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Biotechs Search for Innovative Methods to Combat Common Diseases

NEW YORK, March 4, 2019 /PRNewswire/ -- Medical conditions are universally prevalent around the world, especially in areas where people lack access to proper healthcare. The most common forms of deadly medical conditions are coronary artery disease, cancers, diabetes, cirrhosis, and tuberculosis, according to Health Line. Even while many biotechnology companies are focusing on treatments, the number of medical cases are steadily growing every year. On the other hand, the demand to effectively treat or potentially eliminate these conditions is also growing. However, now companies within the industry are beginning to focus on therapeutic and diagnostic solutions such as red biotechnology, recombinant technology, and DNA sequencing. According to data compiled by Variant Market Research, the global biotechnology market is estimated to reach USD 726.8 Billion by 2025. Additionally, the market is expected to exhibit a CAGR of 8.1% from 2017 to 2025. Algernon Pharmaceuticals Inc. (OTC: BTHCF) (CSE: AGN), Kadmon Holdings, Inc. (NYSE: KDMN), Proteostasis Therapeutics, Inc. (NASDAQ: PTI), Proteon Therapeutics, Inc. (NASDAQ: PRTO), TRACON Pharmaceuticals, Inc. (NASDAQ: TCON).

Other common medical conditions that are found around the world include lung diseases. For example, in 2010, lung diseases accounted for over 1 million deaths in the U.S., according to the National Heart, Lung, and Blood Institute. Lung diseases are primarily caused by family genetics, but can also result from allergies, being overweight, smoking, and exposure to pollutants. There are various classifications of lung diseases, such as diseases that affect the airway, air sacs, and blood vessels, but the concern over interstitial lung diseases has recently become more prevalent. Interstitial lung diseases (ILD) affect the interstitium, which is a microscopically thin, delicate lining between the lungs' air sacs. The most common forms of ILDs are idiopathic pulmonary fibrosis (IPF) and sarcoidosis. IPFs cause the lung tissue to scar, changing the lungs' ability to function properly. However, IPFs are just one of the biggest markets within the segment. There is currently no cure for IPFs, therefore, biotechnology companies continually develop and expand upon drugs for treatment. According to Technavio analysts, the global idiopathic pulmonary fibrosis market is expected to grow at a CAGR of 23.97% during the period from 2016 to 2020. "Idiopathic pulmonary fibrosis (IPF) is the most common idiopathic interstitial pneumonia and is increasingly recognized. Prior to the advent of effective therapies, achieving an early diagnosis was arguably of little prognostic consequence given IPF was considered an untreatable and uniformly fatal disease," according to research published on the U.S. National Library of Medicine. "The advent of new drug treatments has given hope for the future and raised the profile of IPF. International management guidelines highlight the critical role of radiology as part of an interstitial lung disease multidisciplinary team approach in reaching an accurate and early diagnosis of IPF."

Algernon Pharmaceuticals Inc. (OTCQB: BTHCF) (CSE: AGN) is also listed on the Canadian Securities Exchange under the ticker (CSE: AGN). Earlier last week, the Company announced breaking news that, "based on positive preliminary data from its first idiopathic pulmonary fibrosis (IPF) study, the Company has decided to conduct further research on compound NP-251.

Because fibrosis is a major underlying condition for many serious diseases, and as a result of the success of several Algernon compounds previously demonstrating anti-fibrotic activity in CKD and NASH, the Company screened a number of its lead compounds for IPF. Out of the 8 compounds screened by the Company during the early research phase, NP - 251 showed the most promise.

The research plan is to advance testing of NP-251 in a new in vivo animal study, directly against clinically relevant doses of both Pirfenidone and Nintedanib, the currently approved treatments for IPF.

"A successful IPF in vivo study for NP-251 would mean that Algernon could begin planning an additional phase II study for its fourth major global disease," said Christopher J. Moreau, CEO of Algernon Pharmaceuticals.' A potential new treatment for IPF could also mean an orphan drug designation, which could help expedite its availability to patients. We look forward to updating the market on our progress shortly.'

About IPF: Idiopathic pulmonary fibrosis is a type of chronic lung disease characterized by a progressive and irreversible decline in lung function and scarring (fibrosis) of the lungs. There is no cure for IPF and there are currently no procedures or medications that can remove the scarring from the lungs.

The idiopathic pulmonary fibrosis (IPF) market will rise substantially from just over $900 million in 2015 to $3.2 billion by 2025, representing an impressive compound annual growth rate (CAGR) of 13.6%. According to research and consulting firm GlobalData's latest report, such growth, which will occur across the seven major markets (7MM) of the USA, France, Germany,
Italy, Spain, the UK, and Japan, will primarily be driven by the increased use of expensive therapies, the anticipated launches of two novel therapies, FibroGen's FG-3019 and Promedior's PRM-151, and a rise in diagnosed prevalent cases of the disease.

About Algernon Pharmaceuticals Inc.: Algernon Pharmaceuticals is a clinical stage pharmaceutical development company focused on advancing its lead compounds for of non–alcoholic steatohepatitis (NASH), chronic kidney disease (CKD) and inflammatory bowel disease (IBD)."

