The Daily Biotech Pulse: INmune Bio's Planned Alzheimer's Trial On FDA Hold, Caladrius Stops Enrollment In Heart Disease Study, BiomX Restructures

Zinger Key Points
  • Caladrius Biosciences suspended patient enrollment in its Phase 2b FREEDOM Trial of Xowna for coronary microvascular dysfunction.
  • The FREEDOM trial enrolled approximately one-third of the targeted 105 patients.

Here's a roundup of top developments in the biotech space over the last 24 hours:

Stocks In Focus

INmune Bio Planned Midstage Alzheimer's Trial Put On FDA Hold

The FDA has requested additional information on the Chemistry Manufacturing and Controls of the newly manufactured INmune Bio Inc's INMB XPro1595. 

As part of the communication, the FDA placed the company's Investigational New Drug application for the Phase 2 trial of XPro in Alzheimer's Disease on clinical hold. 

INmune plans to provide additional updates pending discussion with the FDA. The Phase 2 trial of XPro remains open in Australia and continues to enroll patients.

Shares are down 27.2% at $5.29 during the premarket session.

Caladrius Biosciences Stops Enrollment In Midstage Heart Disease Study

Caladrius Biosciences Inc CLBS suspended patient enrollment in its Phase 2b FREEDOM Trial of Xowna for coronary microvascular dysfunction. 

The FREEDOM trial enrolled approximately one-third of the targeted 105 patients, and at this rate, more than four years would likely be required to reach the primary endpoint follow-up at six months post-treatment for all subjects. 

The interim analysis is expected to be completed in August 2022.

Ensysce Biosciences Initiates First Human Abuse Potential Study

Ensysce Biosciences Inc ENSC initiated the PF614-103 study to evaluate the intranasal abuse potential of PF614 compared with immediate-release oxycodone and placebo in non-dependent recreational opioid users. 

This trial is designed to test and confirm that manipulating and snorting PF614 will not allow the drug abuser to achieve that desired state of euphoria.

Data is expected in September.

BiomX Slashes Workforce By 50%

BiomX Inc PHGE announced a corporate restructuring plan to extend its capital resources at least until the middle of 2024. 

BiomX said it will reduce its operating costs, including a 50% reduction in personnel, while prioritizing the ongoing cystic fibrosis program.

While the restructuring will cause a delay in BiomX's atopic dermatitis program, it plans to support a range of activities that will continue to move this program forward and expects to provide a more detailed program update later in the year.

FDA Approves First Dry Powder Inhaler For Pulmonary Hypertension

The FDA has approved United Therapeutics Corporation's UTHR Tyvaso DPI (treprostinil) inhalation powder for pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) to improve exercise ability. 

Tyvaso DPI represents a new formulation and inhalation device for inhaled treprostinil and is the only dry powder inhaler approved by the FDA for use in PAH and PH-ILD.

FDA Approves First Topical Novel Chemical Entity For Psoriasis In 25 Years

The FDA has approved Dermavant Sciences' Vtama (tapinarof) cream, 1%, for plaque psoriasis in adults. This approval makes Vtama cream the first and only FDA-approved steroid-free topical medication in its class.

Dermavant Sciences is Roivant Sciences Ltd's ROIV subsidiary.

Vtama is an aryl hydrocarbon receptor agonist.

Europe Approves Merck's Keytruda In High-Risk Breast Cancer Setting

The European Commission has approved Merck & Co Inc's MRK Keytruda combined with chemotherapy in locally advanced or early stage triple-negative breast cancer at high risk of recurrence.

The approval comes for Keytruda/chemo combo as neoadjuvant treatment and then continued as monotherapy as adjuvant treatment after surgery for adults.

SpringWorks Cancer Candidate Cuts Risk of Disease Progression By 71%

SpringWorks Therapeutics Inc's SWTX DeFi trial demonstrated a statistically significant improvement for nirogacestat over placebo, with a 71% reduction in the risk of disease progression in desmoid tumors.

In addition, the trial met all key secondary endpoints, with nirogacestat demonstrating statistically significant improvements as compared to placebo in objective response rate and patient-reported outcomes. 

Shares are up 27.9% at $48.61 during the premarket session.

Clinical Readouts/Presentations

AbbVie Inc ABBV: Data from a Phase 3 trial of cariprazine for the adjunctive treatment of the major depressive disorder at the American Psychiatric Association Annual Meeting.

First Wave BioPharma Inc FWBI: James Sapirstein, chairman and chief executive officer, will participate in a "fireside chat" during the H.C. Wainwright Global Investment Conference.

Protagonist Therapeutics Inc PTGX: Topline results from the Phase 2 IDEAL study of PN-943 in moderate-to-severe ulcerative colitis at Digestive Disease Week.

On The Radar


Verrica Pharmaceuticals Inc VRCA: VP-102 for molluscum contagiosum, a viral skin infection that results in round, firm, painless bumps.

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