respond to traditional Epilepsy medicines. The positive opinion from CHMP brings GW Pharmaceuticals a step closer to provide a life-improving treatment with its Epidyolex.

Several patients in Europe are suffering from this debilitating health condition. GW Pharmaceuticals innovative medicine – Epidyolex is an alternative treatment to control seizures adequately. CMO of GW Pharmaceuticals, Volker Knappertz, said the company is excited to demonstrate the potential of Epidyolex in patients with seizures-related TSC.

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Acreage Holdings Inc (OTCMKTS:ACRDF) Appoints Steve Goertz As CFO: Will Report Q4 2020 Results On March 9, 2021

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Acreage Holdings Inc (OTCMKTS:ACRDF) appointed Steve Goertz as a Chief Financial Officer with effect from April 2, 2021. The new recruitment is on the backdrop of the resignation of CFO – Glen Leibowitz.

Glen increases turnover to $115 million

Glen played a vital role in positioning Acreage as a key player in the cannabis industry. He will stay with the company for some time to ensure the smooth transformation of financial activities. CEO of Acreage, Peter Caldini, said Glen is instrumental in improving the company’s annual revenues to $115 million from just a little lower than $10 million.

Steve will contribute over 25 years of experience

Steve brings over 25 years of experience in strategic planning, capital markets, and financial markets in many industries. His previous roles include CFO in SGSCO. He also worked as CFO at Goeasy Ltd and transformed it to NBFSO (Non-bank financial services organization) from hard goods’ retail business.

Steve also gained significant expertise in cannabis capital markets when working at Bespoke Capital Acquisition Corp for 14 months. Peter said he is pleased to welcome Steve to Acreage, and he is ideal to lead accounting and financial functions. Steve will play a key role in supporting the growth strategies of Acreage.

Agreed to sell Florida operations

High Street Capital Partners, LLC, a subsidiary of Acreage, entered a pact to sell common and issued common shares of Acreage Florida Inc. The company will mobilize $60 million from the proposed sale to Red White and Bloom Brands, Inc.

Acreage Florida’s assets include a processing facility, a license for operating medical marijuana dispensaries, a cultivation facility based in Florida. Sanderson, Florida-based property, is also included in the sale.

Peter said the company’s decision to divest Florida operations will concentrate on core markets and turn to profitability. It will also make ways for cash generation in the long term.

Peter further said the company can strengthen its balance sheet and expedite the expansion of cultivation projects. The initiative will also help it inaugurate additional dispensaries to sell adult-use cannabis in states like New Jersey and Illinois.

Acreage will publish Q4 2020 and full-year revenues on March 9, 2021. The company will also host a conference call at 8:30 AM EST on March 2021.

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InMed Pharmaceuticals Inc (NASDAQ:INM) Reports Tolerability And Strong Safety Data For INM-755 In Q2 2021

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InMed Pharmaceuticals Inc (NASDAQ:INM) achieved several risk-mitigating and value-adding milestones in IntegraSyn production approach and therapeutic programs. Eric A. Adams, CEO of InMed, said the company now possesses tolerability and strong safety data for its INM-755. In 2021, the company will use this data to commence efficacy and safety trials in patients with Epidermolysis Bullosa (EB).

INM-755 to cure Epidermolysis Bullosa

InMed reported topline results from the Phase 1 clinical study (study 101) of INM-755-101-HV on November 25, 2020.

The company conducted a double-blind, vehicle-controlled, randomized phase 1 clinical trial to examine the tolerability and safety of INM-755 cream on 22 healthy patient’s skin over two weeks. No serious adverse effects or systemic effects are reported on the skin of volunteers during the trial.

InMed reported topline results of Study 102 that involves INM-755 cream on January 8, 2021. Study 102 is conducted on eight adult volunteers for two weeks. In the clinical study, the cream is applied to epidermal wounds. No adverse or serious effects are reported in the clinical study.

With positive data obtained from the Phase 1 clinical study involving INM-755 cream, InMed is preparing to apply for a phase 2 clinical trial to examine the efficacy and safety in patients with EB in H1 2021. The company will commence patient enrollment for the Phase 2 clinical trial in H2 2021.

Secures a global and exclusive license

InMed secured a global and exclusive license for its MiDROPS eyedrop delivery technology from EyeCRO LLC. It is targeting topical and effective administration of cannabinoid variants, cannabinoids, and analogs to the eyes of patients. It helps to cure ocular diseases like glaucoma.

Mobilizes $8 million

InMed mobilized $8 million by issuing 1.78 million shares, each at $4.5 to the public on November 16, 2020. The company also entered a pact on February 5, 2021, to issue common shares, each at $4.5, to institutional investors to generate funds of $4.5 million. It will use the proceeds for general corporate needs, clinical development programs, and working capital needs.

InMed narrowed the net loss to $2.243 million in Q2 2021 from $2.49 million in Q2 2020.

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