Kadmon Holdings, Inc. (NYSE: KDMN) is a fully integrated biopharmaceutical company developing innovative product candidates for significant unmet medical needs. Kadmon Holdings, Inc. recently announced the presentation of preclinical data supporting the therapeutic potential of Rho-associated coiled-coil kinase (ROCK) inhibition for the treatment of fibrotic diseases. The data was presented by Masha Poyurovsky, Ph.D., Vice President of Molecular Signaling at Kadmon, at the 2nd Annual Anti-Fibrotic Drug Development Summit in Cambridge, MA. Research conducted by Kadmon and others has identified ROCK as an integral component in the pathogenesis of fibrosis. ROCK regulates pro-fibrotic gene transcription, collagen deposition and fibroblast to myofibroblast differentiation, a defining feature of fibrosis. Kadmon has developed a portfolio of ROCK inhibitors in preclinical discovery for the treatment of fibrotic diseases. Its lead candidate from this program, KD045, has been shown to attenuate fibrosis and stabilize barrier function in various in vivo settings, including in models of renal, hepatic and pulmonary fibrosis. Kadmon plans to submit an Investigational New Drug (IND) application for KD045 in the second half of 2019.

Proteostasis Therapeutics, Inc. (NASDAQ: PTI) is a clinical stage biopharmaceutical company developing small molecule therapeutics to treat cystic fibrosis and other diseases caused by dysfunctional protein processing. Proteostasis Therapeutics, Inc. recently announced positive preliminary results from three doublet cohorts of the Company's ongoing Phase 1, randomized, double-blind, placebo-controlled studies of the Company's proprietary combination therapy doublet, PTI-808 and PTI-801, and an enrollment update from the triplet, PTI-808, PTI-801, and PTI-428, in subjects with cystic fibrosis. These studies were designed to assess the safety, tolerability, and pharmacokinetics (PK) of PTI-801, a third-generation cystic fibrosis transmembrane conductance regulator (CFTR) corrector, PTI-808, a novel CFTR potentiator, and PTI-428, a novel CFTR amplifier, compared to placebo over a 14-day dosing period in CF subjects across dose levels of each modulator. Changes in sweat chloride (SC) concentration and in percent predicted FEV1 (ppFEV1) were assessed and evaluated as endpoints. "Doublet combinations, the current standard of care for many CF patients, are the benchmark for current treatment in cystic fibrosis. These data are the first results seen using an entirely new CF doublet, compare favorably to standard of care, and demonstrate the potential of next-generation CFTR modulators to further improve outcomes in this disease," said Carsten Schwarz, MD, Head, Adult Cystic Fibrosis Centre, Lung-Transplantation Program, and Endoscopy Unit, Department of Pediatric Pneumology and Immunology, Charité, Berlin University Medical Center. "I look forward to results from the fourth dosing cohort and to understanding the potential of another novel combination, PTI-801, PTI-808 and PTI-428."

Proteon Therapeutics, Inc. (NASDAQ: PRTO) is committed to improving the health of patients with kidney and vascular diseases through the development of novel, first-in-class therapeutics. Proteon Therapeutics Inc. recently announced the publication in the Journal of Vascular Surgery of results from its Phase 3 PATENCY-1 clinical trial of investigational vonapanitase. Top-line data from PATENCY-1 were publicly announced in December 2016. The study results suggested vonapanitase may improve both fistula use for hemodialysis and secondary patency (time to fistula abandonment), which are the co-primary endpoints in Proteon's ongoing Phase 3 PATENCY-2 clinical trial. The PATENCY-2 clinical trial is fully enrolled and top-line data is expected in March 2019. PATENCY-1 evaluated the safety and efficacy of a single dose of vonapanitase in patients with chronic kidney disease (CKD) undergoing surgical creation of a radiocephalic arteriovenous fistula for hemodialysis. The randomized, double-blind, placebo-controlled clinical trial enrolled 313 treated patients at 31 medical centers in the United States. Patients were followed for up to one year. "While a functioning arteriovenous fistula remains the gold standard for hemodialysis vascular access, failure rates remain unacceptably high, resulting in increased morbidity and mortality and higher health care costs," said Anthony J. Bleyer, M.D., Professor, Nephrology, Wake Forest Baptist Health, and lead author of the publication. "The PATENCY-1 results are promising because of the improvement in fistula use and secondary patency, two clinically meaningful endpoints for patients, their families, and their physicians. I look forward to the results of the ongoing PATENCY-2 trial, in which fistula use and secondary patency are the co-primary endpoints."

TRACON Pharmaceuticals, Inc. (NASDAQ: TCON) develops targeted therapies for cancer, ophthalmic and fibrotic diseases. TRACON Pharmaceuticals recently announced the publication of results from a Phase 1b clinical trial combining TRC105 with Inlyta® (axitinib) in patients with advanced or metastatic renal cell carcinoma (RCC). Dr. Toni Choueiri of the Dana Farber Cancer Institute and colleagues published these results in the peer-reviewed journal, The Oncologist (Epublication ahead of print is available at through PubMed ID number 30190302), and Dr. Andrew Hahn of the Huntsman Cancer Institute and co-authors published an accompanying editorial (Epublication ahead of print is available at through PubMed ID number 30139834).  These data were previously presented at the European Society for Medical Oncology (ESMO) 2016 Congress in Copenhagen, Denmark. The open-label dose escalation and expansion Phase 1b study enrolled a total of 18 patients (17 of whom were evaluable for response) who had received at least one prior line of therapy with a VEGF receptor tyrosine kinase inhibitor (VEGFR TKI).  The median number of prior therapies in the group was three, with a range of one to six. All patients in the trial received a combination of TRC105 and Inlyta. For comparison, in a separate trial, the objective response rate (ORR) seen in the large subgroup of VEGFR TKI-refractory patients treated with Inlyta (n=194) in the Inlyta AXIS Phase 3 study in second-line clear cell RCC patients was 11.3%, and median progression-free survival (PFS) was 4.8 months. 

